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    Clinical Trial Results:
    A Phase 2b/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of PF-06651600 in Adult and Adolescent Alopecia Areata (AA) Subjects With 50% or Greater Scalp Hair Loss

    Summary
    EudraCT number
    2018-001714-14
    Trial protocol
    GB   DE   HU   CZ   PL   ES  
    Global end of trial date
    24 Jun 2021

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

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    B7981015
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03732807
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, 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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of PF-06651600 compared to placebo in adult and adolescent alopecia areata (AA) subjects with 50% or greater scalp hair loss on regrowth of lost hair (measured by an absolute severity of alopecia tool (SALT) Score ≤20) at week 24. To evaluate the efficacy of PF-06651600 compared to placebo in adult and adolescent AA subjects with 50% or greater scalp hair loss on regrowth of lost hair (as measured by an absolute SALT Score ≤10) at Week 24 (this objective was utilized as the primary objective for the European Medicines Agency and competent authorities in the Voluntary Harmonisation Procedure countries).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Dec 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: 67
    Country: Number of subjects enrolled
    Chile: 44
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Georgia: 23
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    Argentina: 5
    Country: Number of subjects enrolled
    Canada: 98
    Country: Number of subjects enrolled
    China: 81
    Country: Number of subjects enrolled
    Czechia: 20
    Country: Number of subjects enrolled
    Denmark: 31
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Japan: 47
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Poland: 53
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    Taiwan: 11
    Country: Number of subjects enrolled
    United States: 195
    Worldwide total number of subjects
    718
    EEA total number of subjects
    122
    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)
    105
    Adults (18-64 years)
    593
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The study was conducted in 18 countries from 03 December 2018 to 24 June 2021. A total of 718 subjects were enrolled.

    Pre-assignment
    Screening details
    Total 1097 subjects signed the informed consent form. Out of which 379 subjects were screen failures, 718 actually enrolled into the study and were assigned to study treatments.

    Period 1
    Period 1 title
    Treatment Phase (up to Week 24)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with greater than or equal to (>=) 50 percent (%) hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug .
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 4 of 50 mg tablet of Ritlecitinib once daily for 4 weeks and then 50 mg tablet once daily for next 44 weeks.

    Arm title
    Ritlecitinib (PF-06651600) 200 mg then 30 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 4 of 50 mg tablet of Ritlecitinib once daily for 4 weeks and then 3 of 10 mg tablet once daily for next 44 weeks.

    Arm title
    Ritlecitinib (PF-06651600) 50 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 50 mg tablet of Ritlecitinib once daily for 48 weeks.

    Arm title
    Ritlecitinib (PF-06651600) 30 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 3 of 10 mg tablet of Ritlecitinib once daily for 48 weeks.

    Arm title
    Ritlecitinib (PF-06651600) 10 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 10 mg tablet of Ritlecitinib once daily for 48 weeks.

    Arm title
    Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo, Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo once daily for 24 weeks and then 4 of 50 mg tablet of Ritlecitinib once daily for 4 weeks followed by 50 mg tablet of Ritlecitinib once daily for next 20 weeks.

    Arm title
    Placebo, Ritlecitinib (PF-06651600) 50 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo, Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo once daily for 24 weeks and then 50 mg tablet of Ritlecitinib once daily for next 24 weeks.

    Number of subjects in period 1
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Started
    132
    130
    130
    132
    63
    65
    66
    Completed
    122
    124
    121
    117
    58
    63
    61
    Not completed
    10
    6
    9
    15
    5
    2
    5
         Physician decision
    -
    1
    2
    5
    -
    -
    1
         Pregnancy
    1
    -
    -
    -
    1
    -
    1
         Adverse event
    3
    -
    2
    4
    2
    -
    1
         Lost to follow-up
    1
    -
    1
    2
    1
    -
    -
         Protocol deviation
    1
    1
    -
    -
    -
    -
    -
         Withdrawal by subject
    4
    4
    4
    4
    1
    1
    2
         Lack of efficacy
    -
    -
    -
    -
    -
    1
    -
    Period 2
    Period 2 title
    Treatment Extension (Week 25 up to 48)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >= 50 % hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug .
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 4 of 50 mg tablet of Ritlecitinib once daily for 4 weeks and then 50 mg tablet once daily for next 44 weeks.

    Arm title
    Ritlecitinib (PF-06651600) 200 mg then 30 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 4 of 50 mg tablet of Ritlecitinib once daily for 4 weeks and then 3 of 10 mg tablet once daily for next 44 weeks.

    Arm title
    Ritlecitinib (PF-06651600) 50 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 50 mg tablet of Ritlecitinib once daily for 48 weeks.

    Arm title
    Ritlecitinib (PF-06651600) 30 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 3 of 10 mg tablet of Ritlecitinib once daily for 48 weeks.

    Arm title
    Ritlecitinib (PF-06651600) 10 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 10 mg tablet of Ritlecitinib once daily for 48 weeks.

    Arm title
    Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo, Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo once daily for 24 weeks and then 4 of 50 mg tablet of Ritlecitinib once daily for 4 weeks followed by 50 mg tablet of Ritlecitinib once daily for next 20 weeks.

    Arm title
    Placebo, Ritlecitinib (PF-06651600) 50 mg
    Arm description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo, Ritlecitinib
    Investigational medicinal product code
    PF-06651600
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo once daily for 24 weeks and then 50 mg tablet of Ritlecitinib once daily for next 24 weeks.

    Number of subjects in period 2
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Started
    122
    124
    121
    117
    58
    63
    61
    Completed
    126
    119
    125
    123
    58
    62
    62
    Not completed
    6
    11
    5
    9
    5
    3
    4
         Physician decision
    -
    1
    -
    1
    1
    -
    -
         Adverse event
    -
    2
    2
    1
    -
    -
    2
         Unspecified
    1
    4
    -
    2
    -
    -
    -
         Lost to follow-up
    -
    -
    2
    1
    1
    2
    -
         Non-Compliant with study drug
    -
    1
    -
    -
    -
    -
    -
         Lack of efficacy
    2
    1
    -
    3
    3
    -
    1
         Withdrawal by subject
    3
    2
    1
    1
    -
    1
    1
    Joined
    10
    6
    9
    15
    5
    2
    5
         Other
    10
    6
    9
    15
    5
    2
    5

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with greater than or equal to (>=) 50 percent (%) hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug .

    Reporting group title
    Ritlecitinib (PF-06651600) 200 mg then 30 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 30 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 10 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Placebo, Ritlecitinib (PF-06651600) 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg Total
    Number of subjects
    132 130 130 132 63 65 66 718
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    20 19 18 20 9 10 9 105
        Adults (18-64 years)
    108 110 109 105 54 53 54 593
        From 65-84 years
    4 1 3 7 0 2 3 20
        85 years and over
    0 0 0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    34.5 ( 14.98 ) 33.7 ( 13.75 ) 32.4 ( 13.36 ) 33.7 ( 14.83 ) 34.3 ( 13.88 ) 33.0 ( 14.01 ) 35.0 ( 15.89 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    81 85 71 80 43 46 40 446
        Male
    51 45 59 52 20 19 26 272
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 1 0 2 0 0 0 3
        Asian
    33 28 43 34 17 14 17 186
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 1 0 0 1
        Black or African American
    6 7 5 3 2 2 2 27
        White
    92 90 79 91 42 47 47 488
        More than one race
    0 3 1 2 0 2 0 8
        Unknown or Not Reported
    1 1 2 0 1 0 0 5
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    18 16 11 23 8 7 4 87
        Not Hispanic or Latino
    113 114 116 109 55 58 61 626
        Unknown or Not Reported
    1 0 3 0 0 0 1 5
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Subject analysis sets values
    Placebo
    Number of subjects
    131
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    19
        Adults (18-64 years)
    107
        From 65-84 years
    5
        85 years and over
    0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    34.0 ( 14.96 )
    Sex: Female, Male
    Units: Subjects
        Female
    86
        Male
    45
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    31
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    4
        White
    94
        More than one race
    2
        Unknown or Not Reported
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    11
        Not Hispanic or Latino
    119
        Unknown or Not Reported
    1

    End points

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    End points reporting groups
    Reporting group title
    Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with greater than or equal to (>=) 50 percent (%) hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug .

    Reporting group title
    Ritlecitinib (PF-06651600) 200 mg then 30 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 30 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 10 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Placebo, Ritlecitinib (PF-06651600) 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.
    Reporting group title
    Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >= 50 % hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug .

    Reporting group title
    Ritlecitinib (PF-06651600) 200 mg then 30 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 30 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 10 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Placebo, Ritlecitinib (PF-06651600) 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Primary: Percentage of Subjects With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 10 at Week 24: Analysis 4

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    End point title
    Percentage of Subjects With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 10 at Week 24: Analysis 4 [1]
    End point description
    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this endpoint, percentage of subjects with SALT score less than or equal to (<=) 10 at week 24 were reported. Full analysis set (FAS) included all subjects who were randomised, regardless of whether they received study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint. Analysis 4: Data imputed by using a missing at random (MAR) mechanism for subjects with missing data due to COVID-19. Missing data due to reasons not related to COVID-19 were consider as non-responders.
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    118
    119
    119
    114
    55
    125
    Units: Percentage of subjects
        number (not applicable)
    21.29
    12.87
    13.42
    10.62
    1.65
    1.54
    Statistical analysis title
    Ritlecitinib 200mg then 50mg versus Placebo
    Statistical analysis description
    A generalised linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analysed using the Miettinen and Nurminen method as the analysis model.
    Comparison groups
    Ritlecitinib (PF-06651600) 200 mg then 50 mg v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    19.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.91
         upper limit
    27.59
    Statistical analysis title
    Ritlecitinib 200mg then 30mg versus Placebo
    Statistical analysis description
    A generalised linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analysed using the Miettinen and Nurminen method as the analysis model.
    Comparison groups
    Ritlecitinib (PF-06651600) 200 mg then 30 mg v Placebo
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.000526
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    11.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.93
         upper limit
    17.74
    Statistical analysis title
    Ritlecitinib 50 mg versus Placebo
    Statistical analysis description
    A generalised linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analysed using the Miettinen and Nurminen method as the analysis model.
    Comparison groups
    Ritlecitinib (PF-06651600) 50 mg v Placebo
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.000311
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    11.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.42
         upper limit
    18.33
    Statistical analysis title
    Ritlecitinib 30 mg versus Placebo
    Statistical analysis description
    A generalised linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analysed using the Miettinen and Nurminen method as the analysis model.
    Comparison groups
    Ritlecitinib (PF-06651600) 30 mg v Placebo
    Number of subjects included in analysis
    239
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002922
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    9.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.1
         upper limit
    15.07

    Secondary: Percentage of Subjects With an Absolute SALT Score of Less Than or Equal to 20 at Week 24

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    End point title
    Percentage of Subjects With an Absolute SALT Score of Less Than or Equal to 20 at Week 24 [2]
    End point description
    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this endpoint, percentage of subjects with SALT score <= 20 at week 24 were reported. subjects with missing SALT scores due to coronavirus disease -19 related reasons were excluded from this analysis, while subjects with missing data due to other reasons were considered as non-responders. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    124
    121
    124
    119
    59
    130
    Units: Percentage of Subjects
        number (confidence interval 95%)
    30.65 (22.53 to 38.76)
    22.31 (14.90 to 29.73)
    23.39 (15.94 to 30.84)
    14.29 (8.00 to 20.57)
    1.69 (0.00 to 4.99)
    1.54 (0.00 to 3.65)
    Statistical analysis title
    Ritlecitinib 200mg then 50mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 200 mg then 50 mg v Placebo
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    29.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    21.17
         upper limit
    37.91
    Statistical analysis title
    Ritlecitinib 200mg then 30mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 200 mg then 30 mg v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    20.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.65
         upper limit
    29.18
    Statistical analysis title
    Ritlecitinib 50 mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 50 mg v Placebo
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    21.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.65
         upper limit
    30.23
    Statistical analysis title
    Ritlecitinib 30 mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 30 mg v Placebo
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.000154
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    12.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.69
         upper limit
    20.36

    Secondary: Percentage of Subjects With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1

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    End point title
    Percentage of Subjects With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 [3]
    End point description
    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this endpoint, percentage of subjects with SALT score <= 10 at week 24 were reported. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint. Analysis 1: Subjects with missing SALT score at Week 24 due to COVID-19 related reasons excluded from analysis at that time point, subjects with missing SALT scores due to other reasons counted as non-responders at that time point.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    124
    121
    124
    119
    59
    130
    Units: Percentage of subjects
        number (confidence interval 95%)
    21.77 (14.51 to 29.04)
    13.22 (7.19 to 19.26)
    13.71 (7.66 to 19.76)
    10.92 (5.32 to 16.53)
    1.69 (0.00 to 4.99)
    1.54 (0.00 to 3.65)
    Statistical analysis title
    Ritlecitinib 200mg then 50mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 200 mg then 50 mg v Placebo
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    20.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.23
         upper limit
    28.49
    Statistical analysis title
    Ritlecitinib 200mg then 30mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 200 mg then 30 mg v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.000337
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    11.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.82
         upper limit
    19.07
    Statistical analysis title
    Ritlecitinib 50 mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 50 mg v Placebo
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.000228
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    12.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.27
         upper limit
    19.53
    Statistical analysis title
    Ritlecitinib 30 mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 30 mg v Placebo
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001875
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    9.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.86
         upper limit
    16.46

    Secondary: Percentage of Subjects With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24

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    End point title
    Percentage of Subjects With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 [4]
    End point description
    PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of subject’s AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    120
    119
    120
    116
    55
    125
    Units: Percentage of subjects
        number (not applicable)
    52.19
    45.40
    49.17
    41.95
    11.36
    9.23
    Statistical analysis title
    Ritlecitinib 200 mg then 50 mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 200 mg then 50 mg v Placebo
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    42.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    31.68
         upper limit
    54.25
    Statistical analysis title
    Ritlecitinib 200 mg then 30 mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 200 mg then 30 mg v Placebo
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    36.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    25.22
         upper limit
    47.14
    Statistical analysis title
    Ritlecitinib 50 mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 50 mg v Placebo
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    39.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.85
         upper limit
    51.06
    Statistical analysis title
    Ritlecitinib 30 mg versus Placebo
    Comparison groups
    Ritlecitinib (PF-06651600) 30 mg v Placebo
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Miettinen and Nurminen method
    Parameter type
    Estimate of difference
    Point estimate
    32.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    21.95
         upper limit
    43.5

    Secondary: Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model

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    End point title
    Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model [5]
    End point description
    Exposure response of PF-06651600 on regrowth of scalp hair was characterised using Bayesian three-parameter hyperbolic Emax model for SALT score <=20 at Week 24 with additional term for effect of loading dose. In Emax exposure-response model response function was log odds of percentage of subjects with response based on SALT <=20 at Week 24, which was fit on logistic scale and then back-transformed to percentage. Effect of loading dose is included as fixed factor in model. Variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for remaining groups. SALT is quantitative assessment of AA severity based on scalp hair loss. SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. FAS: all subjects who were randomised, regardless of whether they received study medication. Here, "Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    124
    121
    124
    119
    59
    130
    Units: Percentage of subjects
        number (not applicable)
    32.37
    20.57
    22.52
    13.58
    4.81
    1.63
    No statistical analyses for this end point

    Secondary: Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model

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    End point title
    Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model [6]
    End point description
    Exposure response of PF-06651600 on regrowth of scalp hair was characterised using Bayesian three-parameter hyperbolic Emax model for SALT score <=10 at Week 24 with additional term for effect of loading dose. In Emax exposure-response model response function was log odds of percentage of subjects with response based on SALT <=10 at Week 24, which was fit on logistic scale and then back-transformed to percentage. Effect of loading dose is included as fixed factor in model. Variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for remaining groups. SALT is quantitative assessment of AA severity based on scalp hair loss. SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. FAS: all subjects who were randomised, regardless of whether they received study medication. Here, "Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    124
    121
    124
    119
    59
    130
    Units: Percentage of subjects
        number (not applicable)
    21.29
    13.76
    14.43
    9.02
    3.88
    1.66
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48

