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    Clinical Trial Results:
    A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Parallel, Multicenter, Dose-Ranging, Study to Evaluate the Efficacy and Safety Profile of PF-04965842 in Subjects With Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2015-005513-72
    Trial protocol
    		 DE   HU  
    Global end of trial date
    04 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2018
    First version publication date
    11 Mar 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B7451006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02780167
    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, Inc, Pfizer Clinical Trials.gov Call Center, +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
    25 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of 4 once daily (QD) dose levels (10, 30, 100 and 200 mg) of PF-04965842 relative to placebo in adult subjects with moderate to severe atopic dermatitis (AD), using the Investigator's Global Assessment (IGA).
    Protection of trial subjects
    This study used an Internal Review Committee (IRC) to monitor the safety of the subjects throughout the study and to make recommendations to the study team. Composition of the IRC and processes under which the IRC operated were documented in an IRC charter.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 49
    Country: Number of subjects enrolled
    Canada: 68
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    United States: 123
    Worldwide total number of subjects
    267
    EEA total number of subjects
    27
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    239
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 269 subjects were randomized. There were 2 subjects who were randomized but did not receive any study treatment. A total of 267 subjects were randomized and treated.

    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
    		 Placebo
    Arm description
    		 Treatment Group Description
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 mg

    Arm title
    		 PF-04965842 10mg QD
    Arm description
    		 Treatment Group Description
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg

    Arm title
    		 PF-04965842 30mg QD
    Arm description
    		 Treatment Group Description
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg

    Arm title
    		 PF-04965842 100mg QD
    Arm description
    		 Treatment Group Description
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg

    Arm title
    		 PF-04965842 200mg QD
    Arm description
    		 Treatment Group Description
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04965842
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg

    Number of subjects in period 1
    		Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Started
    56
    49
    51
    56
    55
    Completed
    28
    27
    27
    37
    38
    Not completed
    28
    22
    24
    19
    17
         Consent withdrawn by subject
    6
    4
    4
    3
    4
         Does not meet entrance criteria
    -
    -
    1
    -
    -
         Adverse event, non-fatal
    9
    8
    8
    12
    8
         No longer meets eligibility criteria
    -
    -
    -
    1
    1
         Unspecified
    -
    -
    3
    1
    2
         Lost to follow-up
    2
    -
    1
    -
    -
         Lack of efficacy
    6
    5
    6
    1
    -
         Protocol deviation
    5
    5
    1
    1
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Treatment Group Description

    Reporting group title
    PF-04965842 10mg QD
    Reporting group description
    		 Treatment Group Description

    Reporting group title
    PF-04965842 30mg QD
    Reporting group description
    		 Treatment Group Description

    Reporting group title
    PF-04965842 100mg QD
    Reporting group description
    		 Treatment Group Description

    Reporting group title
    PF-04965842 200mg QD
    Reporting group description
    		 Treatment Group Description

    Reporting group values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD Total
    Number of subjects
    		 56 49 51 56 55 267
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 51 44 48 49 47 239
        From 65-84 years
    		 5 5 3 7 8 28
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.6 ± 15.1 44.3 ± 15.9 37.6 ± 15.9 41.1 ± 15.6 38.7 ± 17.6 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 35 28 29 25 27 144
        Male
    		 21 21 22 31 28 123
    Race/Ethnicity
    Units: Subjects
        White
    		 40 38 39 40 37 194
        Black
    		 10 5 4 7 13 39
        Asian
    		 4 5 5 8 5 27
        Other
    		 2 1 3 1 0 7

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Treatment Group Description

    Reporting group title
    PF-04965842 10mg QD
    Reporting group description
    		 Treatment Group Description

    Reporting group title
    PF-04965842 30mg QD
    Reporting group description
    		 Treatment Group Description

    Reporting group title
    PF-04965842 100mg QD
    Reporting group description
    		 Treatment Group Description

    Reporting group title
    PF-04965842 200mg QD
    Reporting group description
    		 Treatment Group Description

    Primary: Percentage of subjects achieving the Investigator's Global Assessment (IGA) for clear (0) or almost clear (1) and >=2 points improvement from baseline at Week 12

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    End point title
    		 Percentage of subjects achieving the Investigator's Global Assessment (IGA) for clear (0) or almost clear (1) and >=2 points improvement from baseline at Week 12
    End point description
    The IGA score quantifies the severity of subjects' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    52 [1]
    46
    45
    54
    48
    Units: percentage of subjects
        least squares mean (standard error)
    6.3 ± 2.55
    8.2 ± 2.32
    12.3 ± 2.88
    27.8 ± 5.07
    44.5 ± 6.92
    Notes
    [1] - "Number of Subjects Analyzed" represents the number of evaluable subjects at Week 12.
    Statistical analysis title
    		 Treatment difference (PF-04965842 10 mg/placebo)
    Comparison groups
    Placebo v PF-04965842 10mg QD
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.121
    Method
    		 Emax model
    Parameter type
    		 Difference
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 4.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.99
    Statistical analysis title
    		 Treatment difference (PF-04965842 30 mg/placebo)
    Comparison groups
    Placebo v PF-04965842 30mg QD
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1065
    Method
    		 Emax model
    Parameter type
    		 Difference
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 13.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.05
    Statistical analysis title
    		 Treatment difference (PF-04965842 100 mg/placebo)
    Comparison groups
    Placebo v PF-04965842 100mg QD
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0184
    Method
    		 Emax model
    Parameter type
    		 Difference
    Point estimate
    21.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.5
         upper limit
    		 37.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.25
    Statistical analysis title
    		 Treatment difference (PF-04965842 200 mg/placebo)
    Comparison groups
    Placebo v PF-04965842 200mg QD
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0032
    Method
    		 Emax model
    Parameter type
    		 Difference
    Point estimate
    38.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.7
         upper limit
    		 56.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.18

    Secondary: Percent change from baseline in the eczema area and severity index (EASI) at Week 12

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    End point title
    		 Percent change from baseline in the eczema area and severity index (EASI) at Week 12
    End point description
    The EASI quantifies the severity of subjects' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of four regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. 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.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    35 [2]
    29
    30
    43
    42
    Units: percent change
        least squares mean (standard error)
    -35.22 ± 6.572
    -31.13 ± 7.090
    -40.73 ± 6.823
    -59.04 ± 6.212
    -82.57 ± 6.161
    Notes
    [2] - "Number of Subjects Analyzed" represents the number of evaluable subjects at Week 12.
    Statistical analysis title
    		 Treatment difference (PF-04965842 10 mg/placebo)
    Comparison groups
    Placebo v PF-04965842 10mg QD
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6731
    Method
    		 Mixed-Effect Model Repeated Measures
    Parameter type
    		 Difference
    Point estimate
    4.08
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -11.88
         upper limit
    		 20.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.667
    Statistical analysis title
    		 Treatment difference (PF-04965842 30 mg/placebo)
    Comparison groups
    Placebo v PF-04965842 30mg QD
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.561
    Method
    		 Mixed-Effect Model Repeated Measures
    Parameter type
    		 Difference
    Point estimate
    -5.52
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -21.16
         upper limit
    		 10.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.474
    Statistical analysis title
    		 Treatment difference (PF-04965842 100 mg/placebo)
    Comparison groups
    Placebo v PF-04965842 100mg QD
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0091
    Method
    		 Mixed-Effect Model Repeated Measures
    Parameter type
    		 Difference
    Point estimate
    -23.82
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -38.76
         upper limit
    		 -8.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.043
    Statistical analysis title
    		 Treatment difference (PF-04965842 200 mg/placebo)
    Comparison groups
    Placebo v PF-04965842 200mg QD
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Mixed-Effect Model Repeated Measures
    Parameter type
    		 Difference
    Point estimate
    -47.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -62.23
         upper limit
    		 -32.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.008

    Secondary: Percentage of subjects achieving the IGA for 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
    		 Percentage of subjects achieving the IGA for 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 score quantifies the severity of subjects' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [3]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Week 1 (n = 54, 48, 50, 55, 54)
    0.0
    2.1
    2.0
    1.8
    3.7
        Week 2 (n = 55, 49, 50, 55, 52)
    3.6
    6.1
    6.0
    3.6
    11.5
        Week 4 (n = 55, 49, 50, 55, 54)
    1.8
    8.2
    8.0
    16.4
    40.7
        Week 6 (n = 55, 49, 50, 55, 54)
    14.5
    14.3
    14.0
    12.7
    40.7
        Week 8 (n = 55, 49, 50, 55, 53)
    5.5
    8.2
    12.0
    16.4
    41.5
        Week 13 (n= 30, 29, 31, 38, 45)
    10.0
    20.7
    12.9
    23.7
    26.7
        Week 14 (n = 32, 28, 29, 40, 44)
    18.8
    10.7
    3.4
    12.5
    15.9
        Week 16 (n = 28, 26, 27, 36, 38)
    10.7
    23.1
    7.4
    13.9
    18.4
    Notes
    [3] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving >=2 points improvement in the IGA from baseline at all scheduled time points

