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    Clinical Trial Results:
    A Phase 2b Randomized, Double‑Blind, Placebo‑Controlled, Multicenter, Dose‑Ranging Study to Evaluate the Efficacy and Safety Profile of PF‑06651600 With a Partially Blinded Extension Period to Evaluate the Efficacy and Safety of PF‑06651600 and PF‑06700841 in Subjects With Active Non‑Segmental Vitiligo

    Summary
    EudraCT number
    		 2018-001271-20
    Trial protocol
    		 DE   BE   ES   IT  
    Global end of trial date
    05 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jan 2022
    First version publication date
    27 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B7981019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03715829
    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
    15 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the efficacy of ritlecitinib dose/dosing regimens at Week 24 in adult participants with active non-segmental vitiligo. • To evaluate the safety and tolerability of ritlecitinib over time in adult participants with active non-segmental vitiligo. • To evaluate the safety and tolerability of ritlecitinib and brepocitinib in adult participants with active non-segmental vitiligo.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Nov 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 21
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Canada: 105
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Japan: 23
    Country: Number of subjects enrolled
    Korea, Republic of: 16
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Taiwan: 7
    Country: Number of subjects enrolled
    United States: 137
    Worldwide total number of subjects
    364
    EEA total number of subjects
    55
    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)
    355
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 578 subjects were screened for this study; 366 were randomized to treatment and 364 (99.5%) subjects received treatment.

    Period 1
    Period 1 title
    Dose Ranging Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-06651600 200 mg - 50 mg QD
    Arm description
    		 Subjects were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600 200 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Investigational medicinal product name
    PF-06651600 50 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 PF-06651600 100 mg - 50 mg QD
    Arm description
    		 Subjects were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF06651600 50 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Investigational medicinal product name
    PF-06651600 100 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 PF-06651600 50 mg QD
    Arm description
    		 Subjects were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600 50 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 PF-06651600 30 mg QD
    Arm description
    		 Subjects were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600 30 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 PF-06651600 10 mg QD
    Arm description
    		 Subjects were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600 10 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomized to receive placebo for 24 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 swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Number of subjects in period 1
    		PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Started
    65
    67
    67
    50
    49
    66
    Completed
    53
    58
    54
    36
    42
    55
    Not completed
    12
    9
    13
    14
    7
    11
         Consent withdrawn by subject
    8
    4
    3
    9
    2
    3
         Adverse event, non-fatal
    2
    4
    5
    2
    3
    3
         Other
    -
    -
    2
    -
    -
    3
         Medication Error Without Associated Adverse Event
    -
    -
    1
    -
    -
    -
         Lost to follow-up
    2
    -
    1
    1
    1
    2
         No Longer Meets Eligibility Criteria
    -
    -
    1
    -
    1
    -
         Lack of efficacy
    -
    1
    -
    1
    -
    -
         Protocol deviation
    -
    -
    -
    1
    -
    -
    Period 2
    Period 2 title
    Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    In the Extension (EXT) Period, the brepocitinib 60 mg - 30 mg QD group and ritlecitinib 200-50 mg QD+ nbUVB group were open-label; the rest of groups were double-blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Extension (EXT) PF-06700841 60 mg - 30 mg QD
    Arm description
    		 After a 4-week drug holiday, subjects received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm is open label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841 30 mg
    Investigational medicinal product code
    Other name
    brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Investigational medicinal product name
    PF-06700841 60 mg
    Investigational medicinal product code
    Other name
    brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 EXT PF-06651600 200 mg - 50 mg QD + nbUVB
    Arm description
    		 Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for subjects who provided nbUVB consent). Subjects who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm is open label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600 200 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Investigational medicinal product name
    PF-06651600 50 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 EXT PF-06651600 200 mg - 50 mg QD
    Arm description
    		 Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm is double blinded.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600 50 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Investigational medicinal product name
    PF-06651600 200 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 EXT PF-06651600 50 mg QD
    Arm description
    		 Ritlecitinib 50 mg QD for 24 weeks. This arm is double blinded.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600 50 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Arm title
    		 EXT PF-06651600 30 mg QD
    Arm description
    		 Ritlecitinib 30 mg QD of for 24 weeks. This arm is double blinded.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06651600 30 mg
    Investigational medicinal product code
    Other name
    ritlecitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects swallowed the tablet once daily with ambient temperature water to a total volume of approximately 240 mL after breakfast whenever possible.

    Number of subjects in period 2 [1]
    		Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 mg - 50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
    Started
    55
    43
    187
    6
    2
    Completed
    47
    27
    158
    3
    2
    Not completed
    8
    16
    29
    3
    0
         Consent withdrawn by subject
    3
    3
    12
    3
    -
         Adverse event, non-fatal
    3
    1
    6
    -
    -
         Other
    1
    2
    4
    -
    -
         Medication Error Without Associated Adverse Event
    -
    1
    1
    -
    -
         Lost to follow-up
    -
    -
    2
    -
    -
         No Longer Meets Eligibility Criteria
    -
    -
    1
    -
    -
         Lack of efficacy
    1
    9
    2
    -
    -
         Protocol deviation
    -
    -
    1
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all of the participants completing the dose ranging period entered the extension period

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-06651600 200 mg - 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.

    Reporting group title
    PF-06651600 100 mg - 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.

    Reporting group title
    PF-06651600 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 50 mg QD for 24 weeks.

    Reporting group title
    PF-06651600 30 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 30 mg QD for 24 weeks.

    Reporting group title
    PF-06651600 10 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 10 mg QD for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo for 24 weeks.

    Reporting group values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo Total
    Number of subjects
    		 65 67 67 50 49 66 364
    Age Categorical
    Units: Subjects
        < 18 years
    		 0 0 0 0 0 0 0
        18 - 44 years
    		 33 29 33 20 16 30 161
        45 - 64 years
    		 30 37 34 30 31 32 194
        ≥ 65 years
    		 2 1 0 0 2 4 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.37 ( 12.21 ) 44.15 ( 11.15 ) 43.34 ( 10.42 ) 44.74 ( 13.51 ) 46.57 ( 10.03 ) 46.09 ( 11.51 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 30 31 39 28 25 40 193
        Male
    		 35 36 28 22 24 26 171
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 1 0 0 1
        Asian
    		 15 17 17 5 11 21 86
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 3 0 0 4 1 2 10
        White
    		 44 47 45 39 33 38 246
        More than one race
    		 0 1 1 0 2 1 5
        Unknown or Not Reported
    		 3 2 4 1 2 4 16
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 11 9 11 12 7 7 57
        Not Hispanic or Latino
    		 54 58 54 38 41 58 303
        Unknown or Not Reported
    		 0 0 2 0 1 1 4

    End points

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    End points reporting groups
    Reporting group title
    PF-06651600 200 mg - 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.