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    End point title
    Percentage of Subjects With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48
    End point description
    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point. 99999 signifies that 95% confidence interval (CI) could not be calculated as there were no subjects with SALT score <=20.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 18, 28, 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (n=129, 124, 127, 127, 62, 63, 66)
    0.78 (0.00 to 2.29)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
        Week 8 (n=128, 121, 122, 121, 62, 63, 64)
    5.47 (1.53 to 9.41)
    4.13 (0.59 to 7.68)
    2.46 (0.00 to 5.21)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
        Week 12 (n= 126, 124, 126, 122, 59, 61, 63)
    11.90 (6.25 to 17.56)
    8.87 (3.87 to 13.88)
    6.35 (2.09 to 10.61)
    3.28 (0.12 to 6.44)
    3.39 (0.00 to 8.01)
    1.64 (0.00 to 4.83)
    1.59 (0.00 to 4.67)
        Week 18 (n= 121, 121, 122, 117, 60, 60, 62)
    19.83 (12.73 to 26.94)
    13.22 (7.19 to 19.26)
    13.11 (7.12 to 19.10)
    9.40 (4.11 to 14.69)
    3.33 (0.00 to 7.88)
    1.67 (0.00 to 4.91)
    1.61 (0.00 to 4.75)
        Week 28 (n= 120, 119, 119, 122, 60, 57, 63)
    34.17 (25.68 to 42.65)
    23.53 (15.91 to 31.15)
    26.05 (18.16 to 33.94)
    20.49 (13.33 to 27.65)
    5.00 (0.00 to 10.51)
    1.75 (0.00 to 5.16)
    6.35 (0.33 to 12.37)
        Week 34 (n= 125, 123, 124, 122, 59, 61,65)
    38.40 (29.87 to 46.93)
    27.64 (19.74 to 35.55)
    33.87 (25.54 to 42.20)
    28.69 (20.66 to 36.71)
    5.08 (0.00 to 10.69)
    19.67 (9.70 to 29.65)
    9.23 (2.19 to 16.27)
        Week 40 (n= 128, 123, 122, 120, 59, 65, 65)
    39.06 (30.61 to 47.51)
    33.33 (25.00 to 41.66)
    39.34 (30.68 to 48.01)
    30.00 (21.80 to 38.20)
    6.78 (0.36 to 13.19)
    23.08 (12.83 to 33.32)
    15.38 (6.61 to 24.16)
        Week 48 (n= 129, 122, 125, 122, 61, 65, 64)
    39.53 (31.10 to 47.97)
    34.43 (26.00 to 42.86)
    43.20 (34.52 to 51.88)
    31.15 (22.93 to 39.37)
    9.84 (2.36 to 17.31)
    33.85 (22.34 to 45.35)
    18.75 (9.19 to 28.31)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48

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    End point title
    Percentage of Subjects With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48
    End point description
    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this endpoint, percentage of subjects with SALT score <=10 were reported. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point. 99999 signifies that 95% CI could not be calculated as there were no subjects with SALT score <=10.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 18, 28, 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (n=129, 124, 127, 127, 62, 63, 66)
    0.78 (0.00 to 2.29)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
        Week 8 (n=128, 121, 122, 121, 62, 63, 64)
    2.34 (0.00 to 4.96)
    0.83 (0.00 to 2.44)
    0.82 (0.00 to 2.42)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
        Week 12 (n=126, 124, 126, 122, 59, 61, 63)
    6.35 (2.09 to 10.61)
    5.65 (1.58 to 9.71)
    5.56 (1.56 to 9.56)
    0.82 (0.00 to 2.42)
    1.69 (0.00 to 4.99)
    0.00 (-99999 to 99999)
    1.59 (0.00 to 4.67)
        Week 18 (n=121, 121, 122, 117, 60, 60, 62)
    12.40 (6.52 to 18.27)
    7.44 (2.76 to 12.11)
    6.56 (2.16 to 10.95)
    5.13 (1.13 to 9.12)
    1.67 (0.00 to 4.91)
    1.67 (0.00 to 4.91)
    1.61 (0.00 to 4.75)
        Week 28 (n=120, 119, 119, 122, 60, 57, 63)
    29.17 (21.03 to 37.30)
    16.81 (10.09 to 23.53)
    18.49 (11.51 to 25.46)
    16.39 (9.82 to 22.96)
    3.33 (0.00 to 7.88)
    1.75 (0.00 to 5.16)
    3.17 (0.00 to 7.50)
        Week 34 (n=125, 123, 124, 122, 59, 61, 65)
    30.40 (22.34 to 38.46)
    18.70 (11.81 to 25.59)
    23.39 (15.94 to 30.84)
    22.13 (14.76 to 29.50)
    3.39 (0.00 to 8.01)
    13.11 (4.64 to 21.59)
    4.62 (0.00 to 9.72)
        Week 40 (n=128, 123, 122, 120, 59, 65, 65)
    31.25 (23.22 to 39.28)
    25.20 (17.53 to 32.88)
    27.05 (19.17 to 34.93)
    25.00 (17.25 to 32.75)
    3.39 (0.00 to 8.01)
    18.46 (9.03 to 27.89)
    9.23 (2.19 to 16.27)
        Week 48 (n=129, 122, 125, 122, 61, 65, 64)
    33.33 (25.20 to 41.47)
    27.87 (19.91 to 35.82)
    31.20 (23.08 to 39.32)
    25.41 (17.68 to 33.14)
    6.56 (0.35 to 12.77)
    24.62 (14.14 to 35.09)
    14.06 (5.55 to 22.58)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

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    End point title
    Percentage of Subjects With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
    End point description
    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point. 99999 signifies that CI could not be calculated as there were no subjects with at least 75% improvement in SALT score.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (n=129, 124, 127, 127, 62, 63, 66)
    0.78 (0.00 to 2.29)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
        Week 8 (n=128, 121, 122, 121, 62, 63, 64)
    4.69 (1.03 to 8.35)
    3.31 (0.12 to 6.49)
    1.64 (0.00 to 3.89)
    0.83 (0.00 to 2.44)
    0.00 (-99999 to 99999)
    1.59 (0.00 to 4.67)
    0.00 (-99999 to 99999)
        Week 12 (n=126, 124, 126, 122, 59, 61, 63)
    11.90 (6.25 to 17.56)
    8.06 (3.27 to 12.86)
    6.35 (2.09 to 10.61)
    2.46 (0.00 to 5.21)
    1.69 (0.00 to 4.99)
    1.64 (0.00 to 4.83)
    1.59 (0.00 to 4.67)
        Week 18 (n=121, 121, 122, 117, 60, 60, 62)
    20.66 (13.45 to 27.88)
    14.88 (8.54 to 21.22)
    9.84 (4.55 to 15.12)
    11.11 (5.42 to 16.81)
    1.67 (0.00 to 4.91)
    1.67 (0.00 to 4.91)
    1.61 (0.00 to 4.75)
        Week 24 (n=124, 121, 124, 119, 59, 65, 65)
    31.45 (23.28 to 39.62)
    20.66 (13.45 to 27.88)
    22.58 (15.22 to 29.94)
    13.45 (7.32 to 19.57)
    1.69 (0.00 to 4.99)
    1.54 (0.00 to 4.53)
    3.08 (0.00 to 7.28)
        Week 28 (n=120, 119, 119, 122, 60, 57, 63)
    34.17 (25.68 to 42.65)
    24.37 (16.66 to 32.08)
    27.73 (19.69 to 35.77)
    21.31 (14.04 to 28.58)
    5.00 (0.00 to 10.51)
    3.51 (0.00 to 8.29)
    4.76 (0.00 to 10.02)
        Week 34 (n=125, 123, 124, 122, 59, 61, 65)
    38.40 (29.87 to 46.93)
    32.52 (24.24 to 40.80)
    38.71 (30.14 to 47.28)
    28.69 (20.66 to 36.71)
    5.08 (0.00 to 10.69)
    21.31 (11.03 to 31.59)
    10.77 (3.23 to 18.31)
        Week 40 (n=128, 123, 122, 120, 59, 65, 65)
    39.84 (31.36 to 48.33)
    34.96 (26.53 to 43.39)
    42.62 (33.85 to 51.40)
    30.00 (21.80 to 38.20)
    5.08 (0.00 to 10.69)
    23.08 (12.83 to 33.32)
    15.38 (6.61 to 24.16)
        Week 48 (n=129, 122, 125, 122, 61, 65, 64)
    39.53 (31.10 to 47.97)
    36.07 (27.54 to 44.59)
    46.40 (37.66 to 55.14)
    31.15 (22.93 to 39.37)
    9.84 (2.36 to 17.31)
    32.31 (20.94 to 43.68)
    21.88 (11.75 to 32.00)
    No statistical analyses for this end point

    Secondary: Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24

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    End point title
    Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 [7]
    End point description
    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 4, 8, 12, 18, and 24
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    132
    130
    130
    132
    63
    131
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 4 (n= 127, 121, 124, 124, 58, 127)
    -2.3 (-3.64 to -1.01)
    -2.7 (-4.03 to -1.35)
    -1.8 (-3.16 to -0.50)
    -1.3 (-2.60 to 0.06)
    -1.3 (-3.19 to 0.69)
    -0.9 (-2.17 to 0.46)
        Change at Week 8 (n= 124, 119, 117, 115, 57, 124)
    -12.8 (-15.56 to -10.05)
    -12.5 (-15.28 to -9.71)
    -6.3 (-9.10 to -3.50)
    -5.0 (-7.82 to -2.21)
    -1.7 (-5.74 to 2.34)
    -1.2 (-3.99 to 1.50)
        Change at Week 12 (n= 121, 120, 121, 115, 56, 122)
    -22.7 (-26.47 to -18.97)
    -20.1 (-23.87 to -16.30)
    -12.4 (-16.18 to -8.61)
    -10.3 (-14.11 to -6.47)
    -3.5 (-9.00 to 1.98)
    -2.4 (-6.12 to 1.35)
        Change at Week 18 (n= 117, 119, 117, 112, 56, 119)
    -31.2 (-35.63 to -26.83)
    -25.0 (-29.41 to -20.55)
    -22.5 (-26.94 to -18.07)
    -17.5 (-22.02 to -13.02)
    -2.4 (-8.87 to 3.97)
    -3.9 (-8.31 to 0.43)
        Change at Week 24 (n= 118, 119, 119, 114, 55, 125)
    -36.5 (-41.54 to -31.53)
    -29.2 (-34.21 to -24.15)
    -33.3 (-38.33 to -28.25)
    -23.6 (-28.72 to -18.45)
    -4.2 (-11.50 to 3.13)
    -5.1 (-10.03 to -0.13)
    No statistical analyses for this end point

