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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study Investigating the Efficacy and Safety of PF-04965842 Co-administered With Background Medicated Topical Therapy in Adolescent Participants 12 to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2018-003804-37
    Trial protocol
    		 HU   CZ   LV   PL   GB   DE   IT  
    Global end of trial date
    08 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Oct 2020
    First version publication date
    17 Oct 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B7451036
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03796676
    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., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to assess the efficacy of PF-04965842 compared with placebo when coadministered with background medicated topical therapy in adolescent subjects 12 to <18 years of age with moderate-to-severe atopic dermatitis (AD).
    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
    		 Medicated topical therapy (topical corticosteroid or topical calcineurin inhibitors or phosphodiesterase type 4 [PDE4] inhibitor)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    China: 52
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Japan: 26
    Country: Number of subjects enrolled
    Latvia: 2
    Country: Number of subjects enrolled
    Mexico: 23
    Country: Number of subjects enrolled
    Poland: 43
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Taiwan: 8
    Country: Number of subjects enrolled
    United States: 80
    Worldwide total number of subjects
    285
    EEA total number of subjects
    87
    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)
    1
    Adolescents (12-17 years)
    283
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 408 subjects were screened, 287 subjects were enrolled and assigned to 1 of 3 treatments. Only 285 subjects received the study treatment and 2 subjects withdrew prior to dosing.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-04965842 100mg QD
    Arm description
    		 Subjects in this treatment group received PF-04965842 100 mg once daily (QD) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1 tablet of PF-04965842 100 mg and 1 tablet of placebo QD.

    Arm title
    		 PF-04965842 200mg QD
    Arm description
    		 Subjects in this treatment group received PF-04965842 200 mg QD for 12 weeks.
    Arm type
    		 Experimental

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

    Arm title
    		 Placebo
    Arm description
    		 Subjects in this treatment group received PF-04965842-matching placebo QD for 12 weeks.
    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 2 tablets of PF-04965842 matching placebo QD.

    Number of subjects in period 1
    		PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Started
    95
    94
    96
    Completed
    92
    91
    90
    Not completed
    3
    3
    6
         Adverse event, non-fatal
    1
    2
    2
         Withdrawal by Parent/Guardian
    1
    -
    1
         Lost to follow-up
    1
    -
    2
         COVID-19 impact
    -
    -
    1
         Protocol deviation
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Subjects received QD PF-04965842 at 200 mg, 100 mg or placebo for 12 weeks.

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 285 285
    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)
    		 1 1
        Adolescents (12-17 years)
    		 283 283
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        median (full range (min-max))
    		 15 (11 to 18) -
    Gender Categorical
    Units: Subjects
        Female
    		 140 140
        Male
    		 145 145
    Race
    Units: Subjects
        White
    		 160 160
        Black or African American
    		 17 17
        Asian
    		 94 94
        American Indian or Alaska Native
    		 8 8
        Native Hawaiian or Other Pacific Islander
    		 2 2
        Multiracial
    		 2 2
        Not reported
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    PF-04965842 100mg QD
    Reporting group description
    		 Subjects in this treatment group received PF-04965842 100 mg once daily (QD) for 12 weeks.

    Reporting group title
    PF-04965842 200mg QD
    Reporting group description
    		 Subjects in this treatment group received PF-04965842 200 mg QD for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects in this treatment group received PF-04965842-matching placebo QD for 12 weeks.

    Primary: Proportion of Subjects Achieving Investigator's Global Assessment (IGA) Response of "Clear" (0) or "Almost Clear" (1) and >=2 Points Improvement from Baseline at Week 12

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    End point title
    		 Proportion of Subjects Achieving Investigator's Global Assessment (IGA) Response of "Clear" (0) or "Almost Clear" (1) and >=2 Points Improvement from Baseline at Week 12
    End point description
    The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD were assessed according to a 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint were performed using the full analysis set (FAS) which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    89
    93
    94
    Units: Percent of total evaluable subjects
        number (confidence interval 95%)
    41.6 (31.3 to 51.8)
    46.2 (36.1 to 56.4)
    24.5 (15.8 to 33.2)
    Statistical analysis title
    		 PF-04965842 100 mg Versus Placebo
    Comparison groups
    PF-04965842 100mg QD v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0147 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    16.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.5
         upper limit
    		 29.9
    Notes
    [1] - Estimate of the difference in proportions of response was calculated by PF-04965842 100 mg minus placebo
    [2] - The significance level is 0.05.
    Statistical analysis title
    		 PF-04965842 200 mg Versus Placebo
    Comparison groups
    PF-04965842 200mg QD v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.003 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    20.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.3
         upper limit
    		 33.9
    Notes
    [3] - Estimate of the difference in proportions of response was calculated by PF-04965842 200 mg minus placebo
    [4] - The significance level is 0.05.

    Primary: Proportion of Subjects Achieving Eczema Area and Severity Index (EASI) Response >= 75% Improvement from Baseline at Week 12

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    End point title
    		 Proportion of Subjects Achieving Eczema Area and Severity Index (EASI) Response >= 75% Improvement from Baseline at Week 12
    End point description
    The EASI quantifies the severity of a subject’s AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    89
    93
    94
    Units: Percent of total evaluable subjects
        number (confidence interval 95%)
    68.5 (58.9 to 78.2)
    72.0 (62.9 to 81.2)
    41.5 (31.5 to 51.4)
    Statistical analysis title
    		 PF-04965842 100 mg Versus Placebo
    Comparison groups
    PF-04965842 100mg QD v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.0002 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    26.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.1
         upper limit
    		 39.8
    Notes
    [5] - Estimate of the difference in proportions of response was calculated by PF-04965842 100 mg minus placebo
    [6] - The significance level is 0.05.
    Statistical analysis title
    		 PF-04965842 200 mg Versus Placebo
    Comparison groups
    PF-04965842 200mg QD v Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.0001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    29.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.3
         upper limit
    		 42.5
    Notes
    [7] - Estimate of the difference in proportions of response was calculated by PF-04965842 200 mg minus placebo
    [8] - The significance level is 0.05.

