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    Clinical Trial Results:
    A Phase 3 Randomized Withdrawal, Double-blind, Placebo-controlled, Multi-center Study Investigating the Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over, With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

    Summary
    EudraCT number
    		 2018-000501-23
    Trial protocol
    		 BG   NL   BE   PL   DE   LV   SK   ES   IT   RO  
    Global end of trial date
    07 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2021
    First version publication date
    09 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B7451014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03627767
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate and compare the maintenance of effect of two doses of PF-04965842 (200 milligram [mg] and 100 mg once daily [QD]) and placebo in subjects aged 12 and above with moderate to severe atopic dermatitis (AD) who responded to initial open-label (OL) run-in treatment of 200 mg PF-04965842 QD.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 42
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Brazil: 55
    Country: Number of subjects enrolled
    Bulgaria: 14
    Country: Number of subjects enrolled
    Canada: 87
    Country: Number of subjects enrolled
    Chile: 77
    Country: Number of subjects enrolled
    China: 118
    Country: Number of subjects enrolled
    Germany: 54
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Italy: 24
    Country: Number of subjects enrolled
    Latvia: 12
    Country: Number of subjects enrolled
    Mexico: 28
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    Poland: 209
    Country: Number of subjects enrolled
    Romania: 3
    Country: Number of subjects enrolled
    Russian Federation: 99
    Country: Number of subjects enrolled
    Serbia: 12
    Country: Number of subjects enrolled
    Slovakia: 30
    Country: Number of subjects enrolled
    Spain: 72
    Country: Number of subjects enrolled
    Taiwan: 34
    Country: Number of subjects enrolled
    United States: 234
    Worldwide total number of subjects
    1235
    EEA total number of subjects
    441
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    247
    Adults (18-64 years)
    943
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total 1235 subjects were enrolled in 236 sites in 21 countries. Total 1233 subjects received the treatment, 2 subjects were randomised but not treated. Study started from 11 June 2018 and completed on 07 October 2020.

    Period 1
    Period 1 title
    Open-label Run-in Period (12 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PF-04965842 200mg OL
    Arm description
    		 Subjects received 12 weeks induction treatment of 200 mg oral tablets (each tablet of 100 mg) PF-04965842 QD during an open-label run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 week, double-blind (DB), maintenance treatment period. Responder criteria was defined as a) achieving an Investigator’s Global Assessment (IGA) of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (>= 2) points, and c) reaching an Eczema Area and Severity Index-75 (EASI-75) response compared to baseline. Baseline was defined as the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 Long Term Extension (LTE) study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842 200 mg
    Investigational medicinal product code
    Other name
    Abrocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD.

    Number of subjects in period 1 [1]
    		PF-04965842 200mg OL
    Started
    1233
    Completed
    798
    Not completed
    435
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    40
         Withdrawal By Parent/Guardian
    2
         Adverse event, non-fatal
    48
         Medication Error Without Associated Adverse Event
    1
         Unspecified
    4
         Lost to follow-up
    13
         Protocol deviation
    11
         Lack of efficacy
    315
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline analysis was performed on Full analysis set open-label (FAS-OL) which included all subjects who received at least one dose of study medication during the open label run-in phase.
    Period 2
    Period 2 title
    Double-blind Treatment Period (40 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-04965842 200mg OL to Placebo DB
    Arm description
    		 Responders from open-label run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was defined as a loss of at least 50 % of the EASI response at Week 12 and an IGA score of 2 or higher.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received two placebo tablets matched to PF-04965842 orally QD.

    Arm title
    		 PF-04965842 200mg OL to 100mg DB
    Arm description
    		 Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered in open-label rescue period. Flare was defined as a loss of at least 50 percent (%) of the EASI response at Week 12 and an IGA score of 2 or higher.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842 100 mg
    Investigational medicinal product code
    Other name
    Abrocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 100 mg PF-04965842 tablet orally QD.

    Arm title
    		 PF-04965842 200mg OL to 200mg DB
    Arm description
    		 Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered in open-label rescue period. Flare was defined as a loss of at least 50 % of the EASI response at Week 12 and an IGA score of 2 or higher.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842 200 mg
    Investigational medicinal product code
    Other name
    Abrocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD.

    Number of subjects in period 2
    		PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Started
    267
    265
    266
    Subjects entered rescue period
    208 [2]
    109 [3]
    44 [4]
    Completed after entering rescue period
    201 [5]
    99 [6]
    41 [7]
    Completed without entering rescue period
    43 [8]
    134 [9]
    187 [10]
    Completed
    251
    243
    231
    Not completed
    16
    22
    35
         Consent withdrawn by subject
    9
    6
    10
         Adverse event, non-fatal
    6
    7
    19
         Withdrawal By Parent/Guardian
    -
    1
    -
         Unspecified
    -
    1
    1
         Lost to follow-up
    -
    2
    3
         Protocol deviation
    1
    5
    2
    Notes
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.
    Period 3
    Period 3 title
    Open-label Rescue Period (12 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PF-04965842 200 mg Rescue Period
    Arm description
    		 Subjects who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during OL Rescue Period for up to 12 weeks. After completing the 12-week rescue period, subjects had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Subjects who discontinued early from treatment, or who were otherwise ineligible for the LTE study entered were followed-up for 4 week in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842 200 mg
    Investigational medicinal product code
    Other name
    Abrocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD.

    Number of subjects in period 3 [11]
    		PF-04965842 200 mg Rescue Period
    Started
    361
    Met protocol-defined flare criteria
    351
    Completed
    341
    Not completed
    20
         Consent withdrawn by subject
    9
         Adverse event, non-fatal
    9
         Unspecified
    1
         Lost to follow-up
    1
    Notes
    [11] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects who met the protocol defined flare criteria entered in open-label rescue period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-04965842 200mg OL
    Reporting group description
    		 Subjects received 12 weeks induction treatment of 200 mg oral tablets (each tablet of 100 mg) PF-04965842 QD during an open-label run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 week, double-blind (DB), maintenance treatment period. Responder criteria was defined as a) achieving an Investigator’s Global Assessment (IGA) of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (>= 2) points, and c) reaching an Eczema Area and Severity Index-75 (EASI-75) response compared to baseline. Baseline was defined as the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 Long Term Extension (LTE) study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.