    Secondary: Change From Baseline in SALT Score at Week 28, 34, 40, and 48

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    End point title
    Change From Baseline in SALT Score at Week 28, 34, 40, and 48
    End point description
    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 28, 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=132,130,130,132,63,65,66)
    90.3 ( 15.05 )
    90.5 ( 14.28 )
    90.3 ( 14.69 )
    90.0 ( 15.07 )
    88.3 ( 16.87 )
    94.4 ( 9.31 )
    91.5 ( 13.22 )
        Change at Week 28 (n=109,113,111,115,55,54,59)
    -44.1 ( 36.35 )
    -33.3 ( 33.85 )
    -36.1 ( 33.42 )
    -29.2 ( 32.56 )
    -5.6 ( 23.15 )
    -11.5 ( 22.75 )
    -5.0 ( 18.51 )
        Change at Week 34 (n=113,118,117,115,54,59,61)
    -48.2 ( 36.16 )
    -35.5 ( 35.50 )
    -43.6 ( 34.35 )
    -33.5 ( 35.01 )
    -7.6 ( 23.61 )
    -27.5 ( 32.78 )
    -12.6 ( 24.47 )
        Change at Week 40 (n= 116,118,113,109,54,61, 60)
    -49.3 ( 36.11 )
    -38.5 ( 37.14 )
    -46.9 ( 35.68 )
    -35.9 ( 35.90 )
    -11.4 ( 26.01 )
    -36.5 ( 34.56 )
    -23.0 ( 30.64 )
        Change at Week 48 (n=114,112,16,107,53,60,59)
    -49.4 ( 36.09 )
    -40.5 ( 37.27 )
    -48.9 ( 36.63 )
    -40.1 ( 35.87 )
    -13.3 ( 30.13 )
    -46.3 ( 35.51 )
    -32.2 ( 32.39 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Subjects Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

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    End point title
    Percentage of Subjects With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Subjects Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
    End point description
    EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point. 99999 signifies that 95% CI could not be calculated as there were no subjects with at least a 2-grade improvement or a score of 3 in EBA.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (n= 107, 104, 104, 107, 51, 53, 52)
    1.87 (0.00 to 4.44)
    2.88 (0.00 to 6.10)
    0.00 (-99999 to 99999)
    0.93 (0.00 to 2.76)
    1.96 (0.00 to 5.77)
    0.00 (-99999 to 99999)
    3.85 (0.00 to 9.07)
        Week 8 (n= 107, 101, 101, 102, 52, 53, 51)
    10.28 (4.53 to 16.03)
    13.86 (7.12 to 20.60)
    2.97 (0.00 to 6.28)
    4.90 (0.71 to 9.09)
    3.85 (0.00 to 9.07)
    3.77 (0.00 to 8.90)
    0.00 (-99999 to 99999)
        Week 12 (n= 105, 103, 104, 105, 48, 51, 50)
    22.86 (14.83 to 30.89)
    17.48 (10.14 to 24.81)
    9.62 (3.95 to 15.28)
    7.62 (2.54 to 12.69)
    6.25 (0.00 to 13.10)
    0.00 (-99999 to 99999)
    4.00 (0.00 to 9.43)
        Week 18 (n= 101, 101, 101, 101, 49, 50, 49)
    29.70 (20.79 to 38.61)
    18.81 (11.19 to 26.43)
    17.82 (10.36 to 25.29)
    12.87 (6.34 to 19.40)
    10.20 (1.73 to 18.68)
    0.00 (-99999 to 99999)
    8.16 (0.50 to 15.83)
        Week 24 (n= 103, 102, 100, 102, 48, 55, 52)
    33.98 (24.83 to 43.13)
    25.49 (17.03 to 33.95)
    29.00 (20.11 to 37.89)
    16.67 (9.43 to 23.90)
    8.33 (0.51 to 16.15)
    3.64 (0.00 to 8.58)
    5.77 (0.00 to 12.11)
        Week 28 (n= 100, 100, 99, 105, 49, 48, 50)
    37.00 (27.54 to 46.46)
    29.00 (20.11 to 37.89)
    27.27 (18.50 to 36.05)
    24.76 (16.51 to 33.02)
    12.24 (3.07 to 21.42)
    4.17 (0.00 to 9.82)
    6.00 (0.00 to 12.58)
        Week 34 (n= 104, 104, 101, 105, 48, 51, 52)
    41.35 (31.88 to 50.81)
    30.77 (21.90 to 39.64)
    34.65 (25.37 to 43.93)
    31.43 (22.55 to 40.31)
    14.58 (4.60 to 24.57)
    15.69 (5.71 to 25.67)
    13.46 (4.18 to 22.74)
        Week 40 (n= 106, 102, 100, 104, 50, 55, 52)
    43.40 (33.96 to 52.83)
    30.39 (21.47 to 39.32)
    39.00 (29.44 to 48.56)
    33.65 (24.57 to 42.74)
    16.00 (5.84 to 26.16)
    20.00 (9.43 to 30.57)
    26.92 (14.87 to 38.98)
        Week 48 (n= 107, 101, 101, 105, 50, 55, 51)
    42.99 (33.61 to 52.37)
    32.67 (23.53 to 41.82)
    43.56 (33.89 to 53.23)
    33.33 (24.32 to 42.35)
    16.00 (5.84 to 26.16)
    30.91 (18.70 to 43.12)
    31.37 (18.64 to 44.11)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Subjects Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

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    End point title
    Percentage of Subjects With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Subjects Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
    End point description
    ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point. 99999 signifies that 95% CI could not be calculated as there were no subjects with at least a 2-grade improvement or a score of 3 in ELA.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (n= 99, 93, 93, 97, 44, 49, 46)
    3.03 (0.00 to 6.41)
    1.08 (0.00 to 3.17)
    5.38 (0.79 to 9.96)
    1.03 (0.00 to 3.04)
    4.55 (0.00 to 10.70)
    2.04 (0.00 to 6.00)
    0.00 (-99999 to 99999)
        Week 8 (n= 99, 90, 91, 92, 45, 49, 45)
    9.09 (3.43 to 14.75)
    4.44 (0.19 to 8.70)
    8.79 (2.97 to 14.61)
    4.35 (0.18 to 8.51)
    2.22 (0.00 to 6.53)
    2.04 (0.00 to 6.00)
    0.00 (-99999 to 99999)
        Week 12 (n= 97, 91, 94, 95, 42, 47, 44)
    16.49 (9.11 to 23.88)
    10.99 (4.56 to 17.41)
    11.70 (5.20 to 18.20)
    7.37 (2.11 to 12.62)
    4.76 (0.00 to 11.20)
    0.00 (-99999 to 99999)
    0.00 (-99999 to 99999)
        Week 18 (n= 94, 90, 90, 91, 43, 46, 43)
    25.53 (16.72 to 34.35)
    20.00 (11.74 to 28.26)
    20.00 (11.74 to 28.26)
    12.09 (5.39 to 18.79)
    6.98 (0.00 to 14.59)
    2.17 (0.00 to 6.39)
    0.00 (-99999 to 99999)
        Week 24 (n= 96, 89, 90, 92, 41, 51, 46)
    30.21 (21.02 to 39.39)
    21.35 (12.84 to 29.86)
    28.89 (19.52 to 38.25)
    26.09 (17.11 to 35.06)
    4.88 (0.00 to 11.47)
    9.80 (1.64 to 17.97)
    0.00 (-99999 to 99999)
        Week 28 (n= 94, 88, 87, 95, 42, 44, 44)
    29.79 (20.54 to 39.03)
    25.00 (15.95 to 34.05)
    36.78 (26.65 to 46.91)
    24.21 (15.60 to 32.82)
    4.76 (0.00 to 11.20)
    6.82 (0.00 to 14.27)
    4.55 (0.00 to 10.70)
        Week 34 (n= 97, 91, 90, 95, 41, 48, 46)
    34.02 (24.59 to 43.45)
    26.37 (17.32 to 35.43)
    38.89 (28.82 to 48.96)
    26.32 (17.46 to 35.17)
    7.32 (0.00 to 15.29)
    16.67 (6.12 to 27.21)
    6.52 (0.00 to 13.66)
        Week 40 (n= 98, 89, 89, 94, 43, 51, 46)
    39.80 (30.10 to 49.49)
    28.09 (18.75 to 37.43)
    38.20 (28.11 to 48.30)
    27.66 (18.62 to 36.70)
    18.60 (6.97 to 30.24)
    25.49 (13.53 to 37.45)
    17.39 (6.44 to 28.34)
        Week 48 (n= 99, 88, 90, 95, 43, 51, 45)
    38.38 (28.80 to 47.96)
    29.55 (20.01 to 39.08)
    40.00 (29.88 to 50.12)
    30.53 (21.27 to 39.79)
    20.93 (8.77 to 33.09)
    37.25 (23.99 to 50.52)
    35.56 (21.57 to 49.54)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48