    Secondary: Proportion of Subjects Achieving >=4 Points Improvement from Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12

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    End point title
    		 Proportion of Subjects Achieving >=4 Points Improvement from Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12
    End point description
    PP-NRS assesses the severity of itch (pruritus) due to AD. Subjects were asked to assess their worst itching due to AD on an NRS anchored by the terms “no itch” (0) and “worst itch imaginable” (10). Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of total evaluable subjects
    number (confidence interval 95%)
        Week 2
    27.2 (18.1 to 36.3)
    38.6 (28.5 to 48.8)
    12.6 (6.0 to 19.3)
        Week 4
    31.5 (21.8 to 41.1)
    50.0 (39.3 to 60.7)
    20.7 (12.4 to 28.9)
        Week 12
    52.6 (41.4 to 63.9)
    55.4 (44.1 to 66.7)
    29.8 (20.0 to 39.5)
    Statistical analysis title
    		 PF-04965842 100 mg Versus Palcebo at Week2
    Comparison groups
    PF-04965842 100mg QD v Placebo
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.0119 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    14.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.5
         upper limit
    		 25.9
    Notes
    [9] - Estimate of the difference in proportions of response was calculated by PF-04965842 100 mg minus placebo
    [10] - The significance level is 0.05.
    Statistical analysis title
    		 PF-04965842 200 mg Versus Placebo at Week 2
    Comparison groups
    PF-04965842 200mg QD v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 < 0.0001 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    26.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.9
         upper limit
    		 38.3
    Notes
    [11] - Estimate of the difference in proportions of response was calculated by PF-04965842 200 mg minus placebo
    [12] - The significance level is 0.05.
    Statistical analysis title
    		 PF-04965842 100 mg Versus Placebo at Week 4
    Comparison groups
    PF-04965842 100mg QD v Placebo
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.0971 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 23.6
    Notes
    [13] - Estimate of the difference in proportions of response was calculated by PF-04965842 100 mg minus placebo
    [14] - The significance level is 0.05.
    Statistical analysis title
    		 PF-04965842 200 mg Versus Placebo at Week 4
    Comparison groups
    PF-04965842 200mg QD v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 < 0.0001 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    29.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16
         upper limit
    		 42.9
    Notes
    [15] - Estimate of the difference in proportions of response was calculated by PF-04965842 200 mg minus placebo
    [16] - The significance level is 0.05.
    Statistical analysis title
    		 PF-04965842 100 mg Versus Placebo at Week 12
    Comparison groups
    PF-04965842 100mg QD v Placebo
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.0035 [18]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    22.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8
         upper limit
    		 37.7
    Notes
    [17] - Estimate of the difference in proportions of response was calculated by PF-04965842 100 mg minus placebo
    [18] - It is considered not statistically significant according to the sequential Bonferroni‑based iterative multiple testing procedure.
    Statistical analysis title
    		 PF-04965842 200 mg Versus Placebo at Week 12
    Comparison groups
    PF-04965842 200mg QD v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 = 0.0013 [20]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Estimate of difference
    Point estimate
    25.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.6
         upper limit
    		 40.6
    Notes
    [19] - Estimate of the difference in proportions of response was calculated by PF-04965842 200 mg minus placebo
    [20] - The significance level is 0.05.

    Secondary: Change from Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12

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    End point title
    		 Change from Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
    End point description
    The PSAAD is a 15 item questionnaire that includes 11 items developed to measure symptoms of AD based on a 24 hour recall. Four additional items were added for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). The analysis of this endpoint were performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    95
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -2.5 (-2.9 to -2.1)
    -2.7 (-3.1 to -2.3)
    -2.0 (-2.4 to -1.6)
    Statistical analysis title
    		 PF-04965842 100 mg Versus Placebo
    Comparison groups
    PF-04965842 100mg QD v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.0664 [22]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0
    Notes
    [21] - The least squares mean difference was calculated by PF-04965842 100 mg minus placebo.
    [22] - The significance level is 0.05.
    Statistical analysis title
    		 PF-04965842 200 mg Versus Placebo
    Comparison groups
    PF-04965842 200mg QD v Placebo
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 = 0.0142 [24]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.1
    Notes
    [23] - The least squares mean difference was calculated by PF-04965842 200 mg minus placebo.
    [24] - It is considered not statistically significant according to the sequential Bonferroni‑based iterative multiple testing procedure.

    Secondary: Proportion of Subjects Achieving IGA Response of 'Clear'(0) or 'Almost Clear'(1) and >=2 Points Improvement from Baseline at All Scheduled Time Points Except Week 12

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    End point title
    		 Proportion of Subjects Achieving IGA Response of 'Clear'(0) or 'Almost Clear'(1) and >=2 Points Improvement from Baseline at All Scheduled Time Points Except Week 12
    End point description
    The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD were assessed according to a 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint were performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and 8
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of total evaluable subjects
    number (confidence interval 95%)
        Week 2
    6.5 (1.5 to 11.6)
    12.8 (6.0 to 19.5)
    1.1 (0.0 to 3.2)
        Week 4
    19.6 (11.5 to 27.7)
    38.3 (28.5 to 48.1)
    3.1 (0.0 to 6.6)
        Week 8
    30.8 (21.3 to 40.3)
    48.9 (38.7 to 59.1)
    16.0 (8.6 to 23.4)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving EASI Response >= 75% Improvement from Baseline at All Scheduled Time Points Except Week 12

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    End point title
    		 Proportion of Subjects Achieving EASI Response >= 75% Improvement from Baseline at All Scheduled Time Points Except Week 12
    End point description
    The EASI quantifies the severity of a subject’s AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0 to 72.0, with higher scores representing greater severity of AD. Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4 and 8
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of total evaluable subjects
    number (confidence interval 95%)
        Week 2
    19.6 (11.5 to 27.7)
    25.5 (16.7 to 34.3)
    4.4 (0.2 to 8.6)
        Week 4
    41.3 (31.2 to 51.4)
    63.8 (54.1 to 73.5)
    14.6 (7.5 to 21.6)
        Week 8
    60.4 (50.4 to 70.5)
    68.5 (59.0 to 78.0)
    33.3 (23.8 to 42.9)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving EASI Response >= 50% Improvement from Baseline

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    End point title
    		 Proportion of Subjects Achieving EASI Response >= 50% Improvement from Baseline
    End point description
    The EASI quantifies the severity of a subject’s AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0 to 72.0, with higher scores representing greater severity of AD. Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of total evaluable subjects
    number (confidence interval 95%)
        Week 2
    55.4 (45.3 to 65.6)
    64.9 (55.2 to 74.5)
    24.2 (15.4 to 33.0)
        Week 4
    75.0 (66.2 to 83.8)
    81.9 (74.1 to 89.7)
    51.0 (41.0 to 61.0)
        Week 8
    85.7 (78.5 to 92.9)
    82.6 (74.9 to 90.4)
    65.6 (55.9 to 75.2)
        Week 12
    87.6 (80.8 to 94.5)
    87.1 (80.3 to 93.9)
    69.1 (59.8 to 78.5)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving EASI Response >= 90% Improvement from Baseline