    Reporting group values
    		 PF-04965842 200mg OL Total
    Number of subjects
    		 1233 1233
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 246 246
        Adolescents (12-17 years)
    		 942 942
        Adults (18-64 years)
    		 45 45
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender Categorical
    Units: Subjects
        Female
    		 684 684
        Male
    		 549 549
    Race
    Units: Subjects
        White
    		 931 931
        Black or African American
    		 75 75
        Asian
    		 196 196
        American Indian or Alaska Native
    		 7 7
        Multiracial
    		 17 17
        Not Reported
    		 6 6
        Native Hawaiian or Other Pacific Islander
    		 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 246 246
        Not Hispanic or Latino
    		 981 981
        Unknown
    		 1 1
        Not Reported
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    PF-04965842 200mg OL
    Reporting group description
    		 Subjects received 12 weeks induction treatment of 200 mg oral tablets (each tablet of 100 mg) PF-04965842 QD during an open-label run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 week, double-blind (DB), maintenance treatment period. Responder criteria was defined as a) achieving an Investigator’s Global Assessment (IGA) of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (>= 2) points, and c) reaching an Eczema Area and Severity Index-75 (EASI-75) response compared to baseline. Baseline was defined as the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 Long Term Extension (LTE) study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.
    Reporting group title
    PF-04965842 200mg OL to Placebo DB
    Reporting group description
    		 Responders from open-label run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was defined as a loss of at least 50 % of the EASI response at Week 12 and an IGA score of 2 or higher.

    Reporting group title
    PF-04965842 200mg OL to 100mg DB
    Reporting group description
    		 Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered in open-label rescue period. Flare was defined as a loss of at least 50 percent (%) of the EASI response at Week 12 and an IGA score of 2 or higher.

    Reporting group title
    PF-04965842 200mg OL to 200mg DB
    Reporting group description
    		 Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered in open-label rescue period. Flare was defined as a loss of at least 50 % of the EASI response at Week 12 and an IGA score of 2 or higher.
    Reporting group title
    PF-04965842 200 mg Rescue Period
    Reporting group description
    		 Subjects who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during OL Rescue Period for up to 12 weeks. After completing the 12-week rescue period, subjects had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Subjects who discontinued early from treatment, or who were otherwise ineligible for the LTE study entered were followed-up for 4 week in this study.

    Primary: Percentage of Subjects With Loss of Response: Double-blind (DB) Period

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    End point title
    		 Percentage of Subjects With Loss of Response: Double-blind (DB) Period [1]
    End point description
    Loss of response was denoted as flare and was defined as loss of at least 50% of EASI response at Week 12 and an Investigator’s Global Assessment (IGA) score of 2 or higher. EASI quantifies severity of subject’s atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. IGA assesses severity of AD on 5-point scale (0-4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear; 1=almost clear; 2=mild; 3=moderate,; 4=severe. Missing event times were considered as right censored (censored at random [CAR]) on last date of randomised treatment. Full analysis set-randomised (FAS-RA) included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase.
    End point type
    Primary
    End point timeframe
    Up to Week 40
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint.
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    267
    265
    266
    Units: percentage of subjects
        number (not applicable)
    77.5
    39.6
    16.5
    No statistical analyses for this end point

    Primary: Time to Loss of Response: Double-blind Period

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    End point title
    		 Time to Loss of Response: Double-blind Period
    End point description
    Time to loss of response based on achieving IGA >=2 was measured from date of first dose of randomised treatment until last dose of randomised treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12. IGA assesses severity of AD on 5-point scale (0-4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification. FAS-RA population was analysed. Missing event times were considered as right censored (CAR) on last date of randomised treatment. Number of Subjects Analysed=number of subjects evaluable for this endpoint. 99999=data was not evaluable as too few events were observed.
    End point type
    Primary
    End point timeframe
    Up to Week 40
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    207
    105
    44
    Units: days
        median (confidence interval 95%)
    28.0 (28.0 to 29.0)
    323.0 (282.0 to 323.0)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95 percent (%) confidence interval (CI).
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.211
         upper limit
    		 0.341
    Notes
    [2] - A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.136
    Notes
    [3] - A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.255
         upper limit
    		 0.516
    Notes
    [4] - A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.

    Secondary: Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period

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    End point title
    		 Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period
    End point description
    Time to loss of response based on achieving IGA >=2 (for the first time) as measured from date of first dose of randomised treatment until the last dose of randomised treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of atopic dermatitis (AD) on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1=almost clear, AD not entirely cleared, light pink residual lesions; 2=mild, AD with light red lesions; 3=moderate, AD with red lesions; 4=severe, AD with deep, dark red lesions. Missing event times were considered as right censored (CAR) on the last date of randomised treatment. FAS-RA included as all subjects who were randomised at Week 12 and received at least one dose of study medication within the double-blind phase. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From date of first dose of randomised treatment until the last dose of randomised treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to week 40)
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    247
    183
    145
    Units: days
        median (confidence interval 95%)
    27.0 (26.0 to 28.0)
    78.0 (32.0 to 112.0)
    201.0 (177.0 to 282.0)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    430
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.286
         upper limit
    		 0.424
    Notes
    [5] - A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.176
         upper limit
    		 0.27
    Notes
    [6] - A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.503
         upper limit
    		 0.78
    Notes
    [7] - A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.

    Secondary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period

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    End point title
    		 Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period
    End point description
    IGA assessed severity of atopic dermatitis (AD) on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, no inflammatory signs of AD; 1=almost clear, AD not fully cleared, light pink residual lesions; 2=mild, AD with light red lesions; 3=moderate, AD with red lesions; 4=severe, AD with deep dark red lesions. FAS-RA included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase. ‘Number of Subjects Analysed’= subjects evaluable for this endpoint and ‘n’ = number of subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    267
    264
    266
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 12 (n= 266, 264, 265)
    99.6 (98.9 to 100.0)
    99.6 (98.9 to 100.0)
    99.2 (98.2 to 100.0)
        Week 16 (n= 267, 263, 266)
    15.4 (11.0 to 19.7)
    55.5 (49.5 to 61.5)
    77.8 (72.8 to 82.8)
        Week 28 (n= 267, 260, 262)
    10.5 (6.8 to 14.2)
    45.0 (39.0 to 51.0)
    61.8 (55.9 to 67.7)
        Week 40 (n= 265, 260, 259)
    10.6 (6.9 to 14.3)
    42.3 (36.3 to 48.3)
    57.1 (51.1 to 63.2)
        Week 52 (n= 264, 258, 257)
    11.7 (7.9 to 15.6)
    36.8 (30.9 to 42.7)
    54.1 (48.0 to 60.2)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9495 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1.1
    Notes
    [8] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5717 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.9
    Notes
    [9] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 0.9
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    40.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.1
         upper limit
    		 47.8
    Notes
    [10] - P-value was adjusted by disease severity at baseline and randomisation strata
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    62.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 56.1
         upper limit
    		 69.2
    Notes
    [11] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    22.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.3
         upper limit
    		 29.9
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    35.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.1
         upper limit
    		 42
    Notes
    [12] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    51.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 44.6
         upper limit
    		 58.4
    Notes
    [13] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    16.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.1
         upper limit
    		 24.8
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    32.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.2
         upper limit
    		 39.2
    Notes
    [14] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [15]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    46.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 39.9
         upper limit
    		 53.8
    Notes
    [15] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    14.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.9
         upper limit
    		 22.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    25.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.5
         upper limit
    		 32.5
    Notes
    [16] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [17]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    42.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.3
         upper limit
    		 49.7
    Notes
    [17] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    17.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.6
         upper limit
    		 25.5

    Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Percentage of Subjects Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    EASI quantifies severity of subject’s AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin] and lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A=area score. Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. FAS-RA population analysed. Number of Subjects Analysed=subjects evaluable for this endpoint and n=subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    267
    264
    266
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 12 (n= 266, 264, 265)
    100.0 (98.6 to 100.0)
    100.0 (98.6 to 100.0)
    100.0 (98.6 to 100.0)
        Week 16 (n= 267, 263, 266)
    40.8 (34.9 to 46.7)
    83.3 (78.8 to 87.8)
    96.2 (94.0 to 98.5)
        Week 28 (n= 267, 260, 262)
    22.8 (17.8 to 27.9)
    68.1 (62.4 to 73.7)
    85.9 (81.7 to 90.1)
        Week 40 (n= 265, 260, 259)
    16.6 (12.1 to 21.1)
    57.3 (51.3 to 63.3)
    74.9 (69.6 to 80.2)
        Week 52 (n= 264, 258, 257)
    15.9 (11.5 to 20.3)
    50.8 (44.7 to 56.9)
    71.2 (65.7 to 76.7)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions. P-value was adjusted by disease severity at baseline and randomisation strata.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [18]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    42.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.3
         upper limit
    		 50.1
    Notes
    [18] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [19]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    55.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49.1
         upper limit
    		 61.7
    Notes
    [19] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    12.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.9
         upper limit
    		 17.9
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [20]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    45.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 37.9
         upper limit
    		 53
    Notes
    [20] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [21]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 56.4
         upper limit
    		 69.5
    Notes
    [21] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    17.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.7
         upper limit
    		 24.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [22]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.6
         upper limit
    		 48.5
    Notes
    [22] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [23]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    58.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51.3
         upper limit
    		 65.2
    Notes
    [23] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    17.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.6
         upper limit
    		 25.5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [24]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    35.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.8
         upper limit
    		 42.8
    Notes
    [24] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001 [25]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    55.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 48.3
         upper limit
    		 62.4
    Notes
    [25] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    20.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.1
         upper limit
    		 28.5

    Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    EASI quantifies severity of subject’s AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. FAS-RA population analysed. Number of Subjects Analysed=subjects evaluable for this endpoint and n=subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    267
    264
    266
    Units: percentage of Subjects
    number (confidence interval 95%)
        Week 12 (n= 266, 264, 265)
    99.2 (98.2 to 100.0)
    100.0 (98.6 to 100.0)
    99.6 (98.9 to 100.0)
        Week 16 (n= 267, 263, 266)
    27.0 (21.6 to 32.3)
    76.0 (70.9 to 81.2)
    92.5 (89.3 to 95.7)
        Week 28 (n= 267, 260, 262)
    18.0 (13.4 to 22.6)
    60.4 (54.4 to 66.3)
    80.5 (75.7 to 85.3)
        Week 40 (n= 265, 260, 259)
    15.1 (10.8 to 19.4)
    54.2 (48.2 to 60.3)
    71.8 (66.3 to 77.3)
        Week 52 (n= 264, 258, 257)
    14.0 (9.8 to 18.2)
    46.5 (40.4 to 52.6)
    65.8 (60.0 to 71.6)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1848 [26]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 1.7
    Notes
    [26] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5971 [27]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 1.6
    Notes
    [27] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [28]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    49.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42
         upper limit
    		 56.8
    Notes
    [28] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [29]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    65.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 59.3
         upper limit
    		 71.7
    Notes
    [29] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    16.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.3
         upper limit
    		 22.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [30]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    42.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.2
         upper limit
    		 50.2
    Notes
    [30] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [31]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    62.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 56
         upper limit
    		 69.2
    Notes
    [31] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    19.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.3
         upper limit
    		 27.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [32]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    39.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.1
         upper limit
    		 46.9
    Notes
    [32] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [33]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    56.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49.8
         upper limit
    		 63.7
    Notes
    [33] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    17.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.3
         upper limit
    		 25.5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [34]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.7
         upper limit
    		 40.4
    Notes
    [34] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [35]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    51.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 44.6
         upper limit
    		 58.8
    Notes
    [35] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    19.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.8
         upper limit
    		 27.6

    Secondary: Percentage of Subjects Achieving Eczema Area and Severity index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Percentage of Subjects Achieving Eczema Area and Severity index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    EASI quantifies severity of subject’s AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. FAS-RA population analysed. Number of Subjects Analysed=subjects evaluable for this endpoint and n=subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    267
    264
    266
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 12 (n= 266, 264, 265)
    84.6 (80.2 to 88.9)
    87.1 (83.1 to 91.2)
    86.4 (82.3 to 90.5)
        Week 16 (n= 267, 263, 266)
    13.9 (9.7 to 18.0)
    51.3 (45.3 to 57.4)
    77.1 (72.0 to 82.1)
        Week 28 (n= 267, 260, 262)
    10.5 (6.8 to 14.2)
    46.9 (40.9 to 53.0)
    64.5 (58.7 to 70.3)
        Week 40 (n= 265, 260, 259)
    12.1 (8.2 to 16.0)
    41.5 (35.5 to 47.5)
    58.7 (52.7 to 64.7)
        Week 52 (n= 264, 258, 257)
    10.6 (6.9 to 14.3)
    37.6 (31.7 to 43.5)
    54.5 (48.4 to 60.6)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3994 [36]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 8.4
    Notes
    [36] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5542 [37]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 7.8
    Notes
    [37] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [38]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    37.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 30.2
         upper limit
    		 44.9
    Notes
    [38] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [39]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    63.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 56.8
         upper limit
    		 69.8
    Notes
    [39] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    25.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.7
         upper limit
    		 33.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [40]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    36.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.9
         upper limit
    		 44
    Notes
    [40] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [41]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    54.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.3
         upper limit
    		 61
    Notes
    [41] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    17.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.9
         upper limit
    		 25.5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [42]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    29.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.7
         upper limit
    		 37
    Notes
    [42] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [43]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    46.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 39.6
         upper limit
    		 53.8
    Notes
    [43] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    16.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.5
         upper limit
    		 25.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [44]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    27.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.4
         upper limit
    		 34.3
    Notes
    [44] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [45]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    43.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 36.7
         upper limit
    		 50.9
    Notes
    [45] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    16.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.4
         upper limit
    		 25.2