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    End point title
    Percentage of Subjects With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48
    End point description
    PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of subject’s AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 18, 24, 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (not applicable)
        W4:greatly improved(n=129,124,127,127,62,63,65)
    5.43
    4.03
    2.36
    0
    0
    0
    0
        W4:moderatelyimproved(n=129,124,127,127,62,63,65)
    3.10
    11.29
    4.72
    7.87
    1.61
    1.59
    1.54
        W8:greatly improved(n=128,121,123,121,61,63,64)
    17.19
    14.88
    8.13
    4.13
    1.64
    1.59
    1.56
        W8:moderatelyimproved(n=128,121,123,121,61,63,64)
    13.28
    21.49
    7.32
    16.53
    4.92
    3.17
    4.69
        W12:greatly improved(n=127,124,125,123,59,60,63)
    22.83
    22.58
    13.60
    12.20
    3.39
    0
    3.17
        W12:moderatelyimproved(n=127,124,125,123,59,60,63)
    18.11
    19.35
    14.40
    14.63
    3.39
    10.00
    7.94
        W18:greatly improved(n=123,121,122,119,61,60,61)
    27.64
    22.31
    18.03
    19.33
    1.64
    1.67
    3.28
        W18:moderatelyimproved(n=123,121,22,119,61,60,61)
    23.58
    23.97
    27.87
    15.13
    6.56
    10.00
    4.92
        W24:greatly improved(n=126,121,125,121,60,65,65)
    36.51
    26.45
    28.80
    28.93
    1.67
    1.54
    4.62
        W24:moderatelyimproved(n=126,121,125,121,60,65,65)
    16.67
    20.66
    20.80
    13.22
    10.00
    9.23
    3.08
        W34:greatly improved(n=125,121,123,122,59,59,64)
    43.20
    35.54
    37.40
    31.97
    5.08
    18.64
    7.81
        W34:moderatelyimproved(n=125,121,123,122,59,59,64)
    12.00
    17.36
    15.45
    15.57
    6.78
    22.03
    20.31
        W40:greatly improved(n=128,124,122,120,59,65,65)
    43.75
    34.68
    37.70
    30.00
    6.78
    30.77
    13.85
        W40:moderatelyimproved(n=128,124,122,120,59,65,65)
    15.63
    14.52
    14.75
    19.17
    11.86
    24.62
    15.38
        W48:greatly improved(n=129,123,125,122,61,64,64)
    44.96
    33.33
    42.40
    31.15
    6.56
    42.19
    26.56
        W48:moderatelyimproved(n=129,123,125,122,61,64,64)
    13.18
    18.70
    13.60
    18.03
    9.84
    17.19
    17.19
    No statistical analyses for this end point

    Secondary: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms (ES) and Activity Limitations (AL)

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    End point title
    Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms (ES) and Activity Limitations (AL) [8]
    End point description
    AAPPO scale:11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and analysed separately on scale 0-4(0=no hair loss and 4=complete hair loss). Items 5-8 assessed emotional symptoms. Response were scored from 0=never to 4=always. Items 9-11 assessed activity limitations. Response were scored from 0=not at all to 4=completely. Change from baseline in AAPPO emotional symptoms sub score was calculated as mean of items 5-8(0=never to 4=always),higher scores:more emotional symptoms; Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11(0=not at all to 4=completely),higher scores:more activity limitations. Baseline was defined as pre-dose on Day 1. FAS:subjects randomised, regardless of whether received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 4, 8, 12, 18, and 24
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    132
    130
    130
    132
    63
    131
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 4: ES (n=127,121,123,122,58,124)
    -0.37 (-0.49 to -0.25)
    -0.22 (-0.34 to -0.10)
    -0.33 (-0.45 to -0.21)
    -0.31 (-0.44 to -0.19)
    -0.29 (-0.47 to -0.11)
    -0.28 (-0.40 to -0.16)
        Change at Week 8: ES (n= 122,119,117,115,56,123)
    -0.50 (-0.62 to -0.38)
    -0.46 (-0.58 to -0.34)
    -0.50 (-0.62 to -0.37)
    -0.36 (-0.48 to -0.23)
    -0.45 (-0.62 to -0.27)
    -0.39 (-0.51 to -0.27)
        Change at Week 12: ES (n=122,120,119,116,56,121)
    -0.53 (-0.66 to -0.40)
    -0.54 (-0.67 to -0.41)
    -0.48 (-0.61 to -0.34)
    -0.49 (-0.63 to -0.36)
    -0.50 (-0.69 to -0.31)
    -0.36 (-0.49 to -0.23)
        Change at Week 18: ES (n=118,119,116,114,57,118)
    -0.64 (-0.78 to -0.51)
    -0.57 (-0.71 to -0.44)
    -0.60 (-0.74 to -0.46)
    -0.54 (-0.68 to -0.40)
    -0.44 (-0.63 to -0.24)
    -0.43 (-0.56 to -0.29)
        Change at Week 24: ES (n=120,118,119,116,55,125)
    -0.61 (-0.75 to -0.46)
    -0.61 (-0.76 to -0.47)
    -0.69 (-0.83 to -0.54)
    -0.58 (-0.72 to -0.43)
    -0.49 (-0.70 to -0.28)
    -0.47 (-0.61 to -0.33)
        Change at Week 4: AL (n=127,121,123,122,58,125)
    -0.19 (-0.29 to -0.08)
    -0.04 (-0.15 to 0.07)
    -0.16 (-0.27 to -0.05)
    -0.13 (-0.24 to -0.02)
    -0.20 (-0.36 to -0.04)
    -0.18 (-0.29 to -0.07)
        Change at Week 8: AL (n=122,119,117,115,56,123)
    -0.24 (-0.34 to -0.13)
    -0.25 (-0.36 to -0.14)
    -0.18 (-0.29 to -0.07)
    -0.09 (-0.20 to 0.02)
    -0.21 (-0.37 to -0.05)
    -0.20 (-0.31 to -0.09)
        Change at Week 12: AL (n=122,120,119,116,56,121)
    -0.27 (-0.38 to -0.17)
    -0.22 (-0.32 to -0.11)
    -0.21 (-0.32 to -0.11)
    -0.24 (-0.35 to -0.13)
    -0.27 (-0.42 to -0.11)
    -0.21 (-0.32 to -0.11)
        Change at Week 18: AL (n=118,119,116,114,57,118)
    -0.35 (-0.45 to -0.24)
    -0.26 (-0.36 to -0.15)
    -0.23 (-0.34 to -0.12)
    -0.23 (-0.34 to -0.12)
    -0.28 (-0.44 to -0.13)
    -0.26 (-0.36 to -0.15)
        Change at Week 24: AL (n=120,118,119,115,55,125)
    -0.30 (-0.40 to -0.20)
    -0.30 (-0.40 to -0.20)
    -0.31 (-0.41 to -0.21)
    -0.28 (-0.38 to -0.18)
    -0.31 (-0.45 to -0.16)
    -0.29 (-0.39 to -0.19)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms (ES) and Activity Limitations (AL)