    Reporting group title
    PF-06651600 100 mg - 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.

    Reporting group title
    PF-06651600 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 50 mg QD for 24 weeks.

    Reporting group title
    PF-06651600 30 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 30 mg QD for 24 weeks.

    Reporting group title
    PF-06651600 10 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 10 mg QD for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo for 24 weeks.
    Reporting group title
    Extension (EXT) PF-06700841 60 mg - 30 mg QD
    Reporting group description
    		 After a 4-week drug holiday, subjects received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm is open label.

    Reporting group title
    EXT PF-06651600 200 mg - 50 mg QD + nbUVB
    Reporting group description
    		 Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for subjects who provided nbUVB consent). Subjects who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm is open label.

    Reporting group title
    EXT PF-06651600 200 mg - 50 mg QD
    Reporting group description
    		 Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm is double blinded.

    Reporting group title
    EXT PF-06651600 50 mg QD
    Reporting group description
    		 Ritlecitinib 50 mg QD for 24 weeks. This arm is double blinded.

    Reporting group title
    EXT PF-06651600 30 mg QD
    Reporting group description
    		 Ritlecitinib 30 mg QD of for 24 weeks. This arm is double blinded.

    Primary: Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period

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    End point title
    		 Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period
    End point description
    Central read F-VASI was assessed based on the facial photographs taken at the site. The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1): F-VASI (central read) = Ʃ [Affected Facial Surface Area]×4×[Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. The higher score of F-VASI signified severer symptoms of non-segmental vitiligo. Percent change from baseline in F-VASI =((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24. Baseline was defined as the last measurement prior to Study Day 18.
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    62
    63
    59
    45
    48
    57
    Units: Percentage
        least squares mean (standard error)
    -21.2 ( 4.13 )
    -21.2 ( 4.16 )
    -18.5 ( 4.44 )
    -14.6 ( 5.47 )
    -3.0 ( 4.65 )
    2.1 ( 4.06 )
    Statistical analysis title
    		 PF-06651600 200mg - 50mg QD vs Placebo
    Comparison groups
    PF-06651600 200 mg - 50 mg QD v Placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -23.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -32.53
         upper limit
    		 -13.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.62
    Notes
    [1] - Hochberg’s step-up procedure was conducted to compare the ritlecitinib 200mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.
    Statistical analysis title
    		 PF-06651600 100 mg - 50 mg QD vs Placebo
    Comparison groups
    PF-06651600 100 mg - 50 mg QD v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -23.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -32.53
         upper limit
    		 -13.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.63
    Notes
    [2] - Hochberg’s step-up procedure was conducted to compare the ritlecitinib 100mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.
    Statistical analysis title
    		 PF-06651600 30 mg QD vs Placebo
    Comparison groups
    PF-06651600 30 mg QD v Placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0068 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -27.77
         upper limit
    		 -5.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.71
    Notes
    [3] - Hochberg’s step-up procedure was conducted to compare the ritlecitinib 30 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.
    Statistical analysis title
    		 PF-06651600 10 mg QD vs Placebo
    Comparison groups
    PF-06651600 10 mg QD v Placebo
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2015 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -15.02
         upper limit
    		 4.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.03
    Notes
    [4] - Hochberg’s step-up procedure was conducted to compare the ritlecitinib 10 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.
    Statistical analysis title
    		 PF-06651600 50 mg QD vs Placebo
    Comparison groups
    PF-06651600 50 mg QD v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0003 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -20.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -30.23
         upper limit
    		 -10.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.84
    Notes
    [5] - Hochberg’s step-up procedure was conducted to compare the ritlecitinib 50 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.

    Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period [6]
    End point description
    AE was any untoward medical occurrence in a subject administered a product; the event did not need to have a causal relationship with the treatment. An AE was considered a TEAE if the event started during the effective duration of treatment. All events started on or after the first dosing day and time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator. The safety analysis population included all subjects who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    65
    67
    67
    50
    49
    66
    Units: Subjects
        Subjects With TEAEs (All-Causality)
    56
    45
    54
    30
    40
    52
        Subjects With TEAEs (Treatment-Related)
    32
    19
    20
    17
    18
    20
        Subjects With SAEs (All-Causality)
    0
    0
    1
    1
    1
    1
        Subjects With SAEs (Treatment-Related)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period

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    End point title
    		 Number of Subjects With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period [7]
    End point description
    An AE was any untoward medical occurrence in a study subject administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 24 (Baseline was defined as the last measurement prior to first dosing [Day 1])
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    65
    67
    67
    50
    49
    66
    Units: Subjects
        Subjects With Anaemia
    0
    0
    0
    0
    0
    0
        Subjects With Neutropenia
    0
    1
    0
    0
    1
    1
        Subjects With Thrombocytopenia
    1
    0
    0
    0
    0
    0
        Subjects With Lymphopenia
    1
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period

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    End point title
    		 Number of Subjects With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period [8]
    End point description
    Subjects had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator. The safety analysis population included all subjects who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 24 (Baseline was defined as the last measurement prior to first dosing [Day 1])
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    65
    67
    67
    50
    49
    66
    Units: Subjects
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period

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    End point title
    		 Number of Subjects With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period [9]
    End point description
    Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin. The safety analysis population included all subjects who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    65
    67
    67
    50
    49
    66
    Units: Subjects
        Bilirubin > 1.5 x upper limit of normal (ULN)
    0
    0
    0
    0
    0
    0
        AST > 2.5 x ULN
    1
    0
    1
    0
    1
    0
        ALT > 2.5 x ULN
    0
    0
    1
    1
    1
    1
    No statistical analyses for this end point

    Primary: Number of Subjects With TEAEs and SAEs - Extension (Ext) Period

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    End point title
    		 Number of Subjects With TEAEs and SAEs - Extension (Ext) Period [10]
    End point description
    AE was any untoward medical occurrence in a subject administered a product; the event did not need to have a causal relationship with the treatment. An AE was considered a TEAE if the event started during the effective duration of treatment. All events started on or after the first dosing day and time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator. The safety analysis population included all subjects who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 mg - 50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
    Number of subjects analysed
    55
    43
    187
    6
    2
    Units: Subjects
        Subjects With All-Causality TEAEs
    38
    32
    119
    3
    2
        Subjects With Treatment-Related TEAEs
    20
    12
    36
    0
    0
        Subjects With All-Causality SAEs
    1
    0
    1
    0
    0
        Subjects With Treatment-Related SAEs
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period