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    End point title
    		 Proportion of Subjects Achieving EASI Response >= 90% Improvement from Baseline
    End point description
    The EASI quantifies the severity of a subject’s AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0 to 72.0, with higher scores representing greater severity of AD. Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of total evaluable subjects
    number (confidence interval 95%)
        Week 2
    8.7 (2.9 to 14.5)
    10.6 (4.4 to 16.9)
    0 (0.0 to 4.0)
        Week 4
    17.4 (9.6 to 25.1)
    30.9 (21.5 to 40.2)
    2.1 (0.0 to 4.9)
        Week 8
    29.7 (20.3 to 39.1)
    40.2 (30.2 to 50.2)
    14.0 (6.9 to 21.0)
        Week 12
    41.6 (31.3 to 51.8)
    49.5 (39.3 to 59.6)
    18.1 (10.3 to 25.9)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving EASI Response = 100% Improvement from Baseline

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    End point title
    		 Proportion of Subjects Achieving EASI Response = 100% Improvement from Baseline
    End point description
    The EASI quantifies the severity of a subject’s AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0 to 72.0, with higher scores representing greater severity of AD. Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of total evaluable subjects
    number (confidence interval 95%)
        Week 2
    1.1 (0.0 to 3.2)
    0 (0.0 to 3.8)
    0 (0.0 to 4.0)
        Week 4
    2.2 (0.0 to 5.2)
    5.3 (0.8 to 9.9)
    0 (0.0 to 3.8)
        Week 8
    3.3 (0.0 to 7.0)
    9.8 (3.7 to 15.9)
    0 (0.0 to 3.9)
        Week 12
    2.2 (0.0 to 5.3)
    8.6 (2.9 to 14.3)
    2.1 (0.0 to 5.0)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in EASI Score

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    End point title
    		 Percent Change from Baseline in EASI Score
    End point description
    The EASI quantifies the severity of a subject’s AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent change
    least squares mean (confidence interval 95%)
        Week 2
    -51.5 (-57.9 to -45.1)
    -54.5 (-61.0 to -48.0)
    -27.6 (-34.0 to -21.2)
        Week 4
    -66.1 (-72.7 to -59.4)
    -74.3 (-81.0 to -67.5)
    -41.7 (-48.3 to -35.1)
        Week 8
    -72.6 (-78.4 to -66.8)
    -77.8 (-83.7 to -71.9)
    -57.6 (-63.4 to -51.8)
        Week 12
    -77.3 (-83.1 to -71.5)
    -80.6 (-86.5 to -74.8)
    -63.7 (-69.5 to -57.9)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving >=4 Points Improvement from Baseline in PP-NRS or Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12

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    End point title
    		 Proportion of Subjects Achieving >=4 Points Improvement from Baseline in PP-NRS or Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12
    End point description
    PP-NRS assesses the severity of itch (pruritus) due to AD. Subjects were asked to assess their worst itching due to AD on an NRS anchored by the terms “no itch” (0) and “worst itch imaginable” (10). Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of total evaluable subjects
    number (confidence interval 95%)
        Day 2
    2.8 (0.0 to 6.7)
    3.9 (0.0 to 8.2)
    1.2 (0.0 to 3.6)
        Day 3
    5.1 (0.2 to 9.9)
    7.7 (1.8 to 13.6)
    0 (0.0 to 4.6)
        Day 4
    11.5 (4.4 to 18.6)
    14.3 (6.5 to 22.1)
    4.9 (0.2 to 9.7)
        Day 5
    12.2 (5.1 to 19.3)
    18.5 (10.1 to 27.0)
    6.9 (1.1 to 12.8)
        Day 6
    16.0 (8.1 to 24.0)
    21.3 (12.3 to 30.2)
    8.8 (2.6 to 14.9)
        Day 7
    16.0 (8.1 to 24.0)
    21.3 (12.3 to 30.2)
    10.1 (3.5 to 16.8)
        Day 8
    17.3 (8.8 to 25.9)
    25.0 (15.3 to 34.7)
    4.0 (0.0 to 8.4)
        Day 9
    16.0 (7.7 to 24.3)
    25.0 (15.5 to 34.5)
    6.0 (0.9 to 11.1)
        Day 10
    15.6 (7.5 to 23.7)
    28.8 (18.8 to 38.7)
    8.3 (2.4 to 14.2)
        Day 11
    20.8 (11.7 to 29.8)
    27.0 (16.9 to 37.1)
    7.6 (1.8 to 13.4)
        Day 12
    22.2 (12.6 to 31.8)
    23.6 (13.8 to 33.4)
    10.8 (3.7 to 17.9)
        Day 13
    26.3 (16.6 to 35.9)
    31.2 (20.8 to 41.5)
    10.0 (3.4 to 16.6)
        Day 14
    24.7 (15.3 to 34.1)
    32.4 (21.8 to 43.1)
    9.5 (3.2 to 15.8)
        Day 15
    27.7 (18.1 to 37.3)
    37.8 (27.3 to 48.3)
    14.3 (6.8 to 21.8)
    No statistical analyses for this end point

    Secondary: Time to First Achieve >=4 Points Improvement from Baseline in PP-NRS for Severity of Pruritus

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    End point title
    		 Time to First Achieve >=4 Points Improvement from Baseline in PP-NRS for Severity of Pruritus
    End point description
    PP-NRS assesses the severity of itch (pruritus) due to AD. Subjects were asked to assess their worst itching due to AD on an NRS anchored by the terms “no itch” (0) and “worst itch imaginable” (10). Subjects from FAS population with a baseline numeric rating scale score for severity of pruritus >=4 were included in the analysis. "99999" represents "non-evaluable" datum.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Days
        median (confidence interval 95%)
    70.0 (30.0 to 85.0)
    29.0 (15.0 to 61.0)
    90.0 (62.0 to 99999)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in PP-NRS for Severity of Pruritus

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    End point title
    		 Percent Change from Baseline in PP-NRS for Severity of Pruritus
    End point description
    PP-NRS assesses the severity of itch (pruritus) due to AD. Subjects were asked to assess their worst itching due to AD on an NRS anchored by the terms “no itch” (0) and “worst itch imaginable” (10). The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent Change
    least squares mean (confidence interval 95%)
        Day 2
    -9.5 (-14.2 to -4.8)
    -5.4 (-10.0 to -0.7)
    -0.9 (-5.5 to 3.6)
        Day 3
    -11.3 (-16.2 to -6.4)
    -10.2 (-15.2 to -5.2)
    -1.1 (-6.0 to 3.8)
        Day 4
    -14.6 (-20.2 to -9.1)
    -14.7 (-20.3 to -9.1)
    -5.0 (-10.6 to 0.5)
        Day 5
    -16.1 (-22.3 to -9.9)
    -17.6 (-23.9 to -11.3)
    -9.5 (-15.8 to -3.2)
        Day 6
    -18.5 (-25.0 to -12.1)
    -18.7 (-25.3 to -12.1)
    -8.7 (-15.2 to -2.2)
        Day 7
    -20.0 (-27.1 to -12.9)
    -18.8 (-26.0 to -11.6)
    -12.3 (-19.4 to -5.2)
        Day 8
    -21.6 (-28.9 to -14.2)
    -22.7 (-30.2 to -15.3)
    -10.6 (-17.9 to -3.3)
        Day 9
    -20.9 (-28.7 to -13.2)
    -21.7 (-29.5 to -13.9)
    -9.9 (-17.6 to -2.3)
        Day 10
    -26.1 (-33.1 to -19.0)
    -28.0 (-35.1 to -20.8)
    -10.8 (-17.8 to -3.8)
        Day 11
    -26.5 (-33.5 to -19.4)
    -26.3 (-33.5 to -19.1)
    -10.7 (-17.7 to -3.7)
        Day 12
    -27.0 (-34.0 to -20.0)
    -28.9 (-36.1 to -21.8)
    -11.0 (-18.0 to -4.0)
        Day 13
    -25.2 (-31.5 to -18.8)
    -32.5 (-39.0 to -26.0)
    -14.1 (-20.4 to -7.8)
        Day 14
    -29.4 (-35.5 to -23.2)
    -35.3 (-41.6 to -29.0)
    -12.0 (-18.1 to -5.8)
        Day 15
    -30.7 (-37.7 to -23.7)
    -33.4 (-40.5 to -26.3)
    -15.8 (-22.7 to -8.8)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Percentage Body Surface Area (BSA)