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    End point title
    Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms (ES) and Activity Limitations (AL)
    End point description
    AAPPO scale:11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and analysed separately on scale 0-4(0=no hair loss and 4=complete hair loss). Items 5-8 assessed emotional symptoms. Response were scored from 0=never to 4=always. Items 9-11 assessed activity limitations. Response were scored from 0=not at all to 4=completely. Change from baseline in AAPPO emotional symptoms sub score was calculated as mean of items 5-8(0=never to 4=always),higher scores:more emotional symptoms; Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11(0=not at all to 4=completely),higher scores:more activity limitations. Baseline was defined as pre-dose on Day 1. FAS:subjects randomised, regardless of whether received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 34:ES (n=112,116,114,113,53,57,60)
    -0.78 ( 0.95 )
    -0.72 ( 1.00 )
    -0.72 ( 0.93 )
    -0.71 ( 1.06 )
    -0.62 ( 0.83 )
    -0.77 ( 0.92 )
    -0.64 ( 0.91 )
        Change at Week 40:ES (n= 115,119,112,110,54,62,60)
    -0.84 ( 1.04 )
    -0.80 ( 1.02 )
    -0.81 ( 0.98 )
    -0.83 ( 1.11 )
    -0.62 ( 0.96 )
    -0.83 ( 1.01 )
    -0.66 ( 1.00 )
        Change at Week 48:ES (n=114,112,115,107,53,60,59)
    -0.96 ( 0.99 )
    -0.84 ( 1.07 )
    -0.85 ( 1.04 )
    -0.72 ( 1.15 )
    -0.50 ( 0.89 )
    -0.98 ( 1.05 )
    -0.68 ( 1.03 )
        Change at Week 34:AL (n=112,116,114,115,53,57,60)
    -0.37 ( 0.71 )
    -0.31 ( 0.78 )
    -0.26 ( 0.73 )
    -0.37 ( 0.78 )
    -0.33 ( 0.76 )
    -0.36 ( 0.59 )
    -0.42 ( 0.78 )
        Change at Week 40:AL (n=115,119,112,110,54,62,60)
    -0.44 ( 0.76 )
    -0.33 ( 0.84 )
    -0.25 ( 0.68 )
    -0.42 ( 0.81 )
    -0.23 ( 0.71 )
    -0.40 ( 0.66 )
    -0.39 ( 0.84 )
        Change at Week 48:AL (n=114,112,115,107,53,60,59)
    -0.43 ( 0.79 )
    -0.39 ( 0.84 )
    -0.29 ( 0.76 )
    -0.36 ( 0.85 )
    -0.26 ( 0.90 )
    -0.44 ( 0.71 )
    -0.36 ( 0.81 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48

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    End point title
    Percentage of Subjects With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48
    End point description
    AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss (CHL), eyebrow loss, eyelash loss and body hair loss and were analysed separately on a scale of 0-4, with 0 =‘no hair loss’ and 4=‘complete hair loss’, where higher scores indicated more hair loss. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point. W=week
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 18, 24, 34, 40, and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (confidence interval 95%)
        W4:CHL on scalp (n=123,123,120,124,59,63,63)
    11.38 (5.77 to 16.99)
    9.76 (4.51 to 15.00)
    4.17 (0.59 to 7.74)
    4.84 (1.06 to 8.62)
    1.69 (0.00 to 4.99)
    6.35 (0.33 to 12.37)
    3.17 (0.00 to 7.50)
        W8:CHL on scalp (n=122,120,116,118,58,63,62)
    11.48 (5.82 to 17.13)
    16.67 (10.00 to 23.33)
    7.76 (2.89 to 12.63)
    8.47 (3.45 to 13.50)
    1.72 (0.00 to 5.07)
    4.76 (0.00 to 10.02)
    8.06 (1.29 to 14.84)
        W12: CHL on scalp (n=121,123,118,120,56,60,61)
    20.66 (13.45 to 27.88)
    19.51 (12.51 to 26.52)
    12.71 (6.70 to 18.72)
    13.33 (7.25 to 19.42)
    3.57 (0.00 to 8.43)
    6.67 (0.35 to 12.98)
    4.92 (0.00 to 10.34)
        W18: CHL on scalp (n=117,120,116,116,58,60,59)
    27.35 (19.27 to 35.43)
    25.00 (17.25 to 32.75)
    13.79 (7.52 to 20.07)
    16.38 (9.64 to 23.11)
    8.62 (1.40 to 15.84)
    8.33 (1.34 to 15.33)
    6.78 (0.36 to 13.19)
        W24: CHL on scalp (n=120,120,118,118,57,65,63)
    35.83 (27.25 to 44.41)
    30.00 (21.80 to 38.20)
    26.27 (18.33 to 34.21)
    24.58 (16.81 to 32.34)
    5.26 (0.00 to 11.06)
    10.77 (3.23 to 18.31)
    6.35 (0.33 to 12.37)
        W34: CHL on scalp (n=119,119,116,119,56,59,62)
    42.02 (33.15 to 50.89)
    34.45 (25.92 to 42.99)
    29.31 (21.03 to 37.59)
    30.25 (22.00 to 38.51)
    7.14 (0.40 to 13.89)
    22.03 (11.46 to 32.61)
    11.29 (3.41 to 19.17)
        W40: CHL on scalp (n=122,123,115,117,56,65,63)
    41.80 (33.05 to 50.56)
    36.59 (28.07 to 45.10)
    35.65 (26.90 to 44.41)
    32.48 (23.99 to 40.96)
    8.93 (1.46 to 16.40)
    29.23 (18.17 to 40.29)
    19.05 (9.35 to 28.74)
        W48: CHL on scalp (n=123,122,118,119,58,65,62)
    42.28 (33.55 to 51.01)
    33.61 (25.22 to 41.99)
    42.37 (33.46 to 51.29)
    32.77 (24.34 to 41.21)
    8.62 (1.40 to 15.84)
    33.85 (22.34 to 45.35)
    20.97 (10.83 to 31.10)
        W4: CHL on eyebrows (n=99,98,94,96,46,48,46)
    9.09 (3.43 to 14.75)
    7.14 (2.04 to 12.24)
    7.45 (2.14 to 12.75)
    4.17 (0.17 to 8.16)
    4.35 (0.00 to 10.24)
    6.25 (0.00 to 13.10)
    8.70 (0.55 to 16.84)
        W8:CHL on eyebrows (n=98,95,92,91,46,48,45)
    17.35 (9.85 to 24.84)
    21.05 (12.85 to 29.25)
    11.96 (5.33 to 18.59)
    10.99 (4.56 to 17.41)
    6.52 (0.00 to 13.66)
    4.17 (0.00 to 9.82)
    11.11 (1.93 to 20.29)
        W12: CHL on eyebrows (n=97,97,94,94,43,45,44)
    27.84 (18.92 to 36.75)
    27.84 (18.92 to 36.75)
    18.09 (10.30 to 25.87)
    15.96 (8.55 to 23.36)
    11.63 (2.05 to 21.21)
    11.11 (1.93 to 20.29)
    6.82 (0.00 to 14.27)
        W18: CHL on eyebrows (n=94,95,91,91,45,45,42)
    27.66 (18.62 to 36.70)
    33.68 (24.18 to 43.19)
    27.47 (18.30 to 36.64)
    19.78 (11.60 to 27.96)
    13.33 (3.40 to 23.27)
    11.11 (1.93 to 20.29)
    7.14 (0.00 to 14.93)
        W24: CHL on eyebrows (n=96,94,92,92,44,50,46)
    32.29 (22.94 to 41.65)
    32.98 (23.47 to 42.48)
    30.43 (21.03 to 39.84)
    29.35 (20.04 to 38.65)
    6.82 (0.00 to 14.27)
    12.00 (2.99 to 21.01)
    10.87 (1.87 to 19.86)
        W34: CHL on eyebrows (n=96,93,90,94,43,44,45)
    42.71 (32.81 to 52.60)
    38.71 (28.81 to 48.61)
    38.89 (28.82 to 48.96)
    31.91 (22.49 to 41.34)
    16.28 (5.24 to 27.31)
    22.73 (10.34 to 35.11)
    13.33 (3.40 to 23.27)
        W40: CHL on eyebrows (n=97,95,90,92,45,50,46)
    42.27 (32.44 to 52.10)
    36.84 (27.14 to 46.54)
    38.89 (28.82 to 48.96)
    38.04 (28.12 to 47.96)
    20.00 (8.31 to 31.69)
    32.00 (19.07 to 44.93)
    23.91 (11.59 to 36.24)
        W48: CHL on eyebrows (n=98,94,91,94,45,50,45)
    44.90 (35.05 to 54.75)
    34.04 (24.46 to 43.62)
    43.96 (33.76 to 54.15)
    39.36 (29.49 to 49.24)
    15.56 (4.97 to 26.14)
    38.00 (24.55 to 51.45)
    33.33 (19.56 to 47.11)
        W4: CHL on eyelashes (n=87,87,79,86,38,45,38)
    11.49 (4.79 to 18.20)
    4.60 (0.20 to 9.00)
    7.59 (1.75 to 13.44)
    9.30 (3.16 to 15.44)
    5.26 (0.00 to 12.36)
    8.89 (0.57 to 17.20)
    5.26 (0.00 to 12.36)
        W8: CHL on eyelashes (n=86,85,78,81,38,45,37)
    17.44 (9.42 to 25.46)
    17.65 (9.54 to 25.75)
    12.82 (5.40 to 20.24)
    14.81 (7.08 to 22.55)
    7.89 (0.00 to 16.47)
    6.67 (0.00 to 13.95)
    8.11 (0.00 to 16.90)
        W12: CHL on eyelashes (n=85,86,79,84,36,41,36)
    29.41 (19.73 to 39.10)
    26.74 (17.39 to 36.10)
    16.46 (8.28 to 24.63)
    19.05 (10.65 to 27.44)
    8.33 (0.00 to 17.36)
    14.63 (3.82 to 25.45)
    8.33 (0.00 to 17.36)
        W18:CHL on eyelashes (n=83,85,76,81,38,41,34)
    31.33 (21.35 to 41.30)
    37.65 (27.35 to 47.95)
    21.05 (11.89 to 30.22)
    22.22 (13.17 to 31.28)
    7.89 (0.00 to 16.47)
    12.20 (2.18 to 22.21)
    2.94 (0.00 to 8.62)
        W24: CHL on eyelashes (n=86,83,77,82,36,46,38)
    31.40 (21.59 to 41.20)
    42.17 (31.54 to 52.79)
    31.17 (20.82 to 41.51)
    28.05 (18.33 to 37.77)
    8.33 (0.00 to 17.36)
    13.04 (3.31 to 22.78)
    2.63 (0.00 to 7.72)
        W34: CHL on eyelashes (n=85,82,75,84,35,42,37)
    40.00 (29.59 to 50.41)
    36.59 (26.16 to 47.01)
    37.33 (26.39 to 48.28)
    34.52 (24.36 to 44.69)
    11.43 (0.89 to 21.97)
    21.43 (9.02 to 33.84)
    13.51 (2.50 to 24.53)
        W40: CHL on eyelashes (n=86,84,76,82,37,46,38)
    43.02 (32.56 to 53.49)
    39.29 (28.84 to 49.73)
    32.89 (22.33 to 43.46)
    36.59 (26.16 to 47.01)
    10.81 (0.81 to 20.82)
    28.26 (15.25 to 41.27)
    13.16 (2.41 to 23.91)
        W48: CHL on eyelashes (n=86,83,76,84,37,46,38)
    41.86 (31.43 to 52.29)
    37.35 (26.94 to 47.76)
    38.16 (27.24 to 49.08)
    34.52 (24.36 to 44.69)
    8.11 (0.00 to 16.90)
    39.13 (25.03 to 53.23)
    28.95 (14.53 to 43.37)
        W4: CHL on body (n=96,97,96,94,47,47,44)
    11.46 (5.09 to 17.83)
    9.28 (3.50 to 15.05)
    10.42 (4.31 to 16.53)
    6.38 (1.44 to 11.32)
    2.13 (0.00 to 6.25)
    4.26 (0.00 to 10.03)
    11.36 (1.99 to 20.74)
        W8:CHL on body (n=95,94,93,89,46,47,43)
    14.74 (7.61 to 21.86)
    15.96 (8.55 to 23.36)
    13.98 (6.93 to 21.03)
    10.11 (3.85 to 16.38)
    2.17 (0.00 to 6.39)
    6.38 (0.00 to 13.37)
    11.63 (2.05 to 21.21)
        W12: CHL on body (n=94,94,94,91,45,44,42)
    17.02 (9.42 to 24.62)
    19.15 (11.19 to 27.10)
    14.89 (7.70 to 22.09)
    14.29 (7.10 to 21.48)
    4.44 (0.00 to 10.47)
    11.36 (1.99 to 20.74)
    7.14 (0.00 to 14.93)
        W18: CHL on body (n=91,92,93,88,47,44,40)
    19.78 (11.60 to 27.96)
    25.00 (16.15 to 33.85)
    15.05 (7.79 to 22.32)
    15.91 (8.27 to 23.55)
    10.64 (1.82 to 19.45)
    9.09 (0.60 to 17.59)
    7.50 (0.00 to 15.66)
        W24: CHL on body (n=93,93,93,90,45,49,44)
    25.81 (16.91 to 34.70)
    27.96 (18.84 to 37.08)
    20.43 (12.24 to 28.62)
    22.22 (13.63 to 30.81)
    6.67 (0.00 to 13.95)
    16.33 (5.98 to 26.68)
    11.36 (1.99 to 20.74)
        W34: CHL on body (n=93,92,92,92,44,44,43)
    33.33 (23.75 to 42.91)
    33.70 (24.04 to 43.35)
    31.52 (22.03 to 41.02)
    26.09 (17.11 to 35.06)
    11.36 (1.99 to 20.74)
    22.73 (10.34 to 35.11)
    9.30 (0.62 to 17.98)
        W40: CHL on body (n=94,94,91,90,46,49,44)
    35.11 (25.46 to 44.76)
    36.17 (26.46 to 45.88)
    30.77 (21.29 to 40.25)
    25.56 (16.54 to 34.57)
    8.70 (0.55 to 16.84)
    22.45 (10.77 to 34.13)
    11.36 (1.99 to 20.74)
        W48: CHL on body (n=95,93,93,92,46,49,44)
    34.74 (25.16 to 44.31)
    34.41 (24.75 to 44.06)
    36.56 (26.77 to 46.35)
    30.43 (21.03 to 39.84)
    10.87 (1.87 to 19.86)
    34.69 (21.37 to 48.02)
    20.45 (8.54 to 32.37)
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24