    Secondary: Percentage of Subjects Achieving Eczema Area and Severity index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Percentage of Subjects Achieving Eczema Area and Severity index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    EASI quantifies severity of subject’s AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. FAS-RA population analysed. Number of Subjects Analysed=subjects evaluable for this endpoint and n=subjects evaluable for the specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    267
    264
    266
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 12 (n= 266, 264, 265)
    30.5 (24.9 to 36.0)
    30.3 (24.8 to 35.8)
    28.3 (22.9 to 33.7)
        Week 16 (n= 267, 263, 266)
    3.7 (1.5 to 6.0)
    15.2 (10.9 to 19.5)
    28.9 (23.5 to 34.4)
        Week 28 (n= 267, 260, 262)
    4.1 (1.7 to 6.5)
    16.5 (12.0 to 21.1)
    30.2 (24.6 to 35.7)
        Week 40 (n= 265, 260, 259)
    4.5 (2.0 to 7.0)
    15.8 (11.3 to 20.2)
    30.1 (24.5 to 35.7)
        Week 52 (n= 264, 258, 257)
    4.5 (2.0 to 7.1)
    18.6 (13.9 to 23.4)
    28.8 (23.3 to 34.3)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9313 [46]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 8.1
    Notes
    [46] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6043 [47]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.8
         upper limit
    		 5.7
    Notes
    [47] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 5.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [48]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    11.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.6
         upper limit
    		 16.5
    Notes
    [48] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [49]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    25.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.4
         upper limit
    		 31.2
    Notes
    [49] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    13.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.6
         upper limit
    		 20.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [50]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    12.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.7
         upper limit
    		 18
    Notes
    [50] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [51]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.9
         upper limit
    		 32
    Notes
    [51] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    13.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.3
         upper limit
    		 20.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [52]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.5
         upper limit
    		 16.8
    Notes
    [52] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [53]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    25.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.6
         upper limit
    		 31.8
    Notes
    [53] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    14.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7
         upper limit
    		 21.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    531
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [54]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    14.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.2
         upper limit
    		 20
    Notes
    [54] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [55]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    24.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.4
         upper limit
    		 30.5
    Notes
    [55] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 17.2

    Secondary: Percentage of Subjects With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Percentage of Subjects With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    Subjects were asked to assess their itch at the worst moment over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity. FAS-RA included as all subjects who were randomised at Week 12 and received at least one dose of study medication within the DB phase. Here ‘Number of Subjects Analysed’ signifies subjects evaluable for this endpoint and ‘n’ signifies number of subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    258
    254
    250
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 12 (n= 230, 237, 232)
    82.2 (77.2 to 87.1)
    84.0 (79.3 to 88.6)
    81.9 (76.9 to 86.9)
        Week 16 (n= 252, 251, 250)
    15.9 (11.4 to 20.4)
    54.6 (48.4 to 60.7)
    75.6 (70.3 to 80.9)
        Week 28 (n= 258, 251, 245)
    11.6 (7.7 to 15.5)
    45.0 (38.9 to 51.2)
    66.9 (61.0 to 72.8)
        Week 40 (n= 257, 254, 246)
    10.1 (6.4 to 13.8)
    39.4 (33.4 to 45.4)
    55.7 (49.5 to 61.9)
        Week 52 (n= 252, 216, 204)
    8.3 (4.9 to 11.7)
    27.3 (21.4 to 33.3)
    49.0 (42.2 to 55.9)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6082 [56]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 8.5
    Notes
    [56] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.964 [57]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 7
    Notes
    [57] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 4.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [58]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    38.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.2
         upper limit
    		 46.5
    Notes
    [58] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [59]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    59.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 52.7
         upper limit
    		 66.7
    Notes
    [59] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    20.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.7
         upper limit
    		 29
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [60]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    33.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.6
         upper limit
    		 41.2
    Notes
    [60] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [61]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    55.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 48.2
         upper limit
    		 62.3
    Notes
    [61] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    21.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.2
         upper limit
    		 30.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [62]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    29.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.7
         upper limit
    		 36.7
    Notes
    [62] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [63]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    45.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 38.4
         upper limit
    		 52.7
    Notes
    [63] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.4
         upper limit
    		 24.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [64]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    19.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.7
         upper limit
    		 26.4
    Notes
    [64] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [65]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    40.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.8
         upper limit
    		 48.1
    Notes
    [65] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    21.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.1
         upper limit
    		 30.3