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    End point title
    		 Number of Subjects With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period [11]
    End point description
    An AE was any untoward medical occurrence in a study subject administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 mg - 50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
    Number of subjects analysed
    55
    43
    187
    6
    2
    Units: Subjects
        Subjects With Anemia
    0
    0
    0
    1
    0
        Subjects With Neutropenia
    1
    0
    1
    0
    0
        Subjects With Thrombocytopenia
    0
    0
    0
    0
    0
        Subjects With Lymphopenia
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period

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    End point title
    		 Number of Subjects With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period [12]
    End point description
    Subjects had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator. The safety analysis population included all subjects who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 mg - 50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
    Number of subjects analysed
    55
    43
    187
    6
    2
    Units: Subjects
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period

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    End point title
    		 Number of Subjects With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period [13]
    End point description
    Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin. The safety analysis population included all subjects who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 mg - 50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
    Number of subjects analysed
    55
    42
    186
    6
    2
    Units: Subjects
        Bilirubin > 1.5 x ULN
    0
    0
    0
    0
    0
        AST > 2.5 x ULN
    0
    0
    0
    0
    0
        ALT > 2.5 x ULN
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Central F-VASI75 at Week 24 - DR Period

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    End point title
    		 Proportion of Subjects Achieving Central F-VASI75 at Week 24 - DR Period
    End point description
    This endpoint was the proportion of subjects achieving at least 75% improvement from baseline in central read F-VASI (F-VASI75) at Week 24. A negative percent change from baseline in central read F-VASI signified an improvement. The central read F-VASI75 response rate was analyzed by first treating the missing data (non-COVID-19 related) as non responders and then applying Chan and Zhang exact confidence interval (CI) method at Week 24. Central read F-VASI75=1 if percent change from baseline ≥75; central read F-VASI75=0 if percent change from baseline <75. Percent change from baseline in F-VASI=((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24. Baseline was defined as the last measurement prior to study Day 18.
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    58
    59
    52
    37
    43
    57
    Units: Percentage of Subjects
        number (not applicable)
    12.1
    8.5
    7.7
    2.7
    2.3
    0
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving T-VASI50 at Week 24 - DR Period

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    End point title
    		 Proportion of Subjects Achieving T-VASI50 at Week 24 - DR Period
    End point description
    T-VASI was calculated using a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ[Hand Units]×[Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. This endpoint was the proportion of subjects achieving at least 50% improvement from baseline in T-VASI (T-VASI50) at Week 24. Negative percent change from baseline in T-VASI signified an improvement. Analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    63
    65
    65
    47
    49
    66
    Units: Percentage of Subjects
        number (not applicable)
    7.9
    4.6
    4.6
    10.6
    4.1
    9.1
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in T-VASI at Designated Time Points - DR Period

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    End point title
    		 Percent Change From Baseline in T-VASI at Designated Time Points - DR Period
    End point description
    The total body VASI (T-VASI) was calculated using a formula that included contribution from all 6 body regions (possible range, 0-100) with a modified method: VASI = Ʃ [Hand Units] × [Depigmentation]. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding the feet), and feet. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in T-VASI = ((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage
    least squares mean (standard error)
        Week 4 (n = 64, 66, 64, 50, 47 and 63)
    -2.4 ( 1.51 )
    -3.0 ( 1.50 )
    -2.6 ( 1.50 )
    -5.1 ( 1.72 )
    -2.9 ( 1.76 )
    -1.4 ( 1.52 )
        Week 8 (n = 63, 65, 63, 48, 48, 64)
    -6.2 ( 2.03 )
    -5.4 ( 2.01 )
    -5.1 ( 2.01 )
    -6.6 ( 2.33 )
    -3.0 ( 2.32 )
    -5.8 ( 2.02 )
        Week 12 (n = 59, 62, 60, 44, 46 and 61)
    -7.2 ( 2.44 )
    -11.9 ( 2.40 )
    -9.1 ( 2.40 )
    -11.4 ( 2.82 )
    -4.9 ( 2.76 )
    -8.0 ( 2.40 )
        Week 16 (n = 56, 57, 55, 43, 43 and 58)
    -10.0 ( 2.66 )
    -13.1 ( 2.67 )
    -12.6 ( 2.66 )
    -11.9 ( 3.03 )
    -5.7 ( 3.03 )
    -12.0 ( 2.62 )
        Week 20 (n = 52, 59, 53, 43, 41 and 55)
    -13.8 ( 3.13 )
    -16.0 ( 2.98 )
    -14.2 ( 3.07 )
    -12.0 ( 3.43 )
    -9.2 ( 3.51 )
    -13.3 ( 3.04 )
        Week 24 (n = 52, 58, 52, 36, 41 and 56)
    -14.7 ( 3.49 )
    -19.2 ( 3.29 )
    -14.7 ( 3.44 )
    -14.0 ( 4.15 )
    -12.1 ( 3.88 )
    -11.0 ( 3.34 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period

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    End point title
    		 Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period
    End point description
    Central read F-VASI was assessed based on the facial photographs taken at the site. Central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area]× 4 ×[Depigmentation Rates]. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 16 and 24. Baseline was defined as the last measurement prior to Study Day 18.
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    62
    63
    59
    45
    48
    57
    Units: Percentage
    least squares mean (standard error)
        Week 4 (n = 61, 60, 55, 44, 47 and 56)
    0.1 ( 0.80 )
    0.4 ( 0.82 )
    -0.2 ( 0.84 )
    -1.2 ( 0.94 )
    0.0 ( 0.91 )
    0.6 ( 0.83 )
        Week 8 (n = 57, 57, 52, 43, 47 and 55)
    -7.0 ( 1.42 )
    -5.3 ( 1.44 )
    -1.8 ( 1.46 )
    -1.4 ( 1.62 )
    -0.1 ( 1.55 )
    -0.2 ( 1.44 )
        Week 16 (n = 51, 49, 49, 34, 37 and 47)
    -17.0 ( 3.16 )
    -16.4 ( 3.25 )
    -10.7 ( 3.19 )
    -13.3 ( 3.87 )
    -5.6 ( 3.67 )
    -0.2 ( 3.27 )
        Week 24 (n = 49, 49, 41, 27, 37 and 50)
    -21.2 ( 4.13 )
    -21.2 ( 4.16 )
    -18.5 ( 4.44 )
    -14.6 ( 5.47 )
    -3.0 ( 4.65 )
    2.1 ( 4.06 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period