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    End point title
    		 Change from Baseline in Percentage Body Surface Area (BSA)
    End point description
    BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual subject for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible value was less than 100%. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8 and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    -21.0 (-24.1 to -17.9)
    -20.7 (-23.8 to -17.6)
    -10.9 (-14.0 to -7.8)
        Week 4
    -27.7 (-31.0 to -24.3)
    -32.6 (-36.0 to -29.1)
    -15.1 (-18.4 to -11.7)
        Week 8
    -32.6 (-36.1 to -29.1)
    -34.1 (-37.7 to -30.6)
    -21.8 (-25.3 to -18.3)
        Week 12
    -34.4 (-38.0 to -30.8)
    -35.2 (-38.8 to -31.6)
    -24.2 (-27.8 to -20.7)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Percentage BSA

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    End point title
    		 Percent Change from Baseline in Percentage BSA
    End point description
    BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual subject for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of atopic dermatitis. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible value was less than 100%. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent change
    least squares mean (confidence interval 95%)
        Week 2
    -40.4 (-46.5 to -34.3)
    -42.2 (-48.3 to -36.1)
    -20.6 (-26.7 to -14.5)
        Week 4
    -55.4 (-62.7 to -48.1)
    -66.0 (-73.4 to -58.6)
    -29.0 (-36.3 to -21.8)
        Week 8
    -65.7 (-72.4 to -59.1)
    -69.5 (-76.3 to -62.8)
    -46.0 (-52.6 to -39.3)
        Week 12
    -71.4 (-78.2 to -64.7)
    -72.6 (-79.3 to -65.8)
    -53.4 (-60.1 to -46.7)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Percentage BSA < 5% at Week 12

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    End point title
    		 Proportion of Subjects Achieving Percentage BSA < 5% at Week 12
    End point description
    BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual subject for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of atopic dermatitis. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible value was less than 100%. Subjects who withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    89
    93
    94
    Units: Percent of evaluable subjects
        number (confidence interval 95%)
    38.2 (28.1 to 48.3)
    36.6 (26.8 to 46.3)
    24.5 (15.8 to 33.2)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Scoring Atopic Dermatitis (SCORAD) Response >= 50% Improvement from Baseline

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    End point title
    		 Proportion of Subjects Achieving Scoring Atopic Dermatitis (SCORAD) Response >= 50% Improvement from Baseline
    End point description
    SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the subject using a NRS where “0” is no itch (or no sleeplessness) and “10” is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of evaluable subjects
    number (confidence interval 95%)
        Week 2
    22.6 (14.1 to 31.1)
    29.0 (19.8 to 38.3)
    8.6 (2.9 to 14.3)
        Week 4
    44.1 (34.0 to 54.2)
    64.1 (54.3 to 73.9)
    24.0 (15.4 to 32.5)
        Week 8
    65.6 (55.9 to 75.2)
    75.0 (66.2 to 83.8)
    34.0 (24.5 to 43.6)
        Week 12
    75.6 (66.7 to 84.4)
    73.9 (64.9 to 82.9)
    37.6 (27.8 to 47.5)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving SCORAD Response >= 75% Improvement from Baseline

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    End point title
    		 Proportion of Subjects Achieving SCORAD Response >= 75% Improvement from Baseline
    End point description
    SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject using a NRS where “0” is no itch (or no sleeplessness) and “10” is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of evaluable subjects
    number (confidence interval 95%)
        Week 2
    5.4 (0.8 to 10.0)
    7.5 (2.2 to 12.9)
    0 (0.0 to 3.9)
        Week 4
    11.8 (5.3 to 18.4)
    21.7 (13.3 to 30.2)
    0 (0.0 to 3.8)
        Week 8
    17.2 (9.5 to 24.9)
    33.7 (24.0 to 43.4)
    8.5 (2.9 to 14.2)
        Week 12
    36.7 (26.7 to 46.6)
    34.8 (25.1 to 44.5)
    12.9 (6.1 to 19.7)
    No statistical analyses for this end point

    Secondary: Change from Baseline in SCORAD Total Score

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    End point title
    		 Change from Baseline in SCORAD Total Score
    End point description
    SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject using a NRS where “0” is no itch (or no sleeplessness) and “10” is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    96
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    -24.6 (-27.7 to -21.6)
    -25.8 (-28.9 to -22.7)
    -12.3 (-15.4 to -9.2)
        Week 4
    -32.4 (-35.5 to -29.2)
    -38.0 (-41.2 to -34.8)
    -20.2 (-23.3 to -17.0)
        Week 8
    -37.3 (-40.7 to -33.9)
    -41.5 (-45.0 to -38.0)
    -26.6 (-30.0 to -23.2)
        Week 12
    -40.9 (-44.7 to -37.2)
    -42.9 (-46.7 to -39.1)
    -30.2 (-33.9 to -26.4)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in SCORAD Total Score

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    End point title
    		 Percent Change from Baseline in SCORAD Total Score
    End point description
    SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject using a NRS where “0” is no itch (or no sleeplessness) and “10” is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    96
    Units: Percent change
    least squares mean (confidence interval 95%)
        Week 2
    -36.1 (-40.6 to -31.7)
    -38.7 (-43.2 to -34.2)
    -18.7 (-23.1 to -14.2)
        Week 4
    -47.4 (-52.0 to -42.9)
    -56.9 (-61.6 to -52.3)
    -30.0 (-34.5 to -25.5)
        Week 8
    -54.0 (-59.0 to -48.9)
    -62.0 (-67.2 to -56.9)
    -39.9 (-44.9 to -34.8)
        Week 12
    -59.2 (-64.9 to -53.6)
    -64.3 (-70.1 to -58.6)
    -44.4 (-50.1 to -38.8)
    No statistical analyses for this end point