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    End point title
    		 Percentage of subjects achieving >=2 points improvement in the IGA from baseline at all scheduled time points
    End point description
    The IGA score quantifies the severity of subjects' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
    End point type
    Secondary
    End point timeframe
    All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [4]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Week 1 (n = 54, 48, 49, 55, 53)
    1.9
    4.2
    6.1
    5.5
    9.4
        Week 2 (n = 55, 48, 47, 53, 50)
    7.3
    10.4
    10.6
    11.3
    24.0
        Week 4 (n = 50, 45, 47, 52, 52)
    8.0
    11.1
    12.8
    25.0
    51.9
        Week 6 (n = 44, 38, 43, 48, 52)
    22.7
    23.7
    18.6
    29.2
    59.6
        Week 8 (n = 41, 36, 43, 47, 49)
    14.6
    19.4
    23.3
    34.0
    59.2
        Week 12 (n = 35, 29, 30, 43, 42)
    17.1
    17.2
    23.3
    51.2
    57.1
        Week 13 (n = 30, 29, 31, 38, 45)
    13.3
    24.1
    12.9
    26.3
    37.8
        Week 14 (n = 32, 28, 29, 40, 44)
    21.9
    17.9
    10.3
    20.0
    25.0
        Week 16 (n = 28, 26, 27, 36, 38)
    14.3
    26.9
    11.1
    22.2
    31.6
    Notes
    [4] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percent change from baseline in the EASI total score at all scheduled time points except Week 12.

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    End point title
    		 Percent change from baseline in the EASI total score at all scheduled time points except Week 12.
    End point description
    The EASI quantifies the severity of subjects' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. 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.
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [5]
    49
    51
    56
    55
    Units: percent change
    arithmetic mean (standard deviation)
        Week 1 (n = 54, 48, 49, 55, 53)
    -12.28 ± 27.205
    -13.80 ± 26.526
    -14.85 ± 33.721
    -19.85 ± 30.379
    -41.26 ± 32.064
        Week 2 (n = 55, 48, 47, 53, 50)
    -23.54 ± 33.348
    -14.79 ± 40.474
    -26.29 ± 33.298
    -38.26 ± 39.176
    -63.28 ± 25.754
        Week 4 (n = 50, 45, 47, 52, 52)
    -24.58 ± 40.520
    -30.06 ± 40.852
    -32.81 ± 40.255
    -53.59 ± 35.274
    -78.16 ± 20.666
        Week 6 (n = 44, 38, 43, 48, 52)
    -39.17 ± 39.299
    -35.18 ± 43.498
    -40.16 ± 43.849
    -54.16 ± 53.212
    -83.14 ± 17.267
        Week 8 (n = 41, 36, 43, 47, 49)
    -36.69 ± 42.629
    -39.43 ± 46.270
    -36.83 ± 52.632
    -53.96 ± 53.689
    -84.48 ± 16.226
        Week 13 (n = 30, 29, 31, 38, 45)
    -29.82 ± 50.404
    -34.11 ± 51.089
    -32.97 ± 45.223
    -51.23 ± 45.968
    -66.34 ± 34.951
        Week 14 (n = 32, 28, 29, 40, 44)
    -35.51 ± 43.357
    -31.54 ± 62.829
    -26.25 ± 49.184
    -38.80 ± 49.085
    -57.15 ± 36.739
        Week 16 (n = 28, 26, 27, 36, 38)
    -35.91 ± 47.713
    -45.24 ± 44.576
    -20.80 ± 47.915
    -27.66 ± 54.570
    -55.82 ± 32.833
    Notes
    [5] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving >=3 points improvement in the pruritus numerical rating scale (NRS) from baseline at all scheduled time points

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    End point title
    		 Percentage of subjects achieving >=3 points improvement in the pruritus numerical rating scale (NRS) from baseline at all scheduled time points
    End point description
    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [6]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Itching due to AD Day 2 (n = 50, 45, 47, 54, 53)
    4.0
    6.7
    17.0
    14.8
    17.0
        Itching due to AD Day 3 (n = 50, 45, 47, 54, 53)
    8.0
    2.2
    14.9
    22.2
    28.3
        Itching due to AD Day 4 (n = 50, 45, 47, 54, 52)
    2.0
    2.2
    21.3
    22.2
    34.6
        Itching due to AD Day 5 (n = 50, 45, 47, 54, 52)
    2.0
    6.7
    29.8
    24.1
    36.5
        Itching due to AD Day 6 (n = 50, 45, 47, 54, 52)
    10.0
    8.9
    25.5
    24.1
    40.4
        Itching due to AD Day 7 (n = 51, 45, 47, 53, 52)
    11.8
    13.3
    25.5
    30.2
    42.3
        Itching due to AD Day 8 (n = 50, 45, 48, 55, 51)
    10.0
    13.3
    25.0
    43.6
    51.0
        Itching due to AD Day 9 (n = 48, 45, 46, 55, 52)
    8.3
    11.1
    26.1
    45.5
    50.0
        Itching due to AD Day 10 (n = 49, 45, 47, 55, 52)
    8.2
    11.1
    34.0
    43.6
    55.8
        Itching due to AD Day 11 (n = 50, 45, 47, 55, 52)
    16.0
    15.6
    27.7
    43.6
    57.7
        Itching due to AD Day 12 (n = 50, 45, 47, 55, 51)
    22.0
    17.8
    38.3
    49.1
    60.8
        Itching due to AD Day 13 (n = 50, 45, 46, 52, 50)
    24.0
    15.6
    28.3
    53.8
    66.0
        Itching due to AD Day 14 (n = 49, 42, 45, 52, 49)
    22.4
    19.0
    26.7
    48.1
    67.3
        Itching due to AD Day 15 (n = 40, 39, 39, 44, 40)
    25.0
    17.9
    30.8
    54.5
    72.5
        Itching due to AD Day 29 (n = 52, 45, 45, 55, 51)
    32.7
    31.1
    37.8
    60.0
    74.5
        Itching due to AD Day 43 (n = 51, 48, 47, 54, 52)
    31.4
    35.4
    38.3
    53.7
    73.1
        Itching due to AD Day 57 (n = 52, 47, 47, 55, 50)
    28.8
    31.9
    38.3
    54.5
    72.0
        Itching due to AD Day 85 (n = 52, 47, 46, 54, 50)
    26.9
    21.3
    41.3
    53.7
    64.0
        Itching due to AD Day 99 (n = 30, 27, 27, 40, 41)
    33.3
    25.9
    33.3
    47.5
    41.5
        Itching due to AD Day 113 (n = 23, 24, 25, 36, 34)
    52.2
    29.2
    24.0
    44.4
    35.3
        Frequency Day 2 (n = 50, 45, 47, 54, 53)
    6.0
    8.9
    19.1
    22.2
    26.4
        Frequency Day 3 (n = 50, 45, 47, 54, 53)
    10.0
    8.9
    19.1
    25.9
    34.0
        Frequency Day 4 (n = 50, 45, 47, 54, 52)
    8.0
    4.4
    23.4
    25.9
    48.1
        Frequency Day 5 (n = 50, 45, 47, 54, 52)
    10.0
    6.7
    31.9
    29.6
    46.2
        Frequency Day 6 (n = 50, 45, 47, 54, 52)
    14.0
    8.9
    27.7
    33.3
    57.7
        Frequency Day 7 (n = 51, 45, 47, 53, 52)
    15.7
    11.1
    31.9
    34.0
    55.8
        Frequency Day 8 (n = 50, 45, 48, 55, 51)
    16.0
    11.1
    29.2
    45.5
    60.8
        Frequency Day 9 (n = 48, 45, 46, 55, 52)
    14.6
    13.3
    30.4
    45.5
    55.8
        Frequency Day 10 (n = 49, 45, 47, 55, 52)
    14.3
    13.3
    36.2
    45.5
    65.4
        Frequency Day 11 (n = 50, 45, 47, 55, 52)
    20.0
    15.6
    36.2
    45.5
    63.5
        Frequency Day 12 (n = 50, 45, 47, 55, 51)
    18.0
    17.8
    38.3
    50.9
    60.8
        Frequency Day 13 (n = 50, 45, 46, 52, 50)
    20.0
    20.0
    30.4
    51.9
    70.0
        Frequency Day 14 (n = 49, 42, 45, 52, 49)
    24.5
    23.8
    33.3
    48.1
    71.4
        Frequency Day 15 (n = 40, 39, 39, 44, 40)
    30.0
    20.5
    38.5
    52.3
    72.5
        Frequency Day 29 (n = 52, 45, 45, 55, 51)
    28.8
    28.9
    40.0
    60.0
    74.5
        Frequency Day 43 (n = 51, 48, 47, 54, 52)
    23.5
    35.4
    38.3
    57.4
    75.0
        Frequency Day 57 (n = 52, 47, 47, 55, 50)
    26.9
    29.8
    38.3
    54.5
    74.0
        Frequency Day 85 (n = 52, 47, 46, 54, 50)
    25.0
    25.5
    34.8
    53.7
    70.0
        Frequency Day 99 (n = 30, 27, 27, 40, 41)
    30.0
    22.2
    37.0
    47.5
    39.0
        Frequency Day 113 (n = 23, 24, 25, 36, 34)
    47.8
    25.0
    20.0
    47.2
    38.2
    Notes
    [6] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving >=4 points improvement in the pruritus NRS from baseline at all scheduled time points