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    End point title
    Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 [9]
    End point description
    HADS: validated 14-item PRO measure assess states of anxiety and depression over past week. Items rated on 4-point severity scale. HADS produces 2 scales, 1 each for anxiety(HADS–A) and depression(HADS–D), differentiating two states with established normal score cut-offs. Instrument have been validated for use by adolescents >=12 years. Each subscale comprised of 7 items and subject responds how each item applies to him/her over past week prior to baseline visit, on 4point response scale. Separate scores calculated for anxiety and depression with score ranges from 0 (no presence of anxiety/depression) to 3 (severe feeling of anxiety/depression). Total score range was from 0-21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1), Week 4, 8, 12, and 24
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    132
    130
    130
    132
    63
    131
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 4 (n= 126, 120, 123, 121, 58, 125)
    -0.1 (-0.54 to 0.26)
    -0.4 (-0.82 to -0.01)
    -0.1 (-0.48 to 0.33)
    -0.1 (-0.48 to 0.33)
    -0.3 (-0.86 to 0.32)
    -0.3 (-0.73 to 0.07)
        Change at Week 8 (n= 124, 119, 118, 114, 56, 124)
    -0.5 (-0.89 to -0.06)
    -0.3 (-0.71 to 0.12)
    -0.2 (-0.58 to 0.26)
    0.2 (-0.25 to 0.59)
    -0.2 (-0.79 to 0.43)
    -0.3 (-0.73 to 0.10)
        Change at Week 12 (n= 121, 119, 119, 114, 56, 120)
    -0.6 (-1.04 to -0.21)
    -0.4 (-0.81 to 0.03)
    0.0 (-0.45 to 0.39)
    0.1 (-0.32 to 0.53)
    -0.5 (-1.07 to 0.15)
    -0.1 (-0.53 to 0.30)
        Change at Week 24 (n= 120, 118, 120, 116, 56, 124)
    -0.4 (-0.79 to 0.07)
    -0.8 (-1.21 to -0.35)
    -0.3 (-0.70 to 0.16)
    -0.2 (-0.66 to 0.21)
    -0.4 (-1.04 to 0.21)
    0.0 (-0.46 to 0.39)
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 48

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    End point title
    Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 48
    End point description
    HADS: validated 14-item PRO measure assess states of anxiety and depression over past week. Items rated on 4-point severity scale. HADS produces 2 scales, 1 each for anxiety(HADS–A) and depression(HADS–D), differentiating two states with established normal score cut-offs. Instrument have been validated for use by adolescents >=12 years. Each subscale comprised of 7 items and subject responds how each item applies to him/her over past week prior to baseline visit, on 4-point response scale. Separate scores calculated for anxiety and depression with score ranges from 0 (no presence of anxiety/depression) to 3 (severe feeling of anxiety/depression). Total score range was from 0-21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1), Week 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 131,130, 130, 131, 63, 65, 66)
    2.7 ( 2.60 )
    3.0 ( 3.16 )
    2.9 ( 3.00 )
    2.8 ( 2.99 )
    2.8 ( 2.80 )
    3.2 ( 3.36 )
    3.3 ( 3.54 )
        Change at Week 48(n=118,118,117,111,55,59,60)
    -0.7 ( 2.13 )
    -0.4 ( 3.15 )
    -0.3 ( 2.67 )
    -0.6 ( 2.44 )
    -0.5 ( 2.53 )
    -0.9 ( 3.25 )
    -0.4 ( 3.28 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24