    Secondary: Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of subject’s hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity. FAS-RA population analysed. Number of Subjects Analysed=subjects evaluable for this endpoint and n=subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    266
    264
    265
    Units: percent change in BSA
    median (inter-quartile range (Q1-Q3))
        Change at Week 12 (n= 266, 264, 265)
    -95.6 (-100.0 to -88.5)
    -96.7 (-100.0 to -91.5)
    -96.7 (-100.0 to -89.2)
        Change at Week 16 (n= 135, 223, 256)
    -68.5 (-89.8 to -37.5)
    -90.9 (-97.6 to -78.3)
    -96.3 (-100.0 to -88.7)
        Change at Week 28 (n= 64, 180, 227)
    -85.2 (-95.8 to -63.5)
    -93.8 (-99.5 to -81.4)
    -96.4 (-100.0 to -85.7)
        Change at Week 40 (n= 46, 151, 197)
    -91.2 (-100.0 to -77.9)
    -95.8 (-100.0 to -83.5)
    -96.8 (-100.0 to -88.8)
        Change at Week 52 (n= 42, 134, 185)
    -91.5 (-100.0 to -77.9)
    -96.9 (-100.0 to -83.4)
    -96.9 (-100.0 to -88.2)
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by subject/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. FAS-RA was analysed. Number of Subjects Analysed=subjects evaluable for endpoint and n=subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    265
    264
    265
    Units: percent change in SCORAD total score
    median (inter-quartile range (Q1-Q3))
        Change at Week 12 (n= 265, 264, 265)
    -84.0 (-94.7 to -73.5)
    -84.4 (-95.2 to -74.9)
    -84.4 (-93.8 to -74.2)
        Change at Week 16 (n= 134, 224, 256)
    -50.4 (-68.3 to -32.1)
    -71.7 (-87.8 to -60.5)
    -83.6 (-95.1 to -70.6)
        Change at Week 28 (n= 62, 177, 227)
    -63.4 (-81.9 to -48.3)
    -77.8 (-90.2 to -62.6)
    -83.8 (-97.4 to -66.4)
        Change at Week 40 (n= 46, 152, 196)
    -74.4 (-89.5 to -60.6)
    -77.1 (-94.1 to -64.3)
    -84.6 (-98.6 to -68.4)
        Change at Week 52 (n= 43, 132, 184)
    -73.3 (-89.8 to -58.0)
    -82.5 (-97.7 to -64.1)
    -83.2 (-100.0 to -69.1)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by subject/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. FAS-RA was analysed. Number of Subjects Analysed=subjects evaluable for endpoint and n=subjects evaluable at the specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    264
    264
    261
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Pruritus VAS: Change at Week 12 (n=264, 264, 261)
    -6.1 (-6.3 to -5.9)
    -6.1 (-6.3 to -5.9)
    -6.1 (-6.3 to -5.9)
        Pruritus VAS: Change at Week 16 (n=264, 264, 261)
    3.4 (3.0 to 3.7)
    1.2 (1.0 to 1.5)
    0.2 (-0.1 to 0.4)
        Pruritus VAS: Change at Week 28 (n=264, 264, 261)
    2.4 (1.9 to 2.9)
    1.1 (0.8 to 1.4)
    0.5 (0.3 to 0.8)
        Pruritus VAS: Change at Week 40 (n=264, 264, 261)
    2.2 (1.6 to 2.8)
    1.2 (0.9 to 1.6)
    0.4 (0.1 to 0.7)
        Pruritus VAS: Change at Week 52 (n=264, 264, 261)
    1.8 (1.2 to 2.4)
    1.3 (0.9 to 1.6)
    0.5 (0.2 to 0.8)
        Sleep Loss VAS: Change at Week 12 (n=264,264,260)
    -5.0 (-5.2 to -4.8)
    -5.0 (-5.2 to -4.8)
    -5.1 (-5.3 to -4.9)
        Sleep Loss VAS: Change at Week 16 (n=264,264,260)
    2.3 (2.0 to 2.6)
    0.5 (0.3 to 0.8)
    0.0 (-0.2 to 0.2)
        Sleep Loss VAS: Change at Week 28 (n=264,264,260)
    1.3 (0.9 to 1.7)
    0.6 (0.4 to 0.9)
    0.2 (0.0 to 0.4)
        Sleep Loss VAS: Change at Week 40 (n=264,264,260)
    1.3 (0.8 to 1.8)
    0.6 (0.3 to 0.9)
    0.2 (0.0 to 0.4)
        Sleep Loss VAS: Change at Week 52 (n=264,264,260)
    1.2 (0.7 to 1.8)
    0.9 (0.5 to 1.2)
    0.3 (0.0 to 0.5)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Pruritus VAS: Week 12: The least squares mean (LSM) differences between treatment groups were derived from the statistical model. Mixed model repeated measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9207
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9998
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM differences
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.3
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM differences
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM differences
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -1.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM differences
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 -2.8
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM differences
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM differences
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 -0.8
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -1.3
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 -0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0039
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 -0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -1.2
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1488
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 -0.6
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9294
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4081
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.1
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 -1.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 -2
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 -0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0035
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.7
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0136
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.6
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2887
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0025
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.3
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    525
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 -0.2

    Secondary: Percentage of Subjects With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Percentage of Subjects With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by subject/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. FAS-RA was analysed. Number of Subjects Analysed = subjects evaluable for this endpoint and n=subjects evaluable at the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    266
    264
    266
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 12 (n= 265, 264, 265)
    97.4 (95.4 to 99.3)
    98.5 (97.0 to 100.0)
    97.0 (94.9 to 99.0)
        Week 16 (n= 266, 264, 266)
    25.6 (20.3 to 30.8)
    72.0 (66.6 to 77.4)
    89.1 (85.4 to 92.8)
        Week 28 (n= 266, 259, 263)
    15.8 (11.4 to 20.2)
    56.8 (50.7 to 62.8)
    75.7 (70.5 to 80.9)
        Week 40 (n= 264, 260, 258)
    14.4 (10.2 to 18.6)
    51.2 (45.1 to 57.2)
    69.0 (63.3 to 74.6)
        Week 52 (n= 264, 258, 257)
    14.8 (10.5 to 19.1)
    44.6 (38.5 to 50.6)
    65.8 (60.0 to 71.6)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4244 [66]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 3.4
    Notes
    [66] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8092 [67]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 2.4
    Notes
    [67] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [68]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    46.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 39.2
         upper limit
    		 54.2
    Notes
    [68] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [69]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    63.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 57.2
         upper limit
    		 70
    Notes
    [69] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.4
         upper limit
    		 23.5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [70]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    41.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.9
         upper limit
    		 48.7
    Notes
    [70] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [71]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    59.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 53.1
         upper limit
    		 66.7
    Notes
    [71] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    18.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.8
         upper limit
    		 26.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [72]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.6
         upper limit
    		 44.4
    Notes
    [72] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [73]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    54.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.6
         upper limit
    		 61.7
    Notes
    [73] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    17.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.4
         upper limit
    		 26
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [74]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.6
         upper limit
    		 37.4
    Notes
    [74] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [75]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    50.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 43.8
         upper limit
    		 58.1
    Notes
    [75] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.8
         upper limit
    		 29.5

    Secondary: Percentage of Subjects With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period

    		 Close Top of page
    End point title
    		 Percentage of Subjects With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by subject/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. FAS-RA was analysed. Number of Subjects Analysed=subjects evaluable for endpoint and n=subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    266
    264
    266
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 12 (n= 265, 264, 265)
    73.6 (68.3 to 78.9)
    75.0 (69.8 to 80.2)
    71.3 (65.9 to 76.8)
        Week 16 (n= 266, 264, 266)
    9.4 (5.9 to 12.9)
    38.3 (32.4 to 44.1)
    67.3 (61.7 to 72.9)
        Week 28 (n= 266, 259, 263)
    7.5 (4.3 to 10.7)
    37.8 (31.9 to 43.7)
    56.3 (50.3 to 62.3)
        Week 40 (n= 264, 260, 258)
    8.3 (5.0 to 11.7)
    32.7 (27.0 to 38.4)
    47.7 (41.6 to 53.8)
        Week 52 (n= 264, 258, 257)
    7.6 (4.4 to 10.8)
    31.8 (26.1 to 37.5)
    45.9 (39.8 to 52.0)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7232 [76]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 8.8
    Notes
    [76] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5694 [77]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.8
         upper limit
    		 5.4
    Notes
    [77] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.2
         upper limit
    		 3.8
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [78]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.2
         upper limit
    		 35.8
    Notes
    [78] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [79]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    57.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51.2
         upper limit
    		 64.5
    Notes
    [79] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    28.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.8
         upper limit
    		 37
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [80]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    30.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.9
         upper limit
    		 37.2
    Notes
    [80] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [81]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    48.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42.1
         upper limit
    		 55.6
    Notes
    [81] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    18.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.8
         upper limit
    		 26.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [82]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.4
         upper limit
    		 31.5
    Notes
    [82] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [83]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    39.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.7
         upper limit
    		 46.5
    Notes
    [83] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    14.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.3
         upper limit
    		 22.8
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [84]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    24.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.1
         upper limit
    		 31.2
    Notes
    [84] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [85]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    38.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.6
         upper limit
    		 45.3
    Notes
    [85] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    13.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.6
         upper limit
    		 22.3