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    End point title
    		 Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period
    End point description
    Site assessment of the F-VASI was calculated by a formula that included contribution from face (possible range 0 to 4): Local F-VASI=[Digit Units] × [Depigmentation]×0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the subject’s thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the percentages of 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in F-VASI = ((post baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. Negative percent change from baseline in F-VASI signified an improvement. Analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage
    least squares mean (standard error)
        Week 4 (n = 64, 66, 64, 50, 47 and 63)
    -4.9 ( 2.63 )
    3.1 ( 2.61 )
    -5.0 ( 2.60 )
    0.4 ( 2.96 )
    -5.3 ( 3.05 )
    -6.3 ( 2.63 )
        Week 8 (n = 63, 65, 63, 48, 48 and 64)
    -11.3 ( 5.35 )
    0.4 ( 5.32 )
    -8.8 ( 5.30 )
    10.1 ( 6.09 )
    -7.3 ( 6.12 )
    -7.5 ( 5.31 )
        Week 12 (n = 59, 62, 60, 44, 46 and 61)
    -15.9 ( 4.16 )
    -6.5 ( 4.11 )
    -12.2 ( 4.10 )
    -7.1 ( 4.77 )
    -9.8 ( 4.72 )
    -11.4 ( 4.08 )
        Week 16 (n = 56, 57, 56, 43, 44 and 58)
    -19.4 ( 4.85 )
    -6.2 ( 4.88 )
    -19.7 ( 4.82 )
    -6.4 ( 5.48 )
    -10.3 ( 5.46 )
    -13.3 ( 4.75 )
        Week 20 (n = 52, 59, 53, 43, 41 and 55)
    -21.9 ( 5.59 )
    -12.9 ( 5.35 )
    -23.2 ( 5.52 )
    0 ( 6.11 )
    -14.4 ( 6.30 )
    -15.3 ( 5.44 )
        Week 24 (n = 52, 58, 52, 36, 41 and 56)
    -28.3 ( 5.70 )
    -20.6 ( 5.38 )
    -26.2 ( 5.61 )
    -4.3 ( 6.70 )
    -13.9 ( 6.32 )
    -18.1 ( 5.43 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in SA-VES at Designated Time Points - DR Period

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    End point title
    		 Percent Change From Baseline in SA-VES at Designated Time Points - DR Period
    End point description
    The Self-Assessment Vitiligo Extent Score (SA-VES) was a validated patient report outcome measurement instrument to provide information about disease extent. Vitiligo Extent Score (VES) was a measure to express the overall vitiligo involvement of the body (extent). Clinical illustrations for 19 separate body areas that reflected different degrees of involvement (1%, 5%, 10%, 25%, 50% and 75% depigmentation) were chosen to represent the participant’s skin lesions to get the total extent of the disease. VES was a sum of all surface measurement that was similar to VASI. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 16 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage
    least squares mean (standard error)
        Week 4 (n = 62, 66, 64, 50, 47 and 63)
    2.7 ( 17.19 )
    1.1 ( 16.71 )
    -1.1 ( 16.74 )
    4.9 ( 19.25 )
    4.9 ( 19.84 )
    50.4 ( 17.13 )
        Week 16 (n = 54, 55, 56, 41, 44 and 58)
    4.7 ( 13.82 )
    -0.5 ( 13.48 )
    -3.7 ( 13.45 )
    6.9 ( 15.53 )
    -0.5 ( 15.87 )
    52.5 ( 13.72 )
        Week 24 (n = 50, 56, 49, 32, 40 and 55)
    0 ( 10.35 )
    -3.5 ( 10.02 )
    -4.3 ( 10.11 )
    -4.4 ( 11.89 )
    -1.6 ( 11.77 )
    44.0 ( 10.16 )
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period