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    End point title
    		 Percentage of subjects achieving >=4 points improvement in the pruritus NRS from baseline at all scheduled time points
    End point description
    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [7]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Itching due to AD Day 2 (n = 49, 45, 46, 50, 46)
    2.0
    2.2
    6.5
    10.0
    15.2
        Itching due to AD Day 3 (n = 49, 45, 46, 50, 46)
    0.0
    2.2
    13.0
    14.0
    21.7
        Itching due to AD Day 4 (n = 49, 45, 46, 50, 45)
    0.0
    0.0
    17.4
    14.0
    28.9
        Itching due to AD Day 5 (n = 49, 45, 46, 50, 45)
    2.0
    2.2
    19.6
    20.0
    26.7
        Itching due to AD Day 6 (n = 49, 45, 46, 50, 45)
    6.1
    2.2
    17.4
    24.0
    35.6
        Itching due to AD Day 7 (n = 50, 45, 46, 49, 45)
    8.0
    8.9
    19.6
    20.4
    37.8
        Itching due to AD Day 8 (n = 49, 45, 47, 51, 44)
    6.1
    4.4
    14.9
    29.4
    52.3
        Itching due to AD Day 9 (n = 47, 45, 45, 51, 45)
    2.1
    6.7
    20.0
    27.5
    51.1
        Itching due to AD Day 10 (n = 48, 45, 46, 51, 45)
    4.2
    6.7
    21.7
    29.4
    44.4
        Itching due to AD Day 11 (n = 49, 45, 46, 51, 45)
    8.2
    13.3
    19.6
    29.4
    44.4
        Itching due to AD Day 12 (n = 49, 45, 46, 51, 45)
    10.2
    11.1
    23.9
    35.3
    51.1
        Itching due to AD Day 13 (n = 49, 45, 45, 49, 44)
    14.3
    6.7
    20.0
    38.8
    61.4
        Itching due to AD Day 14 (n = 48, 42, 44, 48, 44)
    10.4
    14.3
    25.0
    41.7
    59.1
        Itching due to AD Day 15 (n = 40, 38, 38, 43, 37)
    15.0
    7.9
    31.6
    41.9
    70.3
        Itching due to AD Day 29 (n = 51, 44, 44, 51, 45)
    17.6
    13.6
    25.0
    52.9
    68.9
        Itching due to AD Day 43 (n = 50, 45, 46, 50, 46)
    20.0
    22.2
    23.9
    50.0
    71.7
        Itching due to AD Day 57 (n = 51, 44, 46, 51, 44)
    17.6
    22.7
    26.1
    52.9
    72.7
        Itching due to AD Day 85 (n = 51, 44, 45, 50, 44)
    25.5
    22.7
    33.3
    50.0
    63.6
        Itching due to AD Day 99 (n = 29, 27, 26, 39, 35)
    27.6
    25.9
    23.1
    38.5
    37.1
        Itching due to AD Day 113 (n = 23, 24, 24, 35, 29)
    43.5
    20.8
    16.7
    34.3
    31.0
        Frequency Day 2 (n = 47, 45, 42, 52, 48)
    2.1
    0.0
    7.1
    11.5
    18.8
        Frequency Day 3 (n = 47, 45, 42, 52, 48)
    6.4
    2.2
    11.9
    13.5
    22.9
        Frequency Day 4 (n = 47, 45, 42, 52, 47)
    2.1
    0.0
    19.0
    21.2
    36.2
        Frequency Day 5 (n = 47, 45, 42, 52, 47)
    4.3
    4.4
    23.8
    25.0
    38.3
        Frequency Day 6 (n = 47, 45, 42, 52, 47)
    10.6
    6.7
    26.2
    25.0
    44.7
        Frequency Day 7 (n = 48, 45, 42, 50, 47)
    10.4
    4.4
    19.0
    30.0
    51.1
        Frequency Day 8 (n = 47, 45, 43, 52, 46)
    8.5
    2.2
    23.3
    36.5
    54.3
        Frequency Day 9 (n = 45, 45, 41, 52, 47)
    6.7
    6.7
    26.8
    36.5
    48.9
        Frequency Day 10 (n = 46, 45, 42, 52, 47)
    6.5
    8.9
    31.0
    28.8
    51.1
        Frequency Day 11 (n = 47, 45, 42, 52, 47)
    10.6
    15.6
    23.8
    32.7
    55.3
        Frequency Day 12 (n = 47, 45, 42, 52, 46)
    12.8
    13.3
    26.2
    34.6
    54.3
        Frequency Day 13 (n = 47, 45, 41, 50, 45)
    17.0
    15.6
    29.3
    32.0
    66.7
        Frequency Day 14 (n = 46, 42, 40, 49, 45)
    19.6
    16.7
    30.0
    34.7
    66.7
        Frequency Day 15 (n = 40, 38, 34, 44, 38)
    20.0
    15.8
    35.3
    36.4
    71.1
        Frequency Day 29 (n = 49, 44, 40, 52, 47)
    16.3
    15.9
    35.0
    51.9
    66.0
        Frequency Day 43 (n = 48, 45, 42, 51, 48)
    12.5
    24.4
    28.6
    58.8
    72.9
        Frequency Day 57 (n = 49, 44, 42, 52, 46)
    16.3
    20.5
    33.3
    53.8
    73.9
        Frequency Day 85 (n = 49, 44, 42, 51, 46)
    24.5
    25.0
    28.6
    47.1
    69.6
        Frequency Day 99 (n = 29, 27, 24, 38, 37)
    20.7
    18.5
    16.7
    39.5
    32.4
        Frequency Day 113 (n = 23, 24, 22, 34, 30)
    34.8
    20.8
    22.7
    29.4
    26.7
    Notes
    [7] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Time to achieving >=3 points improvement in NRS

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    End point title
    		 Time to achieving >=3 points improvement in NRS
    End point description
    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).
    End point type
    Secondary
    End point timeframe
    Baseline till Week 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    55
    49
    50
    55
    54
    Units: day
    median (confidence interval 90%)
        Itching due to atopic dermatitis
    30.0 (15.0 to 56.0)
    43.0 (29.0 to 57.0)
    12.0 (8.0 to 30.0)
    9.0 (7.0 to 14.0)
    7.0 (5.0 to 11.0)
        Frequency of itching due to atopic dermatitis
    29.0 (13.0 to 57.0)
    43.0 (29.0 to 85.0)
    13.0 (7.0 to 43.0)
    8.0 (4.0 to 10.0)
    4.0 (4.0 to 6.0)
    No statistical analyses for this end point

    Secondary: Time to achieving >=4 points improvement in NRS

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    End point title
    		 Time to achieving >=4 points improvement in NRS
    End point description
    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).
    End point type
    Secondary
    End point timeframe
    Baseline till Week 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    55 [8]
    49 [9]
    50
    55
    54
    Units: day
    median (confidence interval 90%)
        Itching due to atopic dermatitis
    78.0 (56.0 to 99999)
    99999 (47.0 to 99999)
    43.0 (15.0 to 85.0)
    14.0 (10.0 to 29.0)
    10.0 (7.0 to 13.0)
        Frequency of itching due to atopic dermatitis
    59.0 (30.0 to 99999)
    99999 (56.0 to 99999)
    29.0 (12.0 to 98.0)
    14.0 (8.0 to 29.0)
    7.0 (5.0 to 9.0)
    Notes
    [8] - 99999 indicates not estimable.
    [9] - 99999 indicates not estimable.
    No statistical analyses for this end point

    Secondary: Percent change from baseline in the pruritus NRS from baseline at all scheduled time points