    Secondary: Change from Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss and Itch

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    End point title
    		 Change from Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss and Itch
    End point description
    SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the subject using a VAS where “0” is no itch (or no sleep loss) and “10” is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Change from baseline in SCORAD subjective assessments of itch was not evaluated. Only change from baseline in SCORAD subjective assessments of sleep loss is present below.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    96
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Sleep loss, Week 2
    -2.1 (-2.6 to -1.6)
    -2.6 (-3.1 to -2.1)
    -0.9 (-1.4 to -0.4)
        Sleep loss, Week 4
    -2.9 (-3.3 to -2.4)
    -3.4 (-3.9 to -2.9)
    -1.8 (-2.3 to -1.3)
        Sleep loss, Week 8
    -3.3 (-3.8 to -2.9)
    -3.7 (-4.2 to -3.2)
    -2.2 (-2.7 to -1.7)
        Sleep loss, Week 12
    -3.5 (-3.9 to -3.0)
    -3.9 (-4.4 to -3.4)
    -2.7 (-3.2 to -2.2)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in SCORAD Subjective VAS of Sleep Loss and Itch

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    End point title
    		 Percent Change from Baseline in SCORAD Subjective VAS of Sleep Loss and Itch
    End point description
    SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the subject using a VAS where “0” is no itch (or no sleep loss) and “10” is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Change from baseline in SCORAD subjective assessments of itch was not evaluated. Only change from baseline in SCORAD subjective assessments of sleep loss is present below.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    96
    Units: Percent change
    least squares mean (confidence interval 95%)
        Sleep loss, Week 2
    65.1 (-39.2 to 169.4)
    -36.5 (-140.7 to 67.8)
    2.6 (-101.2 to 106.3)
        Sleep loss, Week 4
    -35.2 (-50.7 to -19.8)
    -53.4 (-69.1 to -37.8)
    -20.0 (-35.2 to -4.9)
        Sleep loss, Week 8
    -44.2 (-79.9 to -8.5)
    -30.6 (-66.7 to 5.5)
    -24.7 (-60.1 to 10.8)
        Sleep loss, Week 12
    -49.8 (-88.3 to -11.3)
    -35.2 (-74.1 to 3.7)
    -39.5 (-77.7 to -1.3)
    No statistical analyses for this end point

    Secondary: Number of Days When a Corticosteroid Not Used up to Day 88

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    End point title
    		 Number of Days When a Corticosteroid Not Used up to Day 88
    End point description
    The analysis include all randomized subjects who received at least one dose of study medication and had used corticosteroid during treatment period
    End point type
    Secondary
    End point timeframe
    Baseline to Day 88
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    89
    82
    83
    Units: Days
        least squares mean (confidence interval 95%)
    10.9 (6.2 to 15.5)
    15.1 (10.2 to 19.9)
    6.8 (2.0 to 11.6)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Children's Dermatology Life Quality Index (DLQI)

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    End point title
    		 Change from Baseline in Children's Dermatology Life Quality Index (DLQI)
    End point description
    The DLQI is a general dermatology questionnaire that consists of 10 items to assess subject-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Subjects who were withdrew from the study were counted as non-responder. This endpoint's analysis included all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    -6.1 (-7.1 to -5.2)
    -6.3 (-7.2 to -5.3)
    -4.2 (-5.1 to -3.3)
        Week 4
    -7.3 (-8.2 to -6.4)
    -7.6 (-8.6 to -6.7)
    -5.4 (-6.3 to -4.5)
        Week 8
    -8.1 (-9.1 to -7.1)
    -8.2 (-9.2 to -7.2)
    -6.1 (-7.0 to -5.1)
        Week 12
    -8.6 (-9.6 to -7.5)
    -8.7 (-9.7 to -7.6)
    -6.3 (-7.4 to -5.3)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects with >=2.5 Points at Baseline and Achieving >=2.5 Points Improvement from Baseline in Children's DLQI

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    End point title
    		 Proportion of Subjects with >=2.5 Points at Baseline and Achieving >=2.5 Points Improvement from Baseline in Children's DLQI
    End point description
    The DLQI is a general dermatology questionnaire that consists of 10 items to assess subject-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Subjects who were withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of evaluable subjects
    number (confidence interval 95%)
        Week 2
    73.6 (64.6 to 82.7)
    71.3 (62.1 to 80.4)
    61.5 (51.5 to 71.5)
        Week 4
    82.4 (74.6 to 90.2)
    73.4 (64.5 to 82.3)
    73.7 (64.8 to 82.5)
        Week 8
    85.9 (78.8 to 93.0)
    79.6 (71.4 to 87.8)
    71.0 (61.7 to 80.2)
        Week 12
    80.9 (72.7 to 89.1)
    78.5 (70.1 to 86.8)
    67.7 (58.2 to 77.2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)

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    End point title
    		 Change from Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)
    End point description
    The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    -1.6 (-2.1 to -1.1)
    -1.3 (-1.8 to -0.8)
    -1.2 (-1.7 to -0.7)
        Week 4
    -1.6 (-2.2 to -1.1)
    -1.9 (-2.5 to -1.3)
    -1.5 (-2.1 to -1.0)
        Week 8
    -2.1 (-2.7 to -1.5)
    -2.2 (-2.8 to -1.5)
    -1.7 (-2.3 to -1.1)
        Week 12
    -2.0 (-2.6 to -1.4)
    -2.4 (-3.0 to -1.8)
    -2.1 (-2.7 to -1.5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Depression of HADS

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    End point title
    		 Change from Baseline in Depression of HADS
    End point description
    The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome. The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    -1.2 (-1.7 to -0.8)
    -0.8 (-1.3 to -0.3)
    -0.8 (-1.3 to -0.3)
        Week 4
    -1.3 (-1.8 to -0.8)
    -1.3 (-1.8 to -0.8)
    -0.8 (-1.3 to -0.3)
        Week 8
    -1.4 (-1.9 to -0.9)
    -1.2 (-1.7 to -0.7)
    -1.1 (-1.6 to -0.6)
        Week 12
    -1.4 (-1.9 to -0.8)
    -1.2 (-1.7 to -0.6)
    -1.0 (-1.5 to -0.5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Patient-Oriented Eczema Measure (POEM)

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    End point title
    		 Change from Baseline in Patient-Oriented Eczema Measure (POEM)
    End point description
    The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "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. The higher values represent more severe AD. The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    95
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    -6.9 (-8.2 to -5.6)
    -8.2 (-9.5 to -6.9)
    -3.4 (-4.7 to -2.1)
        Week 4
    -9.5 (-10.7 to -8.3)
    -10.6 (-11.9 to -9.4)
    -4.8 (-6.0 to -3.6)
        Week 8
    -10.0 (-11.4 to -8.7)
    -10.6 (-12.0 to -9.3)
    -5.4 (-6.7 to -4.0)
        Week 12
    -11.1 (-12.5 to -9.7)
    -10.9 (-12.2 to -9.5)
    -6.9 (-8.3 to -5.6)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Dermatitis Family Impact (DFI) at Week 12