    Secondary: Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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    End point title
    		 Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period
    End point description
    IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions. Full analysis set - rescue (FAS-RE) included all subjects who met the protocol definition of a flare during the DB phase and received at least one dose of rescue treatment. Rescue baseline was defined as the last measurement collected between last dose of blinded treatment and Day 1 of rescue treatment. Here ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint and ‘n’ signifies subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Rescue Baseline, Rescue Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 200 mg Rescue Period
    Number of subjects analysed
    342
    Units: percentage of subjects
    number (confidence interval 95%)
        Rescue Week 2 (n= 332)
    30.7 (25.8 to 35.7)
        Rescue Week 4 (n= 337)
    54.6 (49.3 to 59.9)
        Rescue Week 8 (n= 342)
    60.2 (55.0 to 65.4)
        Rescue Week 12 (n= 337)
    64.1 (59.0 to 69.2)
    No statistical analyses for this end point

    Secondary: Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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    End point title
    		 Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period
    End point description
    EASI quantifies severity of subject’s AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. FAS-RE population analysed. Here, 'Number of Subjects Analysed' signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Rescue Baseline, Rescue Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 200 mg Rescue Period
    Number of subjects analysed
    348
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Rescue Week 2
    -71.1 (-73.7 to -68.5)
        Change at Rescue Week 4
    -82.0 (-84.2 to -79.7)
        Change at Rescue Week 8
    -86.4 (-88.2 to -84.6)
        Change at Rescue Week 12
    -87.3 (-89.4 to -85.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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    End point title
    		 Percentage of Subjects Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period
    End point description
    Subjects were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity. FAS-RE included all subjects who met the protocol definition of a flare during the DB phase and received at least one dose of rescue treatment. Rescue baseline was defined as the last measurement collected between last dose of blinded treatment and Day 1 of rescue treatment. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint and ‘n’ signifies subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Rescue Baseline, Rescue Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 200 mg Rescue Period
    Number of subjects analysed
    272
    Units: percentage of subjects
    number (confidence interval 95%)
        Rescue Week 2 (n= 272)
    56.6 (50.7 to 62.5)
        Rescue Week 4 (n= 250)
    63.2 (57.2 to 69.2)
        Rescue Week 8 (n= 253)
    67.2 (61.4 to 73.0)
        Rescue Week 12 (n= 153)
    56.2 (48.3 to 64.1)
    No statistical analyses for this end point

    Secondary: Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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    End point title
    		 Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period
    End point description
    4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of subject's hand with fingers in a closed position) fitting in affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD. FAS-RE analysed. Rescue baseline was defined as the last measurement collected between last dose of blinded treatment and Day 1 of rescue treatment. Number of Subjects Analysed = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Rescue Baseline, Rescue Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 200 mg Rescue Period
    Number of subjects analysed
    348
    Units: percent change in BSA
    least squares mean (confidence interval 95%)
        Change at Rescue Week 2
    -62.8 (-66.0 to -59.6)
        Change at Rescue Week 4
    -76.4 (-79.1 to -73.7)
        Change at Rescue Week 8
    -82.1 (-84.5 to -79.6)
        Change at Rescue Week 12
    -83.3 (-86.0 to -80.5)
    No statistical analyses for this end point

    Secondary: Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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    End point title
    		 Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period
    End point description
    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by subject/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. FAS-RE analysed. Number of Subjects Analysed = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Rescue Baseline, Rescue Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 200 mg Rescue Period
    Number of subjects analysed
    347
    Units: percent change in SCORAD VAS score
    least squares mean (confidence interval 95%)
        Pruritus VAS: Change at Rescue Week 2
    -57.3 (-61.7 to -52.9)
        Pruritus VAS: Change at Rescue Week 4
    -67.5 (-71.3 to -63.7)
        Pruritus VAS: Change at Rescue Week 8
    -68.6 (-73.6 to -63.7)
        Pruritus VAS: Change at Rescue Week 12
    -67.3 (-72.8 to -61.8)
        Sleep Loss VAS: Change at Rescue Week 2
    -62.5 (-69.1 to -55.9)
        Sleep Loss VAS: Change at Rescue Week 4
    -72.4 (-78.6 to -66.3)
        Sleep Loss VAS: Change at Rescue Week 8
    -75.8 (-82.0 to -69.5)
        Sleep Loss VAS: Change at Rescue Week 12
    -74.5 (-81.4 to -67.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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    End point title
    		 Percentage of Subjects With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period
    End point description
    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by subject/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. FAS-RE analysed. Number of Subjects Analysed = subjects evaluable for this endpoint and n=subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Rescue Baseline, Rescue Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 200 mg Rescue Period
    Number of subjects analysed
    339
    Units: percentage of subjects
    number (confidence interval 95%)
        Rescue Week 2 (n= 331)
    55.0 (49.6 to 60.3)
        Rescue Week 4 (n= 339)
    76.1 (71.6 to 80.6)
        Rescue Week 8 (n= 338)
    79.6 (75.3 to 83.9)
        Rescue Week 12 (n= 337)
    79.8 (75.5 to 84.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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    End point title
    		 Percentage of Subjects With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period
    End point description
    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by subject/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. FAS-RE analysed. Number of Subjects Analysed = subjects evaluable for this endpoint and n=subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Rescue Baseline, Rescue Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 200 mg Rescue Period
    Number of subjects analysed
    339
    Units: percentage of subjects
    number (confidence interval 95%)
        Rescue Week 2 (n= 331)
    16.9 (12.9 to 21.0)
        Rescue Week 4 (n= 339)
    33.9 (28.9 to 39.0)
        Rescue Week 8 (n= 338)
    44.4 (39.1 to 49.7)
        Rescue Week 12 (n= 337)
    45.4 (40.1 to 50.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Percentage of Subjects Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    Subject responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity. FAS-RA included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase. Here ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint and ‘n’ signifies subjects evaluable for the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    254
    262
    259
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 12 (n= 253, 262, 258)
    61.7 (55.7 to 67.7)
    64.5 (58.7 to 70.3)
    59.7 (53.7 to 65.7)
        Week 16 (n= 254, 262, 259)
    5.9 (3.0 to 8.8)
    29.8 (24.2 to 35.3)
    48.3 (42.2 to 54.3)
        Week 28 (n= 253, 259, 256)
    6.3 (3.3 to 9.3)
    30.9 (25.3 to 36.5)
    46.9 (40.8 to 53.0)
        Week 40 (n= 252, 257, 250)
    7.5 (4.3 to 10.8)
    26.1 (20.7 to 31.4)
    42.0 (35.9 to 48.1)
        Week 52 (n= 251, 256, 247)
    7.6 (4.3 to 10.8)
    25.8 (20.4 to 31.1)
    39.7 (33.6 to 45.8)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    516
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4815 [86]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 11.3
    Notes
    [86] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6748 [87]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 6.6
    Notes
    [87] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.4
         upper limit
    		 3.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    516
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [88]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.8
         upper limit
    		 30.3
    Notes
    [88] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [89]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    42.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.6
         upper limit
    		 49
    Notes
    [89] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    18.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.2
         upper limit
    		 26.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    516
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [90]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    24.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.2
         upper limit
    		 31
    Notes
    [90] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [91]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    40.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.7
         upper limit
    		 47.3
    Notes
    [91] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.6
         upper limit
    		 24.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    516
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [92]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    18.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.6
         upper limit
    		 25.1
    Notes
    [92] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [93]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    34.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.6
         upper limit
    		 41.5
    Notes
    [93] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.5
         upper limit
    		 23.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    516
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [94]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    18.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.4
         upper limit
    		 25
    Notes
    [94] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [95]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    32.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.4
         upper limit
    		 39.2
    Notes
    [95] - P-value was adjusted by disease severity at baseline and randomisation strata.
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomisation stratum and disease severity at baseline using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    13.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.6
         upper limit
    		 21.7

    Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of subjects. FAS-RA included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase. Here ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    217
    215
    217
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 12
    -13.5 (-13.9 to -13.0)
    -13.4 (-13.8 to -12.9)
    -13.5 (-14.0 to -13.1)
        Change at Week 16
    6.9 (6.1 to 7.8)
    1.9 (1.2 to 2.5)
    0.4 (-0.2 to 1.0)
        Change at Week 28
    6.1 (5.0 to 7.1)
    2.1 (1.4 to 2.7)
    0.9 (0.3 to 1.5)
        Change at Week 40
    4.4 (3.0 to 5.7)
    2.5 (1.7 to 3.2)
    1.1 (0.5 to 1.8)
        Change at Week 52
    3.6 (2.1 to 5.0)
    2.8 (2.0 to 3.6)
    0.9 (0.2 to 1.6)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7373
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    434
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8092
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.5
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 -4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    434
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 -5.5
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -0.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 -2.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    434
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.4
         upper limit
    		 -3.9
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 -0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 -0.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    434
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 -1.7
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 -0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3616
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 0.9
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    434
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0012
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 -1.1
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    432
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 -0.8

    Secondary: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. FAS-RA included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase. Here ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    49
    48
    47
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 12
    -9.8 (-10.6 to -8.9)
    -9.2 (-10.0 to -8.3)
    -9.3 (-10.2 to -8.5)
        Change at Week 16
    5.9 (4.4 to 7.5)
    1.7 (0.5 to 2.9)
    -0.3 (-1.4 to 0.8)
        Change at Week 28
    1.5 (-0.2 to 3.2)
    1.6 (0.6 to 2.6)
    0.4 (-0.5 to 1.3)
        Change at Week 40
    2.1 (0.3 to 3.8)
    1.7 (0.7 to 2.7)
    0.0 (-0.9 to 0.9)
        Change at Week 52
    2.3 (0.3 to 4.4)
    1.3 (0.0 to 2.6)
    0.4 (-0.6 to 1.4)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3339
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1.8
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4653
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 1.7
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.2
         upper limit
    		 -2.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2
         upper limit
    		 -4.3
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 -0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9083
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 2.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2439
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 0.8
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7405
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 1.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 -0.1
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 -0.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4026
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 1.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0944
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 0.3
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 0.7

    Secondary: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    HADS: subject rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. FAS-RA included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase. Here ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    266
    263
    264
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 12
    -2.7 (-3.0 to -2.3)
    -2.6 (-2.9 to -2.3)
    -2.6 (-2.9 to -2.3)
        Change at Week 16
    1.4 (1.0 to 1.8)
    0.3 (0.0 to 0.6)
    0.0 (-0.3 to 0.3)
        Change at Week 28
    1.0 (0.5 to 1.5)
    0.4 (0.1 to 0.7)
    0.1 (-0.2 to 0.4)
        Change at Week 40
    1.0 (0.4 to 1.6)
    0.4 (0.1 to 0.8)
    0.1 (-0.3 to 0.4)
        Change at Week 52
    0.8 (0.2 to 1.4)
    0.4 (0.1 to 0.8)
    0.2 (-0.1 to 0.5)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7556
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7484
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.6
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 -0.9
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0242
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0012
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.4
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.124
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0107
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.2
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3139
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0853
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.1
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 200mg DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.2

    Secondary: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period

    		 Close Top of page
    End point title
    		 Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    HADS: subject rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. FAS-RA included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase. Here ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    266
    263
    264
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 12
    -2.0 (-2.3 to -1.7)
    -1.6 (-1.9 to -1.3)
    -1.7 (-2.0 to -1.4)
        Change at Week 16
    1.4 (1.0 to 1.8)
    0.0 (-0.3 to 0.3)
    0.0 (-0.2 to 0.3)
        Change at Week 28
    0.7 (0.2 to 1.1)
    0.3 (0.0 to 0.5)
    0.1 (-0.2 to 0.4)
        Change at Week 40
    0.8 (0.2 to 1.4)
    -0.1 (-0.4 to 0.3)
    0.2 (-0.1 to 0.5)
        Change at Week 52
    0.4 (-0.1 to 0.9)
    -0.1 (-0.4 to 0.2)
    0.1 (-0.2 to 0.3)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0674
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.8
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1437
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.7
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 -0.9
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 -0.9
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1136
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0276
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 -0.1
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0108
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0677
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.132
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2975
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.3
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.6

    Secondary: Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    POEM was a 7-item subject reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The score ranges from 0 to 28, where higher score indicated greater severity. FAS-RA included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase. Here, ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    265
    263
    263
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 12
    -15.4 (-16.0 to -14.8)
    -15.8 (-16.4 to -15.2)
    -15.4 (-16.0 to -14.8)
        Change at Week 16
    9.8 (8.9 to 10.7)
    3.7 (3.0 to 4.4)
    0.6 (-0.1 to 1.2)
        Change at Week 28
    8.3 (6.9 to 9.7)
    3.7 (2.8 to 4.6)
    1.6 (0.8 to 2.4)
        Change at Week 40
    7.4 (5.8 to 9.1)
    4.8 (3.9 to 5.8)
    1.9 (1.1 to 2.8)
        Change at Week 52
    7.3 (5.4 to 9.2)
    4.9 (3.8 to 6.0)
    2.2 (1.3 to 3.2)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3531
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9282
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.9
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 1.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 -5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 -8.1
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 -2.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.2
         upper limit
    		 -2.9
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 -5.1
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -0.9
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0082
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 -0.7
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 -3.6
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 -1.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0313
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 -0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 -3
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 -1.3