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    End point title
    		 Percent change from baseline in the pruritus NRS from baseline at all scheduled time points
    End point description
    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [10]
    49
    51
    56
    55
    Units: percent change
    arithmetic mean (standard deviation)
        Itching due to AD Day 2 (n = 50, 45, 47, 53, 51)
    0.56 ± 19.298
    -1.51 ± 19.857
    -9.39 ± 23.528
    -10.06 ± 25.930
    -6.79 ± 47.751
        Itching due to AD Day 3 (n = 50, 45, 47, 52, 51)
    -1.32 ± 22.630
    2.48 ± 21.994
    -8.22 ± 33.257
    -15.32 ± 27.874
    -16.72 ± 40.055
        Itching due to AD Day 4 (n = 50, 44, 47, 52, 50)
    -1.98 ± 22.326
    0.23 ± 17.314
    -12.18 ± 33.385
    -17.62 ± 25.747
    -25.80 ± 38.557
        Itching due to AD Day 5 (n = 50, 44, 47, 52, 50)
    -2.98 ± 22.385
    -2.37 ± 20.174
    -18.92 ± 31.846
    -20.48 ± 27.983
    -30.91 ± 34.215
        Itching due to AD Day 6 (n = 50, 44, 47, 52, 50)
    -1.52 ± 25.690
    -5.70 ± 23.478
    -16.70 ± 33.407
    -21.58 ± 27.842
    -34.02 ± 35.532
        Itching due to AD Day 7 (n = 51, 44, 47, 51, 50)
    -4.18 ± 30.531
    -4.59 ± 28.248
    -18.07 ± 33.640
    -23.02 ± 33.524
    -38.17 ± 35.428
        Itching due to AD Day 8 (n = 50, 44, 46, 53, 49)
    -0.35 ± 34.144
    -5.69 ± 25.576
    -17.87 ± 34.789
    -32.36 ± 30.610
    -43.13 ± 38.684
        Itching due to AD Day 9 (n = 48, 44, 42, 51, 49)
    -2.56 ± 30.688
    -8.61 ± 27.803
    -22.74 ± 33.667
    -31.82 ± 30.951
    -39.37 ± 41.055
        Itching due to AD Day 10 (n = 49, 44, 43, 51, 49)
    -3.32 ± 29.885
    -5.97 ± 29.093
    -22.90 ± 41.573
    -31.93 ± 27.094
    -39.60 ± 56.607
        Itching due to AD Day 11 (n = 49, 44, 43, 51, 49)
    -7.81 ± 30.201
    -5.94 ± 31.028
    -16.76 ± 49.412
    -33.13 ± 27.902
    -42.50 ± 51.621
        Itching due to AD Day 12 (n = 49, 44, 43, 51, 48)
    -11.12 ± 30.087
    -6.65 ± 32.617
    -27.84 ± 33.416
    -33.30 ± 34.252
    -46.40 ± 46.241
        Itching due to AD Day 13 (n = 48, 44, 42, 49, 47)
    -15.16 ± 29.759
    -7.43 ± 27.374
    -24.56 ± 30.086
    -35.89 ± 35.651
    -49.77 ± 48.426
        Itching due to AD Day 14 (n = 47, 41, 41, 48, 46)
    -13.61 ± 30.153
    -8.84 ± 29.474
    -26.70 ± 29.805
    -36.57 ± 27.552
    -55.45 ± 34.331
        Itching due to AD Day 15 (n = 38, 35, 35, 42, 38)
    -17.24 ± 30.755
    -7.28 ± 28.058
    -25.09 ± 37.815
    -35.41 ± 29.140
    -59.00 ± 39.804
        Itching due to AD Day 29 (n = 46, 41, 41, 51, 49)
    -19.43 ± 35.575
    -16.63 ± 34.554
    -28.41 ± 36.183
    -46.62 ± 40.090
    -68.09 ± 31.214
        Itching due to AD Day 43 (n = 40, 37, 40, 46, 50)
    -26.55 ± 36.418
    -27.15 ± 39.550
    -31.14 ± 39.090
    -49.49 ± 46.279
    -67.80 ± 36.372
        Itching due to AD Day 57 (n = 38, 34, 40, 46, 46)
    -25.54 ± 39.577
    -21.60 ± 44.446
    -29.60 ± 39.606
    -54.11 ± 36.374
    -70.13 ± 36.338
        Itching due to AD Day 85 (n = 35, 30, 31, 42, 44)
    -30.10 ± 42.697
    -22.47 ± 48.291
    -30.39 ± 47.772
    -56.51 ± 41.955
    -53.66 ± 109.454
        Itching due to AD Day 99 (n = 30, 27, 27, 39, 41)
    -19.24 ± 43.251
    -15.94 ± 42.332
    -11.46 ± 39.959
    -32.68 ± 34.789
    5.61 ± 139.223
        Itching due to AD Day 113 (n = 23, 24, 25, 35, 34)
    -31.99 ± 45.929
    -14.07 ± 47.186
    -14.34 ± 29.756
    -28.47 ± 41.027
    24.61 ± 190.848
        Frequency Day 2 (n = 50, 45, 47, 53, 52)
    6.72 ± 45.759
    -6.67 ± 19.016
    -10.14 ± 28.184
    -17.93 ± 20.967
    -10.52 ± 79.180
        Frequency Day 3 (n = 50, 45, 47, 52, 52)
    2.59 ± 45.541
    0.30 ± 24.330
    -3.96 ± 49.425
    -19.98 ± 22.910
    -16.46 ± 67.794
        Frequency Day 4 (n = 50, 44, 47, 52, 51)
    3.73 ± 37.683
    -3.25 ± 15.230
    -9.39 ± 39.225
    -20.71 ± 24.391
    -28.27 ± 47.925
        Frequency Day 5 (n = 50, 44, 47, 52, 51)
    -0.70 ± 34.834
    -3.73 ± 23.125
    -17.72 ± 38.967
    -23.69 ± 24.954
    -35.45 ± 37.436
        Frequency Day 6 (n = 50, 44, 47, 52, 51)
    4.04 ± 52.799
    -5.76 ± 24.623
    -14.84 ± 38.256
    -26.47 ± 27.218
    -44.31 ± 36.476
        Frequency Day 7 (n = 51, 44, 47, 51, 51)
    -2.25 ± 37.193
    -3.56 ± 25.414
    -17.05 ± 40.108
    -27.80 ± 32.466
    -40.19 ± 39.702
        Frequency Day 8 (n = 50, 44, 46, 53, 50)
    1.22 ± 38.544
    -3.90 ± 25.515
    -19.05 ± 36.488
    -35.44 ± 29.791
    -46.26 ± 43.491
        Frequency Day 9 (n = 48, 44, 42, 51, 50)
    1.08 ± 58.633
    -8.79 ± 26.589
    -17.58 ± 42.054
    -35.17 ± 29.637
    -44.29 ± 43.238
        Frequency Day 10 (n = 49, 44, 43, 51, 50)
    -3.47 ± 53.518
    -5.41 ± 32.491
    -19.84 ± 47.884
    -33.23 ± 26.950
    -49.78 ± 37.349
        Frequency Day 11 (n = 49, 44, 43, 51, 50)
    -6.24 ± 49.163
    -5.88 ± 32.750
    -18.73 ± 42.599
    -34.93 ± 27.181
    -51.62 ± 37.385
        Frequency Day 12 (n = 49, 44, 43, 51, 49)
    -8.41 ± 49.918
    -5.65 ± 36.637
    -25.00 ± 31.695
    -36.55 ± 27.281
    -51.92 ± 40.010
        Frequency Day 13 (n = 48, 44, 42, 49, 48)
    -13.45 ± 40.159
    -10.46 ± 31.103
    -24.73 ± 31.960
    -35.75 ± 32.757
    -53.17 ± 40.695
        Frequency Day 14 (n = 47, 41, 41, 48, 47)
    -10.26 ± 46.126
    -13.86 ± 32.390
    -27.70 ± 30.476
    -38.28 ± 27.724
    -57.50 ± 39.073
        Frequency Day 15 (n = 38, 35, 35, 42, 38)
    -18.78 ± 34.923
    -11.34 ± 28.494
    -26.88 ± 38.846
    -38.87 ± 29.184
    -60.99 ± 32.840
        Frequency Day 29 (n = 46, 41, 41, 51, 49)
    -16.05 ± 39.630
    -17.15 ± 33.432
    -28.55 ± 43.421
    -49.94 ± 36.649
    -67.84 ± 29.918
        Frequency Day 43 (n = 40, 37, 40, 46, 50)
    -24.51 ± 30.798
    -32.19 ± 37.806
    -26.48 ± 46.793
    -53.95 ± 41.772
    -69.24 ± 38.370
        Frequency Day 57 (n = 38, 34, 40, 46, 46)
    -24.94 ± 35.662
    -23.28 ± 44.257
    -27.91 ± 39.142
    -55.39 ± 35.447
    -73.50 ± 30.583
        Frequency Day 85 (n = 35, 30, 31, 42, 44)
    -29.81 ± 44.035
    -25.76 ± 43.273
    -32.28 ± 38.817
    -54.51 ± 43.354
    -54.54 ± 120.723
        Frequency Day 99 (n = 30, 27, 27, 39, 41)
    -17.46 ± 43.552
    -20.21 ± 36.947
    -3.36 ± 52.153
    -13.57 ± 123.800
    2.12 ± 144.572
        Frequency Day 113 (n = 23, 24, 25, 35, 34)
    -28.95 ± 46.896
    -16.22 ± 38.055
    -5.65 ± 51.132
    -12.62 ± 113.423
    27.77 ± 203.937
    Notes
    [10] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Change from baseline in pruritus NRS score at all scheduled time points