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    End point title
    Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 [10]
    End point description
    HADS: validated 14-item PRO measure assess states of anxiety and depression over past week. Items rated on 4-point severity scale. HADS produces 2 scales, 1 each for anxiety(HADS–A) and depression(HADS–D), differentiating two states with established normal score cut-offs. Instrument have been validated for use by adolescents >=12 years. Each subscale comprised of 7 items and subject responds how each item applies to him/her over past week prior to baseline visit, on 4-point response scale. Separate scores calculated for anxiety and depression with score ranges from 0 (no presence of anxiety/depression) to 3 (severe feeling of anxiety/depression). Total score range was from 0-21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1), Week 4, 8, 12, and 24
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics were planned only for the arms specified
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo
    Number of subjects analysed
    132
    130
    130
    132
    63
    131
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 4 (n= 125, 119, 123, 121, 58, 125)
    -0.3 (-0.78 to 0.08)
    -0.4 (-0.79 to 0.08)
    -0.4 (-0.79 to 0.08)
    -0.5 (-0.97 to -0.10)
    -0.6 (-1.25 to 0.02)
    -0.1 (-0.54 to 0.32)
        Change at Week 8 (n= 123, 119, 118, 114, 56, 123)
    -0.8 (-1.25 to -0.31)
    -0.4 (-0.88 to 0.07)
    -0.8 (-1.27 to -0.31)
    -0.3 (-0.79 to 0.17)
    -0.9 (-1.59 to -0.20)
    -0.5 (-0.96 to -0.03)
        Change at Week 12 (n= 120, 119, 119, 114, 56, 121)
    -0.7 (-1.22 to -0.28)
    -0.9 (-1.40 to -0.46)
    -0.7 (-1.22 to -0.27)
    -0.3 (-0.77 to 0.19)
    -0.9 (-1.55 to -0.17)
    -0.4 (-0.84 to 0.09)
        Change at Week 24 (n= 119, 118, 120, 115, 56, 124)
    -0.8 (-1.26 to -0.25)
    -0.7 (-1.19 to -0.18)
    -0.8 (-1.28 to -0.27)
    -0.3 (-0.76 to 0.26)
    -1.0 (-1.69 to -0.21)
    -0.6 (-1.06 to -0.07)
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48

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    End point title
    Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
    End point description
    HADS: validated 14-item PRO measure assess states of anxiety and depression over past week. Items rated on 4-point severity scale. HADS produces 2 scales, 1 each for anxiety(HADS–A) and depression(HADS–D), differentiating two states with established normal score cut-offs. Instrument have been validated for use by adolescents >=12 years. Each subscale comprised of 7 items and subject responds how each item applies to him/her over past week prior to baseline visit, on 4-point response scale. Separate scores calculated for anxiety and depression with score ranges from 0 (no presence of anxiety/depression) to 3 (severe feeling of anxiety/depression). Total score range was from 0-21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1), Week 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 130, 130, 130, 131, 63, 65, 66)
    4.6 ( 3.84 )
    4.5 ( 3.18 )
    4.9 ( 3.31 )
    4.3 ( 3.42 )
    5.2 ( 3.38 )
    5.3 ( 4.20 )
    5.3 ( 3.70 )
        Change at Week 48(n=117,118,117,111,55,59,60)
    -1.0 ( 2.92 )
    -0.8 ( 3.10 )
    -0.8 ( 3.09 )
    -0.5 ( 3.40 )
    -1.2 ( 2.89 )
    -1.3 ( 3.31 )
    -0.5 ( 4.53 )
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48

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    End point title
    Percentage of Subjects With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48
    End point description
    HADS: validated 14-item PRO measure assess states of anxiety and depression over past week. Items rated on 4-point severity scale. HADS produces 2 scales, 1 each for anxiety(HADS–A) and depression(HADS–D), differentiating two states with established normal score cut-offs. Instrument have been validated for use by adolescents >=12 years. Each subscale comprised of 7 items and subject responds how each item applies to him/her over past week prior to baseline visit, on 4point response scale. Separate scores calculated for anxiety and depression with score ranges from 0 (no presence of anxiety/depression) to 3 (severe feeling of anxiety/depression). Total score range was from 0-21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Other pre-specified
    End point timeframe
    Week 4, 8, 12, 24 and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (n= 7, 10, 13, 14, 5, 5, 10)
    42.86 (6.20 to 79.52)
    60.00 (29.64 to 90.36)
    53.85 (26.75 to 80.95)
    42.86 (16.93 to 68.78)
    40.00 (0.00 to 82.94)
    60.00 (17.06 to 100.00)
    50.00 (19.01 to 80.99)
        Week 8 (n= 6, 11, 12, 12, 5, 4, 10)
    66.67 (28.95 to 100.00)
    45.45 (16.03 to 74.88)
    58.33 (30.44 to 86.23)
    33.33 (6.66 to 60.01)
    20.00 (0.00 to 55.06)
    50.00 (1.00 to 99.00)
    40.00 (9.64 to 70.36)
        Week 12 (n= 6, 11, 12, 13, 5, 5, 8)
    50.00 (9.99 to 90.01)
    63.64 (35.21 to 92.06)
    66.67 (39.99 to 93.34)
    30.77 (5.68 to 55.86)
    20.00 (0.00 to 55.06)
    60.00 (17.06 to 100.00)
    62.50 (28.95 to 96.05)
        Week 24 (n= 7, 11, 12, 14, 4, 4, 10)
    71.43 (37.96 to 100.00)
    63.64 (35.21 to 92.06)
    41.67 (13.77 to 69.56)
    42.86 (16.93 to 68.78)
    50.00 (1.00 to 99.00)
    50.00 (1.00 to 99.00)
    50.00 (19.01 to 80.99)
        Week 48 (n= 6, 11, 12, 13, 5, 5, 10)
    50.00 (9.99 to 90.01)
    63.64 (35.21 to 92.06)
    58.33 (30.44 to 86.23)
    46.15 (19.05 to 73.25)
    80.00 (44.94 to 100.00)
    60.00 (17.06 to 100.00)
    60.00 (29.64 to 90.36)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48

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    End point title
    Percentage of Subjects With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48
    End point description
    HADS: validated 14-item PRO measure assess states of anxiety and depression over past week. Items rated on 4-point severity scale. HADS produces 2 scales, 1 each for anxiety(HADS–A) and depression(HADS–D), differentiating two states with established normal score cut-offs. Instrument have been validated for use by adolescents >=12 years. Each subscale comprised of 7 items and subject responds how each item applies to him/her over past week prior to baseline visit, on 4-point response scale. Separate scores calculated for anxiety and depression with score ranges from 0 (no presence of anxiety/depression) to 3 (severe feeling of anxiety/depression). Total score range was from 0-21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1. FAS included all subjects who were randomised, regardless of whether they received study medication. Here, “n” signifies subjects evaluable at specific time point.
    End point type
    Other pre-specified
    End point timeframe
    Week 4, 8, 12, 24 and 48
    End point values
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Number of subjects analysed
    132
    130
    130
    132
    63
    65
    66
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4 (29, 22, 26, 16, 15, 19, 13)
    51.72 (33.54 to 69.91)
    45.45 (24.65 to 66.26)
    34.62 (16.33 to 52.90)
    37.50 (13.78 to 61.22)
    40.00 (15.21 to 64.79)
    31.58 (10.68 to 52.48)
    30.77 (5.68 to 55.86)
        Week 8 (n= 28, 20, 25, 12, 14, 18,13)
    46.43 (27.96 to 64.90)
    50.00 (28.09 to 71.91)
    68.00 (49.71 to 86.29)
    41.67 (13.77 to 69.56)
    71.43 (47.76 to 95.09)
    33.33 (11.56 to 55.11)
    46.15 (19.05 to 73.25)
        Week 12 (n= 28, 19, 26, 16, 14, 19, 12)
    50.00 (31.48 to 68.52)
    57.89 (35.69 to 80.10)
    38.46 (19.76 to 57.16)
    56.25 (31.94 to 80.56)
    42.86 (16.93 to 68.78)
    47.37 (24.92 to 69.82)
    41.67 (13.77 to 69.56)
        Week 24 (n= 27, 20, 26, 15, 14, 18, 13)
    51.85 (33.01 to 70.70)
    65.00 (44.10 to 85.90)
    50.00 (30.78 to 69.22)
    46.67 (21.42 to 71.91)
    57.14 (31.22 to 83.07)
    44.44 (21.49 to 67.40)
    38.46 (12.02 to 64.91)
        Week 48 (n= 26, 18, 25, 14, 13, 19, 12)
    53.85 (34.68 to 73.01)
    66.67 (44.89 to 88.44)
    60.00 (40.80 to 79.20)
    50.00 (23.81 to 76.19)
    61.54 (35.09 to 87.98)
    57.89 (35.69 to 80.10)
    58.33 (30.44 to 86.23)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53)
    Adverse event reporting additional description
    Same event may appear as both an adverse event(AE) and serious adverse event(SAE). An event may be categorised 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. Safety analysis set: all subjects who received at least 1 dose of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 200 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug .

    Reporting group title
    Ritlecitinib (PF-06651600) 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 200 mg then 30 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 200 mg tablet once daily for 4 weeks (loading phase) and then 30 mg tablet once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and continued to receive 30 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 30 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 30 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 30 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Ritlecitinib (PF-06651600) 10 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Subjects then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