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    End point title
    		 Change from Baseline in Dermatitis Family Impact (DFI) at Week 12
    End point description
    The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient’s eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact. The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    92
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    -4.2 (-5.2 to -3.1)
    -5.2 (-6.2 to -4.1)
    -2.7 (-3.7 to -1.6)
        Week 4
    -5.7 (-6.7 to -4.6)
    -5.9 (-7.0 to -4.9)
    -4.8 (-5.8 to -3.7)
        Week 8
    -6.8 (-7.9 to -5.7)
    -7.3 (-8.5 to -6.2)
    -5.1 (-6.3 to -4.0)
        Week 12
    -6.7 (-7.9 to -5.4)
    -7.3 (-8.6 to -6.0)
    -5.2 (-6.5 to -3.9)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Patient Global Assessment (PtGA)

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    End point title
    		 Change from Baseline in Patient Global Assessment (PtGA)
    End point description
    The PtGA asked the subject to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    -0.7 (-0.9 to -0.6)
    -1.0 (-1.1 to -0.8)
    -0.4 (-0.6 to -0.3)
        Week 4
    -0.9 (-1.1 to -0.8)
    -1.2 (-1.4 to -1.1)
    -0.7 (-0.8 to -0.5)
        Week 8
    -1.2 (-1.3 to -1.0)
    -1.4 (-1.6 to -1.2)
    -0.8 (-1.0 to -0.6)
        Week 12
    -1.4 (-1.6 to -1.2)
    -1.6 (-1.8 to -1.4)
    -0.9 (-1.1 to -0.7)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects with >=2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement from Baseline in PtGA

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    End point title
    		 Proportion of Subjects with >=2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement from Baseline in PtGA
    End point description
    The PtGA asked the subject to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities. Subjects who were withdrew from the study were counted as non-responder. The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Percent of evaluable subjects
    number (confidence interval 95%)
        Week 2
    5.4 (0.8 to 10.1)
    5.3 (0.8 to 9.9)
    1.1 (0.0 to 3.2)
        Week 4
    14.1 (7.0 to 21.2)
    20.2 (12.1 to 28.3)
    4.2 (0.2 to 8.2)
        Week 8
    22.6 (14.1 to 31.1)
    26.9 (17.9 to 35.9)
    6.4 (1.4 to 11.3)
        Week 12
    30.0 (20.5 to 39.5)
    36.6 (26.8 to 46.3)
    10.6 (4.4 to 16.9)
    No statistical analyses for this end point

    Secondary: Change from Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score

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    End point title
    		 Change from Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score
    End point description
    The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale ranges from 1 (minimum) to 3 (maximum). Higher scores indicates worse health condition. The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Week 2
    11.241 (7.882 to 14.601)
    12.141 (8.763 to 15.520)
    7.140 (3.787 to 10.492)
        Week 4
    13.222 (10.020 to 16.423)
    14.677 (11.438 to 17.917)
    8.784 (5.625 to 11.943)
        Week 8
    14.502 (10.977 to 18.028)
    14.653 (11.076 to 18.231)
    8.415 (4.888 to 11.941)
        Week 12
    14.226 (10.624 to 17.828)
    15.756 (12.153 to 19.360)
    9.944 (6.373 to 13.515)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F)

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    End point title
    		 Change from Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F)
    End point description
    The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT–F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). The analysis of this endpoint was performed using the FAS which was defined as all randomized subjects who took at least 1 dose of study intervention. Change from baseline at Week 12 is present below. Change from baseline at other scheduled time points were not evaluated.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    4.5 (3.0 to 5.9)
    4.3 (2.9 to 5.7)
    2.5 (1.1 to 3.9)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. The safety analysis population included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Subjects
        All-causality AEs
    54
    59
    50
        Treatment-related AEs
    20
    31
    16
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs)
    End point description
    A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.Treatment-related SAEs were determined by the investigator. The safety analysis population included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Subjects
        All-causality SAEs
    0
    1
    2
        Treatment-related SAEs
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Discontinued From the Study Due to TEAEs

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    End point title
    		 Number of Subjects Who Discontinued From the Study Due to TEAEs
    End point description
    An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. The safety analysis population included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    94
    96
    Units: Subjects
        All-causality TEAEs
    1
    2
    2
        Treatment-related TEAEs
    0
    2
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Test Abnormalities (Without Regard to Baseline)