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    End point title
    		 Change from baseline in pruritus NRS score at all scheduled time points
    End point description
    The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10). The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects were asked to assess “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [11]
    49
    51
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Itching due to AD Day 2 (n = 50, 45, 47, 54, 52)
    -0.08 ± 1.307
    -0.20 ± 1.217
    -0.83 ± 1.672
    -0.85 ± 1.607
    -1.00 ± 2.433
        Itching due to AD Day 3 (n = 50, 45, 47, 53, 52)
    -0.22 ± 1.418
    0.02 ± 1.357
    -0.85 ± 2.095
    -1.21 ± 1.702
    -1.48 ± 2.493
        Itching due to AD Day 4 (n = 50, 44, 47, 53, 51)
    -0.22 ± 1.389
    -0.09 ± 1.117
    -1.09 ± 2.263
    -1.26 ± 1.862
    -2.12 ± 2.590
        Itching due to AD Day 5 (n = 50, 44, 47, 53, 51)
    -0.32 ± 1.406
    -0.27 ± 1.264
    -1.55 ± 2.348
    -1.58 ± 1.865
    -2.35 ± 2.583
        Itching due to AD Day 6 (n = 50, 44, 47, 53, 51)
    -0.28 ± 1.727
    -0.55 ± 1.405
    -1.47 ± 2.492
    -1.49 ± 2.317
    -2.53 ± 2.648
        Itching due to AD Day 7 (n = 51, 44, 47, 52, 51)
    -0.53 ± 2.023
    -0.52 ± 1.745
    -1.51 ± 2.422
    -1.75 ± 2.159
    -2.77 ± 2.795
        Itching due to AD Day 8 (n = 50, 44, 46, 54, 50)
    -0.30 ± 2.215
    -0.56 ± 1.560
    -1.65 ± 2.514
    -2.39 ± 2.294
    -3.22 ± 3.039
        Itching due to AD Day 9 (n = 48, 44, 42, 52, 50)
    -0.38 ± 2.080
    -0.75 ± 1.844
    -1.95 ± 2.527
    -2.40 ± 2.154
    -3.18 ± 2.988
        Itching due to AD Day 10 (n = 49, 44, 43, 52, 50)
    -0.43 ± 1.947
    -0.61 ± 1.967
    -2.09 ± 2.698
    -2.21 ± 2.412
    -3.38 ± 2.975
        Itching due to AD Day 11 (n = 49, 44, 43, 52, 50)
    -0.73 ± 1.955
    -0.61 ± 2.148
    -1.72 ± 2.462
    -2.33 ± 2.415
    -3.40 ± 3.071
        Itching due to AD Day 12 (n = 49, 44, 43, 52, 49)
    -0.92 ± 1.988
    -0.73 ± 2.245
    -2.28 ± 2.271
    -2.46 ± 2.578
    -3.63 ± 3.154
        Itching due to AD Day 13 (n = 48, 44, 42, 49, 48)
    -1.21 ± 1.989
    -0.68 ± 1.801
    -1.98 ± 2.268
    -2.84 ± 2.164
    -3.88 ± 3.085
        Itching due to AD Day 14 (n = 47, 41, 41, 49, 47)
    -1.11 ± 2.003
    -0.78 ± 2.104
    -2.10 ± 2.211
    -2.53 ± 2.567
    -4.06 ± 2.793
        Itching due to AD Day 15 (n = 38, 35, 35, 42, 38)
    -1.39 ± 2.034
    -0.69 ± 1.937
    -2.06 ± 2.508
    -2.79 ± 2.290
    -4.37 ± 2.696
        Itching due to AD Day 29 (n = 46, 41, 41, 52, 49)
    -1.63 ± 2.453
    -1.34 ± 2.383
    -2.17 ± 2.519
    -3.58 ± 3.322
    -5.00 ± 2.880
        Itching due to AD Day 43 (n = 40, 37, 40, 47, 50)
    -1.93 ± 2.325
    -2.24 ± 2.929
    -2.50 ± 2.562
    -3.77 ± 3.778
    -5.02 ± 3.172
        Itching due to AD Day 57 (n = 38, 34, 40, 47, 46)
    -1.84 ± 2.594
    -1.97 ± 3.398
    -2.55 ± 2.943
    -4.00 ± 3.336
    -5.26 ± 3.130
        Itching due to AD Day 85 (n = 35, 30, 31, 43, 44)
    -2.26 ± 3.081
    -2.13 ± 3.711
    -2.68 ± 2.749
    -4.21 ± 3.529
    -4.84 ± 3.785
        Itching due to AD Day 99 (n = 30, 27, 27, 40, 41)
    -1.57 ± 3.025
    -1.48 ± 2.992
    -1.37 ± 2.452
    -2.28 ± 2.900
    -1.90 ± 3.767
        Itching due to AD Day 113 (n = 23, 24, 25, 36, 34)
    -2.43 ± 3.259
    -1.38 ± 3.201
    -1.32 ± 2.410
    -2.03 ± 3.185
    -1.50 ± 3.736
        Frequency Day 2 (n = 50, 45, 47, 54, 52)
    -0.06 ± 1.754
    -0.44 ± 1.198
    -0.94 ± 1.737
    -1.35 ± 1.556
    -1.60 ± 2.345
        Frequency Day 3 (n = 50, 45, 47, 53, 52)
    -0.38 ± 1.894
    -0.16 ± 1.461
    -0.79 ± 2.331
    -1.49 ± 1.694
    -1.92 ± 2.300
        Frequency Day 4 (n = 50, 44, 47, 53, 51)
    -0.20 ± 1.738
    -0.32 ± 1.073
    -1.02 ± 2.162
    -1.40 ± 2.069
    -2.47 ± 2.533
        Frequency Day 5 (n = 50, 44, 47, 53, 51)
    -0.42 ± 1.727
    -0.43 ± 1.516
    -1.49 ± 2.349
    -1.75 ± 1.828
    -2.73 ± 2.515
        Frequency Day 6 (n = 50, 44, 47, 53, 51)
    -0.40 ± 2.250
    -0.55 ± 1.606
    -1.40 ± 2.402
    -1.77 ± 2.326
    -3.24 ± 2.446
        Frequency Day 7 (n = 51, 44, 47, 52, 51)
    -0.63 ± 2.181
    -0.43 ± 1.676
    -1.53 ± 2.466
    -2.04 ± 2.214
    -3.15 ± 2.739
        Frequency Day 8 (n = 50, 44, 46, 54, 50)
    -0.42 ± 2.205
    -0.40 ± 1.679
    -1.74 ± 2.542
    -2.59 ± 2.278
    -3.69 ± 2.808
        Frequency Day 9 (n = 48, 44, 42, 52, 50)
    -0.54 ± 2.240
    -0.75 ± 2.036
    -1.74 ± 2.567
    -2.62 ± 2.268
    -3.54 ± 3.018
        Frequency Day 10 (n = 49, 44, 43, 52, 50)
    -0.80 ± 2.198
    -0.64 ± 2.200
    -1.84 ± 2.760
    -2.33 ± 2.565
    -3.68 ± 2.591
        Frequency Day 11 (n = 49, 44, 43, 52, 50)
    -0.96 ± 2.336
    -0.68 ± 2.380
    -1.79 ± 2.541
    -2.46 ± 2.540
    -3.74 ± 2.633
        Frequency Day 12 (n = 49, 44, 43, 52, 49)
    -1.06 ± 2.322
    -0.66 ± 2.411
    -2.00 ± 2.182
    -2.54 ± 2.509
    -3.84 ± 2.932
        Frequency Day 13 (n = 48, 44, 42, 49, 48)
    -1.33 ± 2.337
    -0.91 ± 2.133
    -1.90 ± 2.195
    -2.78 ± 2.275
    -4.08 ± 2.952
        Frequency Day 14 (n = 47, 41, 41, 49, 47)
    -1.17 ± 2.417
    -1.10 ± 2.417
    -2.00 ± 2.225
    -2.63 ± 2.620
    -4.28 ± 2.841
        Frequency Day 15 (n = 38, 35, 35, 42, 38)
    -1.50 ± 2.322
    -0.97 ± 2.135
    -2.17 ± 2.407
    -3.02 ± 2.464
    -4.50 ± 2.648
        Frequency Day 29 (n = 46, 41, 41, 52, 49)
    -1.46 ± 2.518
    -1.34 ± 2.425
    -2.22 ± 2.761
    -3.77 ± 3.317
    -5.06 ± 2.817
        Frequency Day 43 (n = 40, 37, 40, 47, 50)
    -1.70 ± 1.990
    -2.51 ± 3.061
    -2.28 ± 2.953
    -4.02 ± 3.796
    -5.30 ± 2.957
        Frequency Day 57 (n = 38, 34, 40, 47, 46)
    -1.74 ± 2.298
    -2.00 ± 3.499
    -2.45 ± 2.943
    -4.02 ± 3.467
    -5.59 ± 3.037
        Frequency Day 85 (n = 35, 30, 31, 43, 44)
    -2.23 ± 3.209
    -2.33 ± 3.575
    -2.61 ± 2.692
    -4.09 ± 3.663
    -5.14 ± 3.645
        Frequency Day 99 (n = 30, 27, 27, 40, 41)
    -1.30 ± 2.781
    -1.56 ± 2.736
    -0.93 ± 2.526
    -2.03 ± 3.378
    -2.15 ± 3.909
        Frequency Day 113 (n = 23, 24, 25, 36, 34)
    -2.00 ± 2.970
    -1.42 ± 3.035
    -1.04 ± 2.557
    -1.81 ± 3.188
    -1.50 ± 3.816
    Notes
    [11] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a >=50% improvement in the EASI Total Score (EASI50) at all scheduled time points