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    End point title
    		 Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period
    End point description
    The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: VASI = Ʃ [Hand Units] × [Depigmentation]. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding the feet), and feet. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. The absolute change from baseline in T-VASI was analyzed using the ANCOVA analysis. Negative change from baseline in T-VASI signified an improvement. The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Units on a Scale
    least squares mean (standard error)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    -0.3 ( 0.25 )
    -0.5 ( 0.25 )
    -0.6 ( 0.25 )
    -1.0 ( 0.28 )
    -0.4 ( 0.29 )
    -0.2 ( 0.25 )
        Week 8 (n = 63, 65, 63, 48, 48 and 64)
    -0.9 ( 0.32 )
    -0.9 ( 0.32 )
    -0.9 ( 0.32 )
    -1.2 ( 0.37 )
    -0.5 ( 0.36 )
    -0.9 ( 0.32 )
        Week 12 (n = 59, 62, 60, 44, 46 and 61)
    -1.1 ( 0.41 )
    -2.0 ( 0.40 )
    -1.6 ( 0.40 )
    -1.8 ( 0.47 )
    -0.9 ( 0.46 )
    -1.6 ( 0.40 )
        Week 16 (n = 56, 57, 55, 43, 43 and 58)
    -1.5 ( 0.46 )
    -2.1 ( 0.46 )
    -1.9 ( 0.46 )
    -1.9 ( 0.53 )
    -0.9 ( 0.53 )
    -2.2 ( 0.46 )
        Week 20 (n = 52, 59, 53, 43, 41 and 55)
    -2.0 ( 0.55 )
    -2.8 ( 0.53 )
    -2.3 ( 0.54 )
    -2.0 ( 0.61 )
    -1.7 ( 0.62 )
    -2.2 ( 0.54 )
        Week 24 (n = 52, 58, 52, 36, 41 and 56)
    -2.3 ( 0.62 )
    -3.4 ( 0.59 )
    -2.4 ( 0.61 )
    -2.7 ( 0.74 )
    -2.0 ( 0.69 )
    -1.8 ( 0.60 )
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving T-VASI50 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving T-VASI50 at Designated Time Points - DR Period
    End point description
    The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: T-VASI = Ʃ [Hand Units]×[Depigmentation]. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. This endpoint was the proportion of subjects achieving at least 50% improvement from baseline in T-VASI (T-VASI50). Negative percent change from baseline in T-VASI signified an improvement. Percent change from baseline in T-VASI = ((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    1.6
    1.5
    0
    2.0
    0
    0
        Week 8 (n = 64, 67, 67, 50, 49 and 66)
    1.6
    1.5
    1.5
    4.0
    0
    1.5
        Week 12 (n = 62, 66, 66, 49, 48 and 66)
    1.6
    1.5
    1.5
    4.1
    0
    4.5
        Week 16 (n = 63, 62, 66, 47, 46 and 63)
    0
    3.2
    0
    2.1
    0
    6.3
        Week 20 (n = 61, 67, 64, 49, 48 and 63)
    4.9
    1.5
    1.6
    6.1
    2.1
    9.5
        Week 24 (n = 63, 65, 65, 47, 49 and 66)
    7.9
    4.6
    4.6
    10.6
    4.1
    9.1
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving T-VASI75 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving T-VASI75 at Designated Time Points - DR Period
    End point description
    The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: T-VASI = Ʃ [Hand Units]×[Depigmentation]. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. This endpoint was the proportion of subjects achieving at least 75% improvement from baseline in T-VASI (T-VASI75). Negative percent change from baseline in T-VASI signified an improvement. Percent change from baseline in T-VASI = ((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    0
        Week 8 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    0
        Week 12 (n = 62, 66, 66, 49, 48 and 66)
    0
    0
    0
    0
    0
    0
        Week 16 (n = 63, 62, 66, 47, 46 and 63)
    0
    0
    0
    0
    0
    0
        Week 20 (n = 61, 67, 64, 49, 48 and 63)
    0
    0
    0
    0
    0
    0
        Week 24 (n = 63, 65, 65, 47, 49 and 66)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving T-VASI90 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving T-VASI90 at Designated Time Points - DR Period
    End point description
    The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: T-VASI = Ʃ [Hand Units]×[Depigmentation]. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. This endpoint was the proportion of subjects achieving at least 90% improvement from baseline in T-VASI (T-VASI90). Negative percent change from baseline in T-VASI signified an improvement. Percent change from baseline in T-VASI = ((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    0
        Week 8 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    0
        Week 12 (n = 62, 66, 66, 49, 48 and 66)
    0
    0
    0
    0
    0
    0
        Week 16 (n = 63, 62, 66, 47, 46 and 63)
    0
    0
    0
    0
    0
    0
        Week 20 (n = 61, 67, 64, 49, 48 and 63)
    0
    0
    0
    0
    0
    0
        Week 24 (n = 63, 65, 65, 47, 49 and 66)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving T-VASI100 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving T-VASI100 at Designated Time Points - DR Period
    End point description
    The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: T-VASI = Ʃ [Hand Units]×[Depigmentation]. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. This endpoint was the proportion of subjects achieving at least 100% improvement from baseline in T-VASI (T-VASI100). Negative percent change from baseline in T-VASI signified an improvement. Percent change from baseline in T-VASI = ((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    0
        Week 8 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    0
        Week 12 (n = 62, 66, 66, 49, 48 and 66)
    0
    0
    0
    0
    0
    0
        Week 16 (n = 63, 62, 66, 47, 46 and 63)
    0
    0
    0
    0
    0
    0
        Week 20 (n = 61, 67, 64, 49, 48 and 63)
    0
    0
    0
    0
    0
    0
        Week 24 (n = 63, 65, 65, 47, 49 and 66)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Central Read F-VASI50 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving Central Read F-VASI50 at Designated Time Points - DR Period
    End point description
    The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1): F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. This endpoint was the proportion of subjects achieving at least 50% improvement in central read F-VASI from baseline (F-VASI50). Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 16 and 24. Baseline was defined as the last measurement prior to Study Day 18.
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    62
    63
    59
    45
    48
    57
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 62, 63, 59, 45, 48 and 57)
    0
    0
    0
    2.2
    0
    0
        Week 8 (n = 62, 63, 59, 45, 48 and 57)
    3.2
    0
    0
    2.2
    0
    0
        Week 16 (n = 61, 58, 58, 39, 42 and 52)
    14.8
    13.8
    6.9
    10.3
    2.4
    1.9
        Week 24 (n = 58, 59, 52, 37, 43 and 57)
    22.4
    25.4
    15.4
    18.9
    7.0
    1.8
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Central Read F-VASI75 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving Central Read F-VASI75 at Designated Time Points - DR Period
    End point description
    The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1): F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. This endpoint was the proportion of subjects achieving at least 75% improvement in central read F-VASI from baseline (F-VASI75). Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 16 and 24. Baseline was defined as the last measurement prior to Study Day 18.
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    62
    63
    59
    45
    48
    57
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 62, 63, 59, 45, 48 and 57)
    0
    0
    0
    0
    0
    0
        Week 8 (n = 62, 63, 59, 45, 48 and 57)
    0
    0
    0
    0
    0
    0
        Week 16 (n = 61, 58, 58, 39, 42 and 52)
    1.6
    1.7
    5.2
    2.6
    2.4
    0
        Week 24 (n = 58, 59, 52, 37, 43 and 57)
    12.1
    8.5
    7.7
    2.7
    2.3
    0
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Central Read F-VASI90 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving Central Read F-VASI90 at Designated Time Points - DR Period
    End point description
    The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1): F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. This endpoint was the proportion of subjects achieving at least 90% improvement in central read F-VASI from baseline (F-VASI90). Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 16 and 24. Baseline was defined as the last measurement prior to Study Day 18.
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    62
    63
    59
    45
    48
    57
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 62, 63, 59, 45, 48 and 57)
    0
    0
    0
    0
    0
    0
        Week 8 (n = 62, 63, 59, 45, 48 and 57)
    0
    0
    0
    0
    0
    0
        Week 16 (n = 61, 58, 58, 39, 42 and 52)
    0
    0
    1.7
    0
    0
    0
        Week 24 (n = 58, 59, 52, 37, 43 and 57)
    1.7
    0
    3.8
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Central Read F-VASI100 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving Central Read F-VASI100 at Designated Time Points - DR Period
    End point description
    The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1): F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. This endpoint was the proportion of subjects achieving at least 100% improvement in central read F-VASI from baseline (F-VASI100). Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 16 and 24. Baseline was defined as the last measurement prior to Study Day 18.
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    62
    63
    59
    45
    48
    57
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 62, 63, 59, 45, 48 and 57)
    0
    0
    0
    0
    0
    0
        Week 8 (n = 62, 63, 59, 45, 48 and 57)
    0
    0
    0
    0
    0
    0
        Week 16 (n = 61, 58, 58, 39, 42 and 52)
    0
    0
    0
    0
    0
    0
        Week 24 (n = 58, 59, 52, 37, 43 and 57)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Local F-VASI50 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving Local F-VASI50 at Designated Time Points - DR Period
    End point description
    The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. The volar surface of 1 digit (the subject’s thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. This endpoint was the proportion of subjects achieving at least 50% improvement in site assessment F-VASI from baseline (F-VASI50). Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    3.1
    3.0
    1.5
    2.0
    0
    3.0
        Week 8 (n = 64, 67, 67, 50, 49 and 66)
    9.4
    3.0
    4.5
    2.0
    4.1
    4.5
        Week 12 (n = 62, 66, 66, 49, 48 and 66)
    16.1
    9.1
    9.1
    8.2
    8.3
    9.1
        Week 16 (n = 63, 62, 66, 47, 47 and 63)
    14.3
    9.7
    13.6
    8.5
    10.6
    14.3
        Week 20 (n = 61, 67, 64, 49, 48, 63)
    18.0
    14.9
    17.2
    12.2
    16.7
    17.5
        Week 24 (n = 63, 65, 65, 47, 49 and 66)
    20.6
    21.5
    15.4
    10.6
    18.4
    16.7
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Local F-VASI75 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving Local F-VASI75 at Designated Time Points - DR Period
    End point description
    The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. The volar surface of 1 digit (the subject’s thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. This endpoint was the proportion of subjects achieving at least 75% improvement in site assessment F-VASI from baseline (F-VASI75). Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    1.5
        Week 8 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    3.0
    2.0
    0
    0
        Week 12 (n = 62, 66, 66, 49, 48 and 66)
    1.6
    3.0
    4.5
    6.1
    2.1
    1.5
        Week 16 (n = 63, 62, 66, 47, 47 and 63)
    3.2
    0
    4.5
    4.3
    4.3
    7.9
        Week 20 (n = 61, 67, 64, 49, 48 and 63)
    6.6
    1.5
    9.4
    6.1
    6.3
    11.1
        Week 24 (n = 63, 65, 65, 47, 49 and 66)
    11.1
    4.6
    6.2
    4.3
    4.1
    13.6
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Local F-VASI90 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving Local F-VASI90 at Designated Time Points - DR Period
    End point description
    The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. The volar surface of 1 digit (the subject’s thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. This endpoint was the proportion of subjects achieving at least 90% improvement in site assessment F-VASI from baseline (F-VASI90). Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    0
        Week 8 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    1.5
    2.0
    0
    0
        Week 12 (n = 62, 66, 66, 49, 48 and 66)
    0
    0
    1.5
    2.0
    0
    0
        Week 16 (n = 63, 62, 66, 47, 47 and 63)
    1.6
    0
    3.0
    2.1
    2.1
    0
        Week 20 (n = 61, 67, 64, 49, 48 and 63)
    1.6
    1.5
    4.7
    2.0
    2.1
    1.6
        Week 24 (n = 63, 65, 65, 47, 49 and 66)
    1.6
    1.5
    3.1
    0
    4.1
    1.5
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Local F-VASI100 at Designated Time Points - DR Period