    Secondary: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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    End point title
    		 Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period
    End point description
    PSAAD is a daily subject reported symptom electronic diary. Subjects rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [darker or lighter], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Subject had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. FAS-RA included as all subjects who were randomised at Week 12 and received at least 1 dose of study medication within DB phase. Here ‘Number of Subjects Analysed’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 16, 28, 40 and 52
    End point values
    		 PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB
    Number of subjects analysed
    254
    260
    254
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 12
    -4.1 (-4.3 to -3.9)
    -4.2 (-4.4 to -4.0)
    -4.2 (-4.4 to -4.0)
        Change at Week 16
    2.1 (1.9 to 2.2)
    0.8 (0.6 to 0.9)
    0.1 (-0.1 to 0.3)
        Change at Week 28
    2.3 (2.0 to 2.6)
    1.0 (0.8 to 1.2)
    0.1 (-0.1 to 0.3)
        Change at Week 40
    2.0 (1.7 to 2.4)
    1.0 (0.8 to 1.3)
    0.3 (0.0 to 0.5)
        Change at Week 52
    1.9 (1.5 to 2.3)
    1.2 (0.9 to 1.4)
    0.2 (0.0 to 0.5)
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4832
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.2
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6553
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.2
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -1.1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -1.7
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 -0.4
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 -1
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -1.8
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 -0.5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.6
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -1.4
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 -0.5
    Statistical analysis title
    		 Placebo DB vs PF-04965842 100mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 100mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.3
    Statistical analysis title
    		 Placebo DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to Placebo DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    508
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -1.2
    Statistical analysis title
    		 PF-04965842 100mg DB vs PF-04965842 200mg DB
    Statistical analysis description
    Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomisation strata, baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200mg OL to 100mg DB v PF-04965842 200mg OL to 200mg DB
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 LSM difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening up to 28 days after last dose of study treatment (maximum up to week 56)
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least 1 dose of study medication.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    PF-04965842 200mg OL
    Reporting group description
    		 Subjects received 12 weeks induction treatment of 200 milligram (mg) oral tablets (each tablet of 100 mg) PF-04965842 QD during an OL run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 week, double-blind, maintenance treatment period. Responder criteria was defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (>= 2) points, and c) reaching an EASI-75 response compared to baseline. Baseline was defined as the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 LTE study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study.

    Reporting group title
    PF-04965842 200mg OL to Placebo DB
    Reporting group description
    		 Responders from open-label run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered an open-label rescue period. Flare was defined as a loss of at least 50 % of the EASI response at Week 12 and an IGA score of 2 or higher.

    Reporting group title
    PF-04965842 200mg OL to 100mg DB
    Reporting group description
    		 Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered an open-label rescue period. Flare was defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.

    Reporting group title
    PF-04965842 200mg OL to 200mg DB
    Reporting group description
    		 Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Subjects who met the protocol defined flare criteria entered an open-label rescue period. Flare was defined as a loss of at least 50 % of the EASI response at Week 12 and an IGA score of 2 or higher.

    Reporting group title
    PF-04965842 200 mg Rescue Period
    Reporting group description
    		 Subjects who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during OL Rescue Period for up to 12 weeks. After completing the 12-week rescue period, subjects had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Subjects who discontinued early from treatment, or who were otherwise ineligible for the LTE study entered were followed-up for 4 week in this study.

    Serious adverse events
    		 PF-04965842 200mg OL PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB PF-04965842 200 mg Rescue Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 1233 (1.62%)
    2 / 267 (0.75%)
    4 / 265 (1.51%)
    13 / 266 (4.89%)
    4 / 351 (1.14%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    1 / 265 (0.38%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adnexa uteri cyst
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Vitello-intestinal duct remnant
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Microcytic anaemia
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    1 / 265 (0.38%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulcerative keratitis
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 1233 (0.24%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    2 / 351 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haemarthrosis
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess neck
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 1233 (0.16%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema herpeticum
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    1 / 265 (0.38%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 1233 (0.00%)
    1 / 267 (0.37%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 1233 (0.00%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    1 / 266 (0.38%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 1233 (0.08%)
    1 / 267 (0.37%)
    1 / 265 (0.38%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 1233 (0.08%)
    0 / 267 (0.00%)
    0 / 265 (0.00%)
    0 / 266 (0.00%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PF-04965842 200mg OL PF-04965842 200mg OL to Placebo DB PF-04965842 200mg OL to 100mg DB PF-04965842 200mg OL to 200mg DB PF-04965842 200 mg Rescue Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    466 / 1233 (37.79%)
    91 / 267 (34.08%)
    72 / 265 (27.17%)
    81 / 266 (30.45%)
    74 / 351 (21.08%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    43 / 1233 (3.49%)
    1 / 267 (0.37%)
    6 / 265 (2.26%)
    14 / 266 (5.26%)
    9 / 351 (2.56%)
         occurrences all number
    43
    1
    7
    16
    11
    Nervous system disorders
    Headache
         subjects affected / exposed
    119 / 1233 (9.65%)
    1 / 267 (0.37%)
    1 / 265 (0.38%)
    7 / 266 (2.63%)
    12 / 351 (3.42%)
         occurrences all number
    142
    1
    1
    11
    13
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    199 / 1233 (16.14%)
    1 / 267 (0.37%)
    2 / 265 (0.75%)
    8 / 266 (3.01%)
    12 / 351 (3.42%)
         occurrences all number
    241
    1
    4
    9
    12
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    68 / 1233 (5.52%)
    0 / 267 (0.00%)
    5 / 265 (1.89%)
    8 / 266 (3.01%)
    7 / 351 (1.99%)
         occurrences all number
    69
    0
    5
    9
    7
    Dermatitis atopic
         subjects affected / exposed
    45 / 1233 (3.65%)
    83 / 267 (31.09%)
    51 / 265 (19.25%)
    33 / 266 (12.41%)
    13 / 351 (3.70%)
         occurrences all number
    46
    85
    54
    33
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    77 / 1233 (6.24%)
    5 / 267 (1.87%)
    10 / 265 (3.77%)
    18 / 266 (6.77%)
    17 / 351 (4.84%)
         occurrences all number
    78
    5
    12
    20
    20
    Upper respiratory tract infection
         subjects affected / exposed
    63 / 1233 (5.11%)
    6 / 267 (2.25%)
    8 / 265 (3.02%)
    8 / 266 (3.01%)
    21 / 351 (5.98%)
         occurrences all number
    70
    7
    9
    8
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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