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    End point title
    		 Percentage of subjects achieving a >=50% improvement in the EASI Total Score (EASI50) at all scheduled time points
    End point description
    The EASI quantifies the severity of subjects' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. 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.
    End point type
    Secondary
    End point timeframe
    All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [12]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Week 1 (n = 54, 48, 50, 55, 54)
    9.3
    8.3
    14.0
    12.7
    40.7
        Week 2 (n = 55, 49, 50, 55, 52)
    27.3
    16.3
    24.0
    36.4
    65.4
        Week 4 (n = 55, 49, 50, 55, 54)
    27.3
    30.6
    36.0
    58.2
    85.2
        Week 6 (n = 55, 49, 50, 55, 54)
    36.4
    30.6
    40.0
    60.0
    90.7
        Week 8 (n = 55, 49, 50, 55, 53)
    30.9
    36.7
    40.0
    60.0
    90.6
        Week 12 (n = 52, 46, 45, 54, 48)
    26.9
    26.1
    33.3
    55.6
    79.2
        Week 13 (n = 30, 29, 31, 38, 45)
    43.3
    41.4
    45.2
    55.3
    75.6
        Week 14 (n = 32, 28, 29, 40, 44)
    37.5
    42.9
    37.9
    50.0
    65.9
        Week 16 (n = 28, 26, 27, 36, 38)
    42.9
    42.3
    33.3
    41.7
    68.4
    Notes
    [12] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a >=75% improvement in the EASI Total Score (EASI75) at all scheduled time points

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    End point title
    		 Percentage of subjects achieving a >=75% improvement in the EASI Total Score (EASI75) at all scheduled time points
    End point description
    The EASI quantifies the severity of subjects' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of four regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. 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.
    End point type
    Secondary
    End point timeframe
    All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [13]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Week 1 (n = 54, 48, 50, 55, 54)
    3.7
    2.1
    6.0
    3.6
    16.7
        Week 2 (n = 55, 49, 50, 55, 52)
    5.5
    12.2
    6.0
    12.7
    36.5
        Week 4 (n = 55, 49, 50, 55, 54)
    10.9
    18.4
    20.0
    27.3
    57.4
        Week 6 (n = 55, 49, 50, 55, 54)
    16.4
    18.4
    18.0
    38.2
    68.5
        Week 8 (n = 55, 49, 50, 55, 53)
    20.0
    22.4
    22.0
    40.0
    73.6
        Week 12 (n = 52, 46, 45, 54, 48)
    15.4
    17.4
    13.3
    40.7
    64.6
        Week 13 (n = 30, 29, 31, 38, 45)
    26.7
    27.6
    12.9
    36.8
    55.6
        Week 14 (n = 32, 28, 29, 40, 44)
    31.3
    25.0
    6.9
    35.0
    45.5
        Week 16 (n = 28, 26, 27, 36, 38)
    32.1
    38.5
    3.7
    25.0
    36.8
    Notes
    [13] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a >=90% improvement in the EASI Total Score (EASI90) at all scheduled time points

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    End point title
    		 Percentage of subjects achieving a >=90% improvement in the EASI Total Score (EASI90) at all scheduled time points
    End point description
    The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of four regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. 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.
    End point type
    Secondary
    End point timeframe
    All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [14]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Week 1 (n = 54, 48, 50, 55, 54)
    0.0
    2.1
    4.0
    0.0
    7.4
        Week 2 (n = 55, 49, 50, 55, 52)
    0.0
    6.1
    4.0
    5.5
    19.2
        Week 4 (n = 55, 49, 50, 55, 54)
    1.8
    8.2
    8.0
    10.9
    38.9
        Week 6 (n = 55, 49, 50, 55, 54)
    7.3
    14.3
    14.0
    16.4
    44.4
        Week 8 (n = 55, 49, 50, 55, 53)
    5.5
    12.2
    8.0
    23.6
    43.4
        Week 12 (n = 52, 46, 45, 54, 48)
    9.6
    10.9
    0.0
    25.9
    52.1
        Week 13 (n = 30, 29, 31, 38, 45)
    10.0
    13.8
    3.2
    23.7
    31.1
        Week 14 (n = 32, 28, 29, 40, 44)
    15.6
    14.3
    0.0
    17.5
    18.2
        Week 16 (n = 28, 26, 27, 36, 38)
    14.3
    23.1
    3.7
    8.3
    10.5
    Notes
    [14] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Change from baseline in affected body surface area (BSA) at all scheduled time points

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    End point title
    		 Change from baseline in affected body surface area (BSA) at all scheduled time points
    End point description
    BSA Efficacy was 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%.
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [15]
    49
    51
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 1 (n = 54, 48, 49, 55, 53)
    -0.06 ± 6.699
    -3.76 ± 13.940
    -2.45 ± 7.017
    -4.63 ± 12.144
    -10.86 ± 15.690
        Week 2 (n = 55, 48, 47, 53, 50)
    -5.43 ± 10.030
    -4.84 ± 16.179
    -6.51 ± 10.485
    -10.80 ± 16.432
    -21.30 ± 19.285
        Week 4 (n = 50, 45, 47, 52, 52)
    -6.34 ± 16.138
    -8.93 ± 15.960
    -9.59 ± 14.845
    -17.77 ± 19.956
    -28.55 ± 20.447
        Week 6 (n = 44, 38, 43, 48, 52)
    -10.79 ± 16.413
    -11.80 ± 22.324
    -10.71 ± 15.007
    -18.80 ± 23.387
    -30.51 ± 20.853
        Week 8 (n = 41, 36, 43, 47, 49)
    -9.71 ± 17.837
    -12.98 ± 25.552
    -10.79 ± 19.259
    -19.41 ± 23.596
    -29.98 ± 20.864
        Week 12 (n = 35, 29, 30, 43, 42)
    -13.82 ± 22.348
    -11.59 ± 27.112
    -9.37 ± 18.783
    -22.21 ± 22.199
    -27.72 ± 18.361
        Week 13 (n = 30, 29, 31, 38, 45)
    -7.90 ± 18.233
    -11.07 ± 25.457
    -7.79 ± 17.469
    -17.88 ± 20.905
    -22.61 ± 22.390
        Week 14 (n = 32, 28, 29, 40, 44)
    -8.97 ± 16.223
    -10.46 ± 26.130
    -6.33 ± 17.404
    -12.75 ± 22.492
    -16.35 ± 18.931
        Week 16 (n = 28, 26, 27, 36, 38)
    -8.09 ± 15.797
    -14.64 ± 20.948
    -3.52 ± 20.967
    -5.55 ± 21.079
    -17.88 ± 17.059
    Notes
    [15] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Change from baseline in scoring atopic dermatitis (SCORAD) at all scheduled time points

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    End point title
    		 Change from baseline in scoring atopic dermatitis (SCORAD) at all scheduled time points
    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 or caregiver using a numeric rating scale (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).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [16]
    49
    51
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 1 (n = 54, 48, 49, 55, 53)
    -7.910 ± 12.4625
    -5.000 ± 13.3310
    -8.388 ± 14.6316
    -12.024 ± 12.4053
    -21.326 ± 15.8867
        Week 2 (n = 55, 48, 47, 53, 50)
    -10.905 ± 15.4157
    -8.795 ± 16.3883
    -13.266 ± 14.5268
    -20.286 ± 15.2402
    -32.152 ± 14.4354
        Week 4 (n = 50, 45, 47, 52, 52)
    -14.555 ± 16.6414
    -14.116 ± 19.1643
    -15.496 ± 16.4795
    -28.058 ± 16.6775
    -39.567 ± 14.7328
        Week 6 (n = 44, 38, 43, 48, 52)
    -19.527 ± 16.7869
    -16.667 ± 21.8577
    -19.930 ± 17.5966
    -29.729 ± 21.6156
    -41.458 ± 14.3943
        Week 8 (n = 41, 36, 43, 47, 49)
    -19.052 ± 18.5735
    -18.853 ± 21.7947
    -19.534 ± 18.7098
    -30.148 ± 20.7887
    -42.604 ± 13.9771
        Week 12 (n = 35, 29, 30, 43, 42)
    -18.647 ± 20.0191
    -17.986 ± 23.1948
    -21.211 ± 17.6774
    -33.145 ± 21.4221
    -41.384 ± 15.4359
        Week 13 (n = 30, 29, 31, 38, 45)
    -16.603 ± 21.3850
    -16.895 ± 22.1132
    -15.023 ± 16.1573
    -24.261 ± 19.4912
    -29.884 ± 19.1501
        Week 14 (n = 32, 28, 29, 40, 44)
    -17.987 ± 22.0893
    -15.842 ± 19.5000
    -12.768 ± 13.6914
    -20.211 ± 20.2920
    -21.292 ± 17.7775
        Week 16 (n = 28, 26, 27, 36, 38)
    -19.408 ± 22.1744
    -18.925 ± 21.5459
    -12.716 ± 15.9390
    -17.753 ± 19.1842
    -21.024 ± 18.1576
    Notes
    [16] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percent change from baseline in SCORAD at all scheduled time points