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    End point title
    		 Proportion of Subjects Achieving Local F-VASI100 at Designated Time Points - DR Period
    End point description
    The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. The volar surface of 1 digit (the subject’s thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. This endpoint was the proportion of subjects achieving at least 100% improvement in site assessment F-VASI from baseline (F-VASI100). Negative percent change from baseline in F-VASI signified an improvement. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    0
    0
    0
        Week 8 (n = 64, 67, 67, 50, 49 and 66)
    0
    0
    0
    2.0
    0
    0
        Week 12 (n = 62, 66, 66, 49, 48 and 66)
    0
    0
    0
    0
    0
    0
        Week 16 (n = 63, 62, 66, 47, 47 and 63)
    0
    0
    0
    0
    0
    0
        Week 20 (n = 61, 67, 64, 49, 48 and 63)
    0
    0
    1.6
    0
    0
    0
        Week 24 (n = 63, 65, 65, 47, 49 and 66)
    0
    0
    1.5
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Vitiligo-Specific Quality of Life (VitiQoL) Score at Designated Time Points - DR Period

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    End point title
    		 Change From Baseline in Total Vitiligo-Specific Quality of Life (VitiQoL) Score at Designated Time Points - DR Period
    End point description
    The VitiQoL instrument was a reliable and validated vitiligo disease-specific health-related quality of life (HRQoL) instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item patient reported outcomes (PRO) measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from “not at all” (scored 0) to “most of the time” (scored 6) and gave a minimum and maximum score from 0 90, with higher scores representing greater burden. VitiQoL total score was calculated as sum of items 1-15. The change from baseline in total VitiQoL score was analyzed using the mixed-effect models repeated measures (MMRM) analysis. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 16 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Units on a Scale
    least squares mean (standard error)
        Week 4 (n = 62, 66, 64, 50, 47 and 63)
    -3.9 ( 1.34 )
    -2.9 ( 1.31 )
    -4.4 ( 1.31 )
    -4.4 ( 1.50 )
    -3.5 ( 1.54 )
    -5.1 ( 1.33 )
        Week 16 (n = 54, 56, 56, 41, 44 and 59)
    -6.5 ( 1.83 )
    -4.9 ( 1.79 )
    -6.3 ( 1.82 )
    -4.8 ( 2.07 )
    -10.5 ( 2.06 )
    -7.1 ( 1.78 )
        Week 24 (n = 50, 56, 50, 34, 41 and 56)
    -6.5 ( 1.99 )
    -3.6 ( 1.92 )
    -7.7 ( 1.99 )
    -7.0 ( 2.30 )
    -9.7 ( 2.22 )
    -6.4 ( 1.92 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period

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    End point title
    		 Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period
    End point description
    The VitiQoL was a reliable and validated vitiligo disease specific health-related quality of life (HRQoL) instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from “not at all” (scored 0) to “most of the time” (scored 6) and gave a minimum and maximum score from 0 90, with higher scores representing greater burden. The VitiQoL Participation Limitation domain score was the sum of items 3, 4, 6, 9, 10, 11, 14. The change from baseline in VitiQoL Participation Limitation domain score was analyzed using the MMRM analysis. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 16 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Units on a Scale
    least squares mean (standard error)
        Week 4 (n = 62, 66, 64, 50, 47 and 63)
    -1.2 ( 0.71 )
    -1.1 ( 0.69 )
    -1.7 ( 0.69 )
    -1.8 ( 0.79 )
    -1.0 ( 0.81 )
    -2.5 ( 0.70 )
        Week 16 (n = 54, 56, 56, 41, 44 and 59)
    -2.1 ( 0.88 )
    -1.9 ( 0.86 )
    -2.6 ( 0.87 )
    -2.3 ( 1.00 )
    -4.1 ( 0.99 )
    -3.1 ( 0.85 )
        Week 24 (n = 50, 56, 50, 34, 41 and 56)
    -1.4 ( 0.98 )
    -1.7 ( 0.94 )
    -3.2 ( 0.97 )
    -2.8 ( 1.14 )
    -3.9 ( 1.09 )
    -2.2 ( 0.94 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period

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    End point title
    		 Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period
    End point description
    The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from “not at all” (scored 0) to “most of the time” (scored 6) and gave a minimum and maximum score from 0 90, with higher scores representing greater burden. The VitiQoL Stigma domain score was the sum of items 1, 2, 5, 7 and 15. The change from baseline in VitiQoL Stigma domain score was analyzed using the MMRM analysis. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 16 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Units on a Scale
    least squares mean (standard error)
        Week 4 (n = 62, 66, 64, 50, 47 and 63)
    -1.9 ( 0.56 )
    -1.6 ( 0.55 )
    -2.4 ( 0.55 )
    -1.7 ( 0.62 )
    -1.7 ( 0.64 )
    -1.8 ( 0.56 )
        Week 16 (n = 54, 56, 56, 41, 44 and 59)
    -3.4 ( 0.71 )
    -2.3 ( 0.70 )
    -3.2 ( 0.71 )
    -1.7 ( 0.80 )
    -4.3 ( 0.80 )
    -2.9 ( 0.69 )
        Week 24 (n = 50, 56, 50, 34, 41 and 56)
    -3.8 ( 0.76 )
    -2.1 ( 0.73 )
    -3.7 ( 0.76 )
    -3.1 ( 0.88 )
    -4.5 ( 0.84 )
    -3.2 ( 0.73 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period