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    End point title
    		 Number of Subjects With Laboratory Test Abnormalities (Without Regard to Baseline)
    End point description
    Laboratory tests included hematology (including coagulation panel), chemistry, lipid profiles, and urinalysis. The safety analysis population included all subjects who received at least 1 dose of study medication. LLN is lower limit of normal, ULN is upper limit of normal..
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    96
    Units: Subjects
        Hb (g/dL) <0.8*LLN
    0
    0
    0
        Hematocrit (%) <0.8*LLN
    0
    0
    0
        Erythrocytes (10^6/mm^3) <0.8*LLN
    0
    0
    0
        Reticulocytes (10^3/mm^3) <0.5*LLN
    0
    0
    0
        Reticulocytes (10^3/mm^3) >1.5*ULN
    0
    0
    0
        Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN
    1
    0
    1
        Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN
    0
    0
    0
        Ery. Mean Corpuscular Hb (pg/cell) <0.9*LLN
    1
    0
    1
        Ery. Mean Corpuscular Hb (pg/cell) >1.1*ULN
    0
    0
    0
        Ery. Mean Corpuscular Hb Conc. (g/dL) <0.9*LLN
    0
    0
    0
        Ery. Mean Corpuscular Hb Conc. (g/dL)>1.1*ULN
    0
    0
    0
        Platelets (10^3/mm^3) <0.5*LLN
    0
    0
    1
        Platelets (10^3/mm^3) >1.75*ULN
    0
    0
    0
        Reticulocytes/Erythrocytes (%) <0.5*LLN
    0
    0
    0
        Reticulocytes/Erythrocytes (%) >1.5*ULN
    0
    1
    0
        Leukocytes (10^3/mm^3) <0.6*LLN
    0
    0
    0
        Leukocytes (10^3/mm^3) >1.5*ULN
    0
    0
    1
        Lymphocytes (10^3/mm^3) <0.8*LLN
    0
    1
    0
        Lymphocytes (10^3/mm^3) >1.2*ULN
    0
    1
    0
        Lymphocytes/Leukocytes (%) <0.8*LLN
    4
    6
    6
        Lymphocytes/Leukocytes (%)>1.2*ULN
    1
    4
    1
        Neutrophils (10^3/mm^3) <0.8*LLN
    2
    1
    1
        Neutrophils (10^3/mm^3) >1.2*ULN
    5
    3
    6
        Neutrophils/Leukocytes (%) <0.8*LLN
    3
    7
    5
        Neutrophils/Leukocytes (%) >1.2*ULN
    0
    0
    0
        Basophils (10^3/mm^3) >1.2*ULN
    0
    0
    3
        Basophils/Leukocytes (%) >1.2*ULN
    24
    27
    35
        Eosinophils (10^3/mm^3) >1.2*ULN
    55
    39
    63
        Eosinophils/Leukocytes (%) >1.2*ULN
    62
    47
    61
        Monocytes (10^3/mm^3)>1.2*ULN
    0
    0
    1
        Monocytes/Leukocytes (%) >1.2*ULN
    11
    6
    7
        Partial Thromboplastin Time (sec) >1.1*ULN
    4
    4
    2
        Prothrombin Time (sec) >1.1*ULN
    6
    8
    4
        Prothrombin Intl. Normalized Ratio >1.1*ULN
    0
    0
    0
        Bilirubin (mg/dL) >1.5*ULN
    4
    0
    1
        Direct Bilirubin (mg/dL) >1.5*ULN
    0
    0
    0
        Indirect Bilirubin (mg/dL) >1.5*ULN
    2
    0
    1
        Aspartate Aminotransferase (U/L) >3.0*ULN
    1
    3
    1
        Alanine Aminotransferase (U/L) >3.0*ULN
    3
    1
    0
        Gamma Glutamyl Transferase(U/L) >3.0*ULN
    0
    0
    1
        Lactate Dehydrogenase (U/L) >3.0*ULN
    1
    2
    0
        Alkaline Phosphatase (U/L) >3.0*ULN
    0
    1
    0
        Protein (g/dL) <0.8*LLN
    0
    0
    0
        Protein (g/dL) >1.2*ULN
    0
    1
    0
        Albumin (g/dL) <0.8*LLN
    0
    0
    0
        Albumin (g/dL) >1.2*ULN
    0
    3
    0
        Urea Nitrogen (mg/dL) >1.3*ULN
    0
    0
    0
        Creatine (mg/dL) >1.3*ULN
    2
    0
    3
        Urate (mg/dL) >1.2*ULN
    4
    1
    2
        LDL Cholesterol (mg/dL) >1.2*ULN
    2
    3
    2
        Triglycerides (mg/dL) >1.3*ULN
    11
    13
    17
        Sodium (mEq/L) <0.95*LLN
    0
    0
    0
        Sodium (mEq/L) >1.05*ULN
    0
    0
    0
        Potassium (mEq/L) <0.9*LLN
    0
    0
    0
        Potassium (mEq/L)>1.1*ULN
    0
    0
    1
        Chloride (mEq/L) <0.9*LLN
    0
    0
    0
        Chloride (mEq/L) >1.1*ULN
    0
    0
    0
        Calcium (mEq/L) <0.9*LLN
    0
    0
    0
        Calcium (mEq/L) >1.1*ULN
    0
    0
    0
        Bicarbonate (mEq/L) <0.9*LLN
    1
    0
    1
        Bicarbonate (mEq/L) >1.1*ULN
    0
    0
    0
        Glucose (mg/dL) <0.6*LLN
    0
    0
    0
        Glucose (mg/dL) >1.5*ULN
    2
    3
    0
        Creatine Kinase (U/L) >2.0*ULN
    7
    12
    5
        Cholesterol (mg/dL) >1.3*ULN
    2
    2
    2
        HDL Cholesterol (mg/dL) <0.8*LLN
    0
    0
    0
        Urine Specific Gravity (scalar) <1.003
    0
    0
    0
        Urine Specific Gravity (scalar) >1.030
    1
    0
    0
        Urine pH (scalar) <4.5
    0
    0
    0
        Urine pH (scalar) >8
    1
    0
    0
        Urine Glucose >=1
    0
    0
    1
        Urine Ketones >=1
    0
    1
    8
        Urine Protein >=1
    5
    0
    4
        Urine Hemoglobin >=1
    19
    15
    20
        Urine Nitrite >=1
    1
    0
    0
        Urine Leukocyte Esterase >=1
    14
    17
    7
        Urine Erythrocytes (/HPF) >=20
    7
    5
    8
        Urine Leukocytes (/HPF) >=20
    2
    1
    0
        Granular Casts (/LPF) >1
    0
    0
    1
        Hyaline Casts (/LPF) >1
    1
    1
    2
        Urine Bacteria >20
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subject with Electrocardiogram (ECG) Data Meeting Pre-specified Criteria

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    End point title
    		 Number of Subject with Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
    End point description
    A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the subject had rested quietly for at least 10 minutes in a supine position. The endpoint's analysis included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    96
    Units: Subjects
        QTcF interval>500 msec
    0
    0
    0
        Change from Screening in QTcF >60 msec
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Categoriztion of Vital Signs Data Meeting Prespecified Criteria

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    End point title
    		 Categoriztion of Vital Signs Data Meeting Prespecified Criteria
    End point description
    Vital signs (pulse rate, systolic and diastolic blood pressure [BP]) were obtained with subject in the seated position, after having sat calmly for at least 5 minutes. The endpoint's analysis included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    95
    93
    96
    Units: Subjects
        Diastolic BP <50 mmHg
    1
    9
    3
        Diastolic BR increase from baseline >= 20 mmHg
    6
    6
    3
        Diastolic BR decrease from baseline >= 20 mmHg
    4
    8
    3
        Pulse Rate <40 bpm
    0
    0
    0
        Pulse Rate >120 bpm
    0
    0
    0
        Systolic BP <90 mmHg
    7
    4
    4
        Systolic BR increase from baseline >= 30 mmHg
    1
    2
    2
        Systolic BR decrease from baseline >= 30 mmHg
    1
    2
    2
    No statistical analyses for this end point

    Secondary: Fold Increase of Immunoglobulin G (IgG) Concentrations against Specific Vaccine Antigens at 4 Weeks Post-Vaccination