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    End point title
    		 Percent change from baseline in SCORAD at all scheduled time points
    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 or caregiver using a numeric rating scale (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).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [17]
    49
    51
    56
    55
    Units: percent change
    arithmetic mean (standard deviation)
        Week 1 (n = 54, 48, 49, 55, 53)
    -11.547 ± 19.7128
    -7.287 ± 20.6403
    -13.068 ± 21.0746
    -19.185 ± 20.0094
    -34.660 ± 25.0837
        Week 2 (n = 55, 48, 47, 53, 50)
    -16.488 ± 23.0011
    -12.980 ± 25.5198
    -20.613 ± 21.0283
    -31.025 ± 23.9881
    -51.384 ± 21.3581
        Week 4 (n = 50, 45, 47, 52, 52)
    -22.476 ± 26.5163
    -20.751 ± 29.0846
    -24.866 ± 25.3755
    -43.846 ± 26.2001
    -63.970 ± 21.6701
        Week 6 (n = 44, 38, 43, 48, 52)
    -30.789 ± 27.9424
    -25.851 ± 34.2950
    -31.276 ± 29.6517
    -45.270 ± 34.3893
    -66.971 ± 22.4343
        Week 8 (n = 41, 36, 43, 47, 49)
    -29.624 ± 30.5625
    -28.599 ± 33.1460
    -30.480 ± 29.4742
    -46.187 ± 32.7984
    -69.736 ± 21.4403
        Week 12 (n = 35, 29, 30, 43, 42)
    -29.379 ± 31.9081
    -27.607 ± 36.5015
    -32.535 ± 25.2711
    -51.624 ± 33.0106
    -68.537 ± 24.2392
        Week 13 (n = 30, 29, 31, 38, 45)
    -26.794 ± 34.3384
    -26.905 ± 34.1879
    -24.232 ± 26.2461
    -38.193 ± 32.3458
    -48.428 ± 30.1133
        Week 14 (n = 32, 28, 29, 40, 44)
    -29.393 ± 36.6642
    -25.511 ± 31.1985
    -20.072 ± 21.7399
    -31.521 ± 34.1268
    -36.519 ± 28.5404
        Week 16 (n = 28, 26, 27, 36, 38)
    -31.972 ± 36.5058
    -30.135 ± 34.2361
    -19.794 ± 25.0550
    -29.130 ± 33.1868
    -34.995 ± 27.4996
    Notes
    [17] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a >=50% improvement in SCORAD (SCORAD50) from baseline at all scheduled time points

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    End point title
    		 Percentage of subjects achieving a >=50% improvement in SCORAD (SCORAD50) from baseline at all scheduled time points
    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 or caregiver using a numeric rating scale (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).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [18]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Week 1 (n = 54, 48, 50, 55, 54)
    3.7
    2.1
    6.0
    7.3
    29.6
        Week 2 (n = 55, 49, 50, 55, 52)
    5.5
    10.2
    10.0
    18.2
    55.8
        Week 4 (n = 55, 49, 50, 55, 54)
    20.0
    12.2
    16.0
    43.6
    75.9
        Week 6 (n = 55, 49, 50, 55, 54)
    21.8
    16.3
    26.0
    45.5
    74.1
        Week 8 (n = 55, 49, 50, 55, 53)
    23.6
    22.4
    30.0
    43.6
    73.6
        Week 12 (n = 52, 46, 45, 54, 48)
    19.2
    13.0
    15.6
    50.0
    72.9
        Week 13 (n = 30, 29, 31, 38, 45)
    26.7
    20.7
    16.1
    34.2
    48.9
        Week 14 (n = 32, 28, 29, 40, 44)
    31.3
    17.9
    3.4
    32.5
    36.4
        Week 16 (n = 28, 26, 27, 36, 38)
    39.3
    30.8
    14.8
    25.0
    34.2
    Notes
    [18] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a >=75% improvement in SCORAD (SCORAD75) from baseline at all scheduled time points

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    End point title
    		 Percentage of subjects achieving a >=75% improvement in SCORAD (SCORAD75) from baseline at all scheduled time points
    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 or caregiver using a numeric rating scale (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).
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [19]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Week 1 (n = 54, 48, 50, 55, 54)
    0.0
    2.1
    2.0
    1.8
    3.7
        Week 2 (n = 55, 49, 50, 55, 52)
    0.0
    2.0
    2.0
    3.6
    11.5
        Week 4 (n = 55, 49, 50, 55, 54)
    1.8
    4.1
    4.0
    14.5
    27.8
        Week 6 (n = 55, 49, 50, 55, 54)
    5.5
    12.2
    4.0
    20.0
    37.0
        Week 8 (n = 55, 49, 50, 55, 53)
    3.6
    6.1
    2.0
    16.4
    35.8
        Week 12 (n = 52, 46, 45, 54, 48)
    3.8
    10.9
    0.0
    18.5
    37.5
        Week 13 (n = 30, 29, 31, 38, 45)
    13.3
    10.3
    0.0
    18.4
    15.6
        Week 14 (n = 32, 28, 29, 40, 44)
    15.6
    7.1
    0.0
    12.5
    11.4
        Week 16 (n = 28, 26, 27, 36, 38)
    14.3
    11.5
    0.0
    11.1
    2.6
    Notes
    [19] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Number of subjects with treatment-emergent adverse events (AEs)

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    End point title
    		 Number of subjects with treatment-emergent adverse events (AEs)
    End point description
    An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.
    End point type
    Secondary
    End point timeframe
    Baseline till Week 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56
    49
    51
    56
    55
    Units: subjects
    32
    34
    34
    43
    41
    No statistical analyses for this end point

    Secondary: Number of subjects with specific clinical laboratory abnormalities (anemia, neutropenia, thrombocytopenia, lymphopenia, lipid profile, liver function tests (LFTs)

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    End point title
    		 Number of subjects with specific clinical laboratory abnormalities (anemia, neutropenia, thrombocytopenia, lymphopenia, lipid profile, liver function tests (LFTs)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56
    49
    51
    56
    55
    Units: subjects
        AEs of anemia
    0
    0
    0
    0
    0
        AEs of neutropenia
    0
    0
    0
    0
    1
        AEs of thrombocytopenia
    0
    0
    0
    0
    1
        AEs of lymphopenia
    0
    0
    0
    0
    0
        AEs of lipid profile
    0
    0
    0
    0
    0
        AEs of liver function tests
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects with patient global assessment (PtGA) of AD of clear (0) or almost clear (1) and >=2 points improvement from baseline at all scheduled time points

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    End point title
    		 Percentage of subjects with patient global assessment (PtGA) of AD of clear (0) or almost clear (1) and >=2 points improvement from baseline at all scheduled time points
    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.
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [20]
    49
    51
    56
    55
    Units: percentage of subjects
    number (not applicable)
        Week 1 (n = 53, 48, 49, 53, 54)
    0.0
    2.1
    4.1
    1.9
    16.7
        Week 2 (n = 54, 49, 49, 54, 52)
    5.6
    0.0
    6.1
    16.7
    32.7
        Week 4 (n = 53, 49, 49, 54, 53)
    3.8
    6.1
    8.2
    22.2
    54.7
        Week 6 (n = 53, 49, 49, 54, 54)
    3.8
    10.2
    8.2
    22.2
    51.9
        Week 8 (n = 54, 49, 49, 54, 53)
    1.9
    6.1
    6.1
    24.1
    56.6
        Week 12 (n = 54, 48, 48, 54, 52)
    7.4
    12.5
    0.0
    25.9
    51.9
        Week 14 (n = 31, 29, 28, 38, 45)
    3.2
    10.3
    0.0
    15.8
    15.6
        Week 16 (n = 27, 26, 26, 34, 38)
    11.1
    7.7
    0.0
    11.8
    10.5
    Notes
    [20] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Change from baseline in dermatology life quality index (DLQI) total score at all scheduled time points

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    End point title
    		 Change from baseline in dermatology life quality index (DLQI) total score at all scheduled time points
    End point description
    The DLQI is a general dermatology questionnaire that consists of 10 items that assess subject 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 2-5 point change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [21]
    49
    51
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 1 (n = 53, 48, 48, 54, 53)
    -1.4 ± 6.04
    -1.4 ± 5.66
    -3.4 ± 6.28
    -5.1 ± 5.40
    -6.3 ± 5.55
        Week 2 (n = 53, 48, 46, 52, 50)
    -2.3 ± 5.42
    -1.9 ± 6.58
    -5.0 ± 5.55
    -7.5 ± 6.39
    -8.6 ± 6.46
        Week 4 (n = 48, 45, 45, 51, 51)
    -2.6 ± 6.77
    -3.7 ± 7.33
    -4.7 ± 5.62
    -8.2 ± 7.48
    -9.7 ± 6.82
        Week 6 (n = 42, 38, 42, 47, 52)
    -4.2 ± 6.01
    -4.6 ± 7.30
    -4.1 ± 7.75
    -9.1 ± 6.75
    -10.2 ± 6.72
        Week 8 (n = 40, 36, 42, 46, 49)
    -3.7 ± 7.67
    -5.6 ± 8.44
    -4.8 ± 8.52
    -9.2 ± 7.95
    -9.8 ± 7.10
        Week 12 (n = 36, 31, 33, 43, 46)
    -4.6 ± 8.49
    -4.5 ± 8.90
    -5.2 ± 7.30
    -9.8 ± 8.18
    -9.5 ± 7.28
        Week 14 (n = 31, 29, 28, 39, 45)
    -3.1 ± 8.24
    -3.9 ± 7.62
    -3.6 ± 6.60
    -6.2 ± 7.87
    -4.4 ± 8.78
        Week 16 (n = 27, 26, 26, 34, 38)
    -4.5 ± 7.95
    -4.5 ± 7.14
    -3.5 ± 7.17
    -4.6 ± 7.62
    -3.6 ± 7.39
    Notes
    [21] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Change from baseline in patient oriented eczema measure (POEM) at all scheduled time points