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    End point title
    		 Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period
    End point description
    The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from “not at all” (scored 0) to “most of the time” (scored 6) and gave a minimum and maximum score from 0 90, with higher scores representing greater burden. The VitiQoL Behaviors domain score was the sum of items 8, 12 and 13. The change from baseline in VitiQoL Behaviors domain score was analyzed using the MMRM analysis. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement. The n in the parentheses below represents the number of evaluable subjects analyzed in each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 16 and 24. Baseline was defined as the last measurement prior to first dosing (Day 1).
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    64
    67
    67
    50
    49
    66
    Units: Units on a Scale
    least squares mean (standard error)
        Week 4 (n = 62, 66, 64, 50, 47 and 63)
    -0.8 ( 0.37 )
    -0.3 ( 0.36 )
    -0.2 ( 0.36 )
    -0.9 ( 0.41 )
    -0.7 ( 0.42 )
    -0.7 ( 0.37 )
        Week 16 (n = 54, 56, 56, 41, 44 and 59)
    -1.1 ( 0.50 )
    -0.8 ( 0.49 )
    -0.5 ( 0.50 )
    -0.9 ( 0.57 )
    -2.1 ( 0.56 )
    -1.0 ( 0.49 )
        Week 24 (n = 50, 56, 50, 34, 41 and 56)
    -1.4 ( 0.53 )
    0 ( 0.52 )
    -0.7 ( 0.53 )
    -1.3 ( 0.62 )
    -1.3 ( 0.60 )
    -0.9 ( 0.51 )
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period

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    End point title
    		 Proportion of Subjects Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period
    End point description
    The proportion of participants achieving a static Investigator Global Assessment (sIGA) Score 0/1 and sIGA ≥2-point improvement at Week 24 was presented in this outcome measure. The sIGA score ranged from 0 to 4. The sIGA Score 0 represented "Clear" with no signs of loss of pigmentation with natural light or with Woods lamp examination. The sIGA Score 1 represented "Almost Clear" with the following descriptors: • Faint, barely detectable loss of pigmentation mainly located on dorsal hands, feet, bony prominences, and/or limited areas. • Approximately 90% pigmentation within lesions. • No or rare signs of Koebner phenomenon, confetti like or trichrome lesions could be present. The sIGA Scores 2, 3 and 4 represented "Mild Vitiligo", "Moderate Vitiligo" and "Severe Vitiligo", respectively. The analysis population included all subjects who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
    Number of subjects analysed
    62
    64
    65
    46
    48
    65
    Units: Percentage of Subjects
        number (not applicable)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48 weeks
    Adverse event reporting additional description
    The same event may appear as both an AE and a 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
    24.0
    Reporting groups
    Reporting group title
    PF-06651600 200 mg - 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks

    Reporting group title
    PF-06651600 100 mg - 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib induction dose (100 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks

    Reporting group title
    PF-06651600 50 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 50 mg QD for 24 weeks

    Reporting group title
    PF-06651600 30 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 30 mg QD for 24 weeks

    Reporting group title
    PF-06651600 10 mg QD
    Reporting group description
    		 Subjects were randomized to receive ritlecitinib 10 mg QD for 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo for 24 weeks

    Reporting group title
    EXT PF-06700841 60 mg - 30 mg QD
    Reporting group description
    		 After a 4-week drug holiday (with no investigational product), subjects received induction dose of PF-06700841 60 mg QD for 4 weeks followed by maintenance dosing of PF-06700841 30 mg QD for 16 weeks. This arm is open label.

    Reporting group title
    EXT PF-06651600 200 mg - 50 mg QD + nbUVB
    Reporting group description
    		 Induction dose of PF-06651600 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by maintenance dosing of PF-06651600 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provide nbUVB consent). Subjects who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm is open label.

    Reporting group title
    EXT PF-06651600 200 mg - 50 mg QD
    Reporting group description
    		 Induction dose of 200 mg QD of PF 06651600 for 4 weeks followed by maintenance dosing of 50 mg QD of PF 06651600 for 20 weeks. This arm is double blinded.

    Reporting group title
    EXT PF-06651600 50 mg QD
    Reporting group description
    		 50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.

    Reporting group title
    EXT PF-06651600 30 mg QD
    Reporting group description
    		 30 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.