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    End point title
    		 Fold Increase of Immunoglobulin G (IgG) Concentrations against Specific Vaccine Antigens at 4 Weeks Post-Vaccination
    End point description
    The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent subjects 12 to <18 years of age with moderate to severe AD. Subjects who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. Immunogenicity analysis set was defined as subjects who had completed 8 weeks of treatment and after Tdap vaccination. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below and it was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD Placebo
    Number of subjects analysed
    9
    6
    10
    Units: Ratio
    geometric mean (confidence interval 95%)
        Diphtheria IgG Antibody
    6.51 (2.31 to 18.34)
    34.61 (6.96 to 172.06)
    14.00 (6.32 to 30.99)
        Filamentous Hemagglutinin IgG
    11.48 (2.65 to 49.69)
    22.77 (7.26 to 71.45)
    15.19 (4.89 to 47.16)
        Fimbriae 2/3 IgG
    1.11 (0.85 to 1.46)
    1.47 (0.61 to 3.50)
    1.93 (0.79 to 4.73)
        Pertactin IgG
    15.60 (5.77 to 42.14)
    60.18 (12.79 to 283.08)
    54.03 (14.67 to 199.03)
        Pertussis Toxin IgG
    10.17 (4.71 to 21.94)
    33.16 (5.04 to 218.38)
    6.94 (1.95 to 24.71)
        Tetanus Toxoid IgG Antibody
    16.26 (3.52 to 75.11)
    48.41 (9.01 to 260.09)
    8.36 (1.62 to 43.18)
    No statistical analyses for this end point

    Secondary: Plasma PF-04965842 Concentration at Week 8

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    End point title
    		 Plasma PF-04965842 Concentration at Week 8 [25]
    End point description
    End point type
    Secondary
    End point timeframe
    2 hours before Week 8 visit dose
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    72
    62
    Units: ng/mL
        arithmetic mean (standard deviation)
    7.882 ( 26.350 )
    32.33 ( 76.506 )
    No statistical analyses for this end point

    Secondary: Plasma PF-04965842 Concentration at Week 12

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    End point title
    		 Plasma PF-04965842 Concentration at Week 12 [26]
    End point description
    End point type
    Secondary
    End point timeframe
    2 hours post Week 12 visit dosing
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    59
    50
    Units: ng/mL
        arithmetic mean (standard deviation)
    486.6 ( 403.69 )
    1271 ( 1000.4 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16 weeks
    Adverse event reporting additional description
    The same event may appear as both an AE and an SAE. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of subjects evaluable for SAEs or AEs.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    PF-04965842 100 mg QD
    Reporting group description
    		 -

    Reporting group title
    PF-04965842 200 mg QD
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 PF-04965842 100 mg QD PF-04965842 200 mg QD Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 94 (1.06%)
    2 / 96 (2.08%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 94 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis atopic
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 94 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 94 (1.06%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 PF-04965842 100 mg QD PF-04965842 200 mg QD Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 95 (56.84%)
    59 / 94 (62.77%)
    49 / 96 (51.04%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    4 / 95 (4.21%)
    4 / 94 (4.26%)
    0 / 96 (0.00%)
         occurrences all number
    5
    4
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 95 (1.05%)
    2 / 94 (2.13%)
    0 / 96 (0.00%)
         occurrences all number
    1
    2
    0
    Blood uric acid increased
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 94 (0.00%)
    2 / 96 (2.08%)
         occurrences all number
    1
    0
    2
    Haemoglobin increased
         subjects affected / exposed
    0 / 95 (0.00%)
    2 / 94 (2.13%)
    0 / 96 (0.00%)
         occurrences all number
    0
    3
    0
    Protein urine
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 94 (0.00%)
    2 / 96 (2.08%)
         occurrences all number
    1
    0
    2
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 94 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 95 (0.00%)
    6 / 94 (6.38%)
    1 / 96 (1.04%)
         occurrences all number
    0
    9
    2
    Headache
         subjects affected / exposed
    5 / 95 (5.26%)
    8 / 94 (8.51%)
    7 / 96 (7.29%)
         occurrences all number
    7
    12
    8
    Somnolence
         subjects affected / exposed
    0 / 95 (0.00%)
    2 / 94 (2.13%)
    2 / 96 (2.08%)
         occurrences all number
    0
    2
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 94 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    2
    0
    1
    Pyrexia
         subjects affected / exposed
    3 / 95 (3.16%)
    1 / 94 (1.06%)
    4 / 96 (4.17%)
         occurrences all number
    3
    1
    4
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 94 (0.00%)
    2 / 96 (2.08%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 95 (1.05%)
    3 / 94 (3.19%)
    1 / 96 (1.04%)
         occurrences all number
    1
    3
    1
    Diarrhoea
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 94 (1.06%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Lip swelling
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 94 (0.00%)
    2 / 96 (2.08%)
         occurrences all number
    0
    0
    2
    Nausea
         subjects affected / exposed
    7 / 95 (7.37%)
    17 / 94 (18.09%)
    1 / 96 (1.04%)
         occurrences all number
    7
    27
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 95 (0.00%)
    4 / 94 (4.26%)
    0 / 96 (0.00%)
         occurrences all number
    0
    5
    0
    Vomiting
         subjects affected / exposed
    4 / 95 (4.21%)
    5 / 94 (5.32%)
    0 / 96 (0.00%)
         occurrences all number
    4
    7
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 94 (1.06%)
    2 / 96 (2.08%)
         occurrences all number
    1
    3
    2
    Cough
         subjects affected / exposed
    4 / 95 (4.21%)
    1 / 94 (1.06%)
    2 / 96 (2.08%)
         occurrences all number
    6
    1
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 94 (0.00%)
    3 / 96 (3.13%)
         occurrences all number
    1
    0
    4
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 95 (3.16%)
    5 / 94 (5.32%)
    1 / 96 (1.04%)
         occurrences all number
    3
    5
    2
    Dermatitis atopic
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 94 (1.06%)
    2 / 96 (2.08%)
         occurrences all number
    2
    2
    2
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    7 / 95 (7.37%)
    2 / 94 (2.13%)
    1 / 96 (1.04%)
         occurrences all number
    7
    2
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 95 (2.11%)
    2 / 94 (2.13%)
    1 / 96 (1.04%)
         occurrences all number
    2
    2
    1
    Hordeolum
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 94 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Influenza
         subjects affected / exposed
    4 / 95 (4.21%)
    2 / 94 (2.13%)
    1 / 96 (1.04%)
         occurrences all number
    4
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    8 / 95 (8.42%)
    8 / 94 (8.51%)
    9 / 96 (9.38%)
         occurrences all number
    10
    9
    11
    Oral herpes
         subjects affected / exposed
    1 / 95 (1.05%)
    2 / 94 (2.13%)
    0 / 96 (0.00%)
         occurrences all number
    2
    2
    0
    Pharyngitis
         subjects affected / exposed
    5 / 95 (5.26%)
    3 / 94 (3.19%)
    3 / 96 (3.13%)
         occurrences all number
    5
    3
    3
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 94 (0.00%)
    2 / 96 (2.08%)
         occurrences all number
    0
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 95 (0.00%)
    3 / 94 (3.19%)
    0 / 96 (0.00%)
         occurrences all number
    0
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 95 (9.47%)
    10 / 94 (10.64%)
    10 / 96 (10.42%)
         occurrences all number
    11
    14
    12

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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