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    End point title
    		 Change from baseline in patient oriented eczema measure (POEM) at all scheduled time points
    End point description
    The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week.
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [22]
    49
    51
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 1 (n = 53, 48, 48, 53, 50)
    -1.1 ± 3.59
    -0.6 ± 4.17
    -2.1 ± 5.83
    -3.9 ± 4.67
    -9.2 ± 5.77
        Week 2 (n = 51, 48, 45, 50, 50)
    -2.2 ± 4.20
    -1.9 ± 6.13
    -4.1 ± 6.04
    -7.2 ± 6.79
    -11.9 ± 5.95
        Week 4 (n = 48, 45, 44, 50, 50)
    -2.2 ± 6.05
    -3.6 ± 6.35
    -4.3 ± 5.69
    -8.7 ± 8.30
    -14.6 ± 6.20
        Week 6 (n = 41, 38, 42, 45, 50)
    -3.5 ± 5.24
    -4.3 ± 7.63
    -3.9 ± 7.43
    -10.4 ± 8.17
    -15.0 ± 5.92
        Week 8 (n = 40, 36, 42, 45, 48)
    -2.3 ± 5.91
    -4.3 ± 8.94
    -5.4 ± 8.05
    -10.6 ± 8.47
    -15.2 ± 6.15
        Week 12 (n = 36, 31, 33, 41, 45)
    -3.8 ± 8.21
    -4.7 ± 8.83
    -5.3 ± 7.60
    -11.4 ± 8.08
    -15.1 ± 6.99
        Week 14 (n = 31, 29, 28, 38, 44)
    -2.2 ± 6.45
    -3.9 ± 8.04
    -2.7 ± 6.05
    -6.3 ± 7.12
    -6.2 ± 6.97
        Week 16 (n = 27, 26, 26, 34, 37)
    -3.0 ± 7.76
    -3.0 ± 7.67
    -2.2 ± 6.80
    -4.3 ± 6.20
    -5.9 ± 5.93
    Notes
    [22] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Secondary: Change from baseline in the hospital and anxiety depression scale (HADS) at all scheduled time points

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    End point title
    		 Change from baseline in the hospital and anxiety depression scale (HADS) at all scheduled time points
    End point description
    The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities.
    End point type
    Secondary
    End point timeframe
    Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
    End point values
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Number of subjects analysed
    56 [23]
    49
    51
    56
    55
    Units: units on a scale
    arithmetic mean (standard deviation)
        Depression score Week 1 (n = 53, 48, 48, 54, 53)
    -0.5 ± 2.71
    0.0 ± 2.38
    -0.6 ± 2.49
    -0.9 ± 2.94
    -1.0 ± 2.16
        Depression score Week 2 (n = 53, 48, 46, 52, 50)
    -0.5 ± 2.78
    0.4 ± 2.99
    -1.1 ± 1.85
    -1.2 ± 2.93
    -1.8 ± 2.66
        Depression score Week 4 (n = 47, 45, 45, 51, 51)
    -0.5 ± 3.00
    -0.4 ± 3.26
    -0.8 ± 2.05
    -1.5 ± 3.35
    -2.1 ± 3.30
        Depression score Week 8 (n = 41, 36, 42, 46, 50)
    -0.7 ± 3.31
    -1.3 ± 3.76
    -0.9 ± 2.84
    -2.1 ± 3.35
    -1.7 ± 3.08
        Depression score Week 12 (n = 36, 31, 33, 43, 46)
    -0.9 ± 3.96
    -0.9 ± 3.65
    -0.5 ± 2.83
    -2.4 ± 3.74
    -1.8 ± 3.90
        Depression score Week 14 (n = 31, 29, 28, 39, 45)
    0.1 ± 3.41
    -1.2 ± 3.50
    -0.9 ± 1.53
    -1.7 ± 4.31
    -0.1 ± 4.18
        Depression score Week 16 (n = 27, 26, 26, 34, 38)
    -0.7 ± 3.18
    -1.1 ± 3.59
    -1.0 ± 1.85
    -1.4 ± 3.93
    -0.1 ± 3.57
        Anxiety score Week 1 (n = 53, 48, 48, 54, 53)
    -1.0 ± 2.66
    0.2 ± 2.41
    -0.2 ± 2.49
    -1.1 ± 2.26
    -1.2 ± 2.71
        Anxiety score Week 2 (n = 53, 48, 46, 52, 50)
    -1.5 ± 2.87
    -0.4 ± 2.56
    -0.9 ± 2.88
    -1.7 ± 2.81
    -2.4 ± 3.15
        Anxiety score Week 4 (n = 47, 46, 45, 51, 51)
    -1.6 ± 3.18
    -1.0 ± 2.80
    -0.7 ± 2.69
    -1.7 ± 2.95
    -2.4 ± 4.04
        Anxiety score Week 8 (n = 41, 36, 42, 46, 50)
    -1.7 ± 2.33
    -1.6 ± 2.67
    -1.4 ± 3.21
    -2.7 ± 3.44
    -2.5 ± 3.31
        Anxiety score Week 12 (n = 36, 31, 33, 43, 46)
    -2.6 ± 3.01
    -1.5 ± 2.85
    -1.0 ± 3.43
    -2.8 ± 3.71
    -2.5 ± 3.51
        Anxiety score Week 14 (n = 31, 29, 28, 39, 45
    -2.3 ± 3.43
    -1.5 ± 3.17
    -1.4 ± 2.96
    -2.0 ± 3.49
    -1.5 ± 3.93
        Anxiety score Week 16 (n = 27, 26, 26, 34, 38)
    -2.9 ± 3.75
    -2.2 ± 3.38
    -0.7 ± 3.27
    -1.4 ± 3.85
    -1.5 ± 3.10
    Notes
    [23] - "n" represents the number of evaluable subjects at each visit.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 16
    Adverse event reporting additional description
    The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. 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.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    PF-04965842 10mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    PF-04965842 30mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    PF-04965842 100mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    PF-04965842 200mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Serious adverse events
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 49 (4.08%)
    0 / 51 (0.00%)
    3 / 56 (5.36%)
    2 / 55 (3.64%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 49 (2.04%)
    0 / 51 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 49 (2.04%)
    0 / 51 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 49 (0.00%)
    0 / 51 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 49 (0.00%)
    0 / 51 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis exfoliative
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 49 (0.00%)
    0 / 51 (0.00%)
    0 / 56 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Eczema herpeticum
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 49 (0.00%)
    0 / 51 (0.00%)
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 49 (0.00%)
    0 / 51 (0.00%)
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 56 (30.36%)
    18 / 49 (36.73%)
    25 / 51 (49.02%)
    25 / 56 (44.64%)
    27 / 55 (49.09%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 49 (0.00%)
    1 / 51 (1.96%)
    0 / 56 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    0
    2
    0
    3
    Headache
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 49 (4.08%)
    5 / 51 (9.80%)
    5 / 56 (8.93%)
    4 / 55 (7.27%)
         occurrences all number
    2
    2
    5
    6
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 49 (6.12%)
    1 / 51 (1.96%)
    1 / 56 (1.79%)
    5 / 55 (9.09%)
         occurrences all number
    1
    3
    1
    1
    5
    Nausea
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 49 (6.12%)
    3 / 51 (5.88%)
    1 / 56 (1.79%)
    8 / 55 (14.55%)
         occurrences all number
    1
    4
    5
    1
    9
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    6 / 56 (10.71%)
    8 / 49 (16.33%)
    9 / 51 (17.65%)
    7 / 56 (12.50%)
    7 / 55 (12.73%)
         occurrences all number
    9
    9
    9
    7
    7
    Dermatitis contact
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 49 (0.00%)
    0 / 51 (0.00%)
    3 / 56 (5.36%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 49 (6.12%)
    5 / 51 (9.80%)
    3 / 56 (5.36%)
    5 / 55 (9.09%)
         occurrences all number
    5
    3
    5
    4
    5
    Viral upper respiratory tract infection
         subjects affected / exposed
    5 / 56 (8.93%)
    5 / 49 (10.20%)
    6 / 51 (11.76%)
    10 / 56 (17.86%)
    7 / 55 (12.73%)
         occurrences all number
    6
    5
    7
    15
    8

    More information

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

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

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

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