    Serious adverse events
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo EXT PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 mg - 50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    1 / 50 (2.00%)
    1 / 49 (2.04%)
    1 / 66 (1.52%)
    1 / 55 (1.82%)
    0 / 43 (0.00%)
    1 / 187 (0.53%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    1 / 187 (0.53%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 50 (0.00%)
    1 / 49 (2.04%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophageal spasm
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 50 (2.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Neurogenic bladder
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    1 / 66 (1.52%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Disseminated varicella zoster virus infection
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    1 / 55 (1.82%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo EXT PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 mg - 50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 65 (47.69%)
    35 / 67 (52.24%)
    32 / 67 (47.76%)
    23 / 50 (46.00%)
    22 / 49 (44.90%)
    37 / 66 (56.06%)
    17 / 55 (30.91%)
    14 / 43 (32.56%)
    46 / 187 (24.60%)
    3 / 6 (50.00%)
    2 / 2 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    1 / 55 (1.82%)
    0 / 43 (0.00%)
    2 / 187 (1.07%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    2
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 65 (9.23%)
    1 / 67 (1.49%)
    2 / 67 (2.99%)
    0 / 50 (0.00%)
    1 / 49 (2.04%)
    1 / 66 (1.52%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    1
    2
    0
    1
    1
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    3 / 55 (5.45%)
    2 / 43 (4.65%)
    3 / 187 (1.60%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    2
    3
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    3 / 50 (6.00%)
    0 / 49 (0.00%)
    1 / 66 (1.52%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    1
    3
    0
    1
    0
    0
    0
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    3 / 55 (5.45%)
    4 / 43 (9.30%)
    3 / 187 (1.60%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    5
    3
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 65 (6.15%)
    7 / 67 (10.45%)
    8 / 67 (11.94%)
    1 / 50 (2.00%)
    4 / 49 (8.16%)
    8 / 66 (12.12%)
    4 / 55 (7.27%)
    3 / 43 (6.98%)
    8 / 187 (4.28%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    9
    8
    2
    5
    10
    4
    3
    8
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 67 (1.49%)
    2 / 67 (2.99%)
    0 / 50 (0.00%)
    1 / 49 (2.04%)
    4 / 66 (6.06%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    3
    0
    1
    4
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 65 (0.00%)
    5 / 67 (7.46%)
    2 / 67 (2.99%)
    4 / 50 (8.00%)
    1 / 49 (2.04%)
    1 / 66 (1.52%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    7
    2
    5
    1
    2
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    3 / 49 (6.12%)
    3 / 66 (4.55%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    4
    3
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    4 / 65 (6.15%)
    1 / 67 (1.49%)
    4 / 67 (5.97%)
    1 / 50 (2.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    4
    1
    0
    0
    0
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    1 / 65 (1.54%)
    4 / 67 (5.97%)
    0 / 67 (0.00%)
    2 / 50 (4.00%)
    1 / 49 (2.04%)
    2 / 66 (3.03%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    4
    0
    2
    1
    2
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    3 / 65 (4.62%)
    2 / 67 (2.99%)
    2 / 67 (2.99%)
    1 / 50 (2.00%)
    2 / 49 (4.08%)
    5 / 66 (7.58%)
    0 / 55 (0.00%)
    3 / 43 (6.98%)
    5 / 187 (2.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    2
    1
    2
    5
    0
    3
    6
    0
    0
    Urticaria
         subjects affected / exposed
    2 / 65 (3.08%)
    3 / 67 (4.48%)
    1 / 67 (1.49%)
    0 / 50 (0.00%)
    3 / 49 (6.12%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    6
    1
    0
    4
    0
    0
    0
    0
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    3 / 43 (6.98%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    1 / 43 (2.33%)
    1 / 187 (0.53%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    3
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 65 (4.62%)
    3 / 67 (4.48%)
    6 / 67 (8.96%)
    0 / 50 (0.00%)
    1 / 49 (2.04%)
    3 / 66 (4.55%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    3
    8
    0
    1
    3
    0
    0
    0
    0
    0
    Spinal segmental dysfunction
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 67 (1.49%)
    1 / 67 (1.49%)
    3 / 50 (6.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    1 / 55 (1.82%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    1
    6
    0
    0
    1
    0
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 67 (1.49%)
    1 / 67 (1.49%)
    1 / 50 (2.00%)
    0 / 49 (0.00%)
    4 / 66 (6.06%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    4
    0
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    3 / 50 (6.00%)
    1 / 49 (2.04%)
    1 / 66 (1.52%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    1
    3
    1
    1
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    8 / 65 (12.31%)
    10 / 67 (14.93%)
    16 / 67 (23.88%)
    5 / 50 (10.00%)
    5 / 49 (10.20%)
    14 / 66 (21.21%)
    3 / 55 (5.45%)
    0 / 43 (0.00%)
    8 / 187 (4.28%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    9
    11
    20
    8
    5
    20
    3
    0
    10
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 65 (7.69%)
    10 / 67 (14.93%)
    5 / 67 (7.46%)
    8 / 50 (16.00%)
    6 / 49 (12.24%)
    8 / 66 (12.12%)
    4 / 55 (7.27%)
    2 / 43 (4.65%)
    9 / 187 (4.81%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    11
    8
    8
    7
    8
    4
    2
    10
    0
    0
    Urinary tract infection
         subjects affected / exposed
    4 / 65 (6.15%)
    4 / 67 (5.97%)
    2 / 67 (2.99%)
    2 / 50 (4.00%)
    3 / 49 (6.12%)
    3 / 66 (4.55%)
    1 / 55 (1.82%)
    3 / 43 (6.98%)
    12 / 187 (6.42%)
    1 / 6 (16.67%)
    1 / 2 (50.00%)
         occurrences all number
    5
    6
    2
    2
    3
    3
    2
    4
    16
    1
    1
    COVID-19
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    2 / 187 (1.07%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    Influenza
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    3 / 55 (5.45%)
    0 / 43 (0.00%)
    2 / 187 (1.07%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    2
    0
    0
    Onychomycosis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 66 (0.00%)
    0 / 55 (0.00%)
    0 / 43 (0.00%)
    0 / 187 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2019
    Updated Schedule of Activities; updated exploratory endpoints; added new non-clinical safety information to Section 1.2.3.1 Nonclinical Safety; emerging data was added demonstrating a drug interaction (DDI) with oral contraceptives containing ethinyl estradiol (EE) in Section 1.2.3.2 Clinical Experience; Section 4.4.1 Contraception Requirements were modified; updated Section 1.2.4 Study Rationale, Section 4 Subject Eligibility Criteria, Section 4.4.1 Contraception Requirements, and Section 4.4 Lifestyle Requirements; updated description of static investigator global assessment (sIGA) in Section 7.4 Clinical Efficacy Assessments; safety adjudication committees were added to Section 9 Data Analysis/Statistical Methods; updated Appendix 10 Country Specific Requirements; minor administrative changes and sentence revisions made throughout the document.
    14 Jun 2019
    updated Schedule of Activities; updated Section 1.2.4.1 PF-06651600 Dose Rationale and Section 4.2 Exclusion Criteria; added definitions of adverse reaction (AR), serious adverse reaction (SAR), and suspected unexpected serious adverse reactions (SUSAR) to Section 8 Adverse Event Reporting; updated Appendix 2 Prohibited Concomitant Medications; minor administrative changes and sentence revisions made throughout the document.
    02 Jul 2019
    Added risk-benefit assessment to Section 1.2.5 Summary of Benefits and Risks; updated Section 4.2 Exclusion Criteria.
    04 Nov 2019
    Added IND number for PF-06700841 to cover page; updated Schedule of Activities; added B7931019 study data and safety information from phase 2 studies to Section 1.2.3.2 Clinical Experience; updated exploratory endpoints; details of Section 7.11.1 Skin Biopsies have been modified; updated Section 7 Assessments and Appendix 2; minor administrative changes and sentence revisions made throughout the document.
    26 Jun 2020
    Updated Schedule of Activities; updated exploratory endpoints; clarification that the site assessment F-VASI will be performed by the investigator(s) was added to Section 7.4.3 Facial Vitiligo Area Scoring Index Site Assessment; the sample size rationale was updated in Section 9.1; the analysis of the primary endpoint and secondary endpoints were updated in Section 9.2; the detail of the analysis was removed from Section 9.5 Safety Analysis during the Dose Ranging Period; added Alternative Measures During Public Emergencies to Appendix 11; minor administrative changes and sentence revisions made throughout the document.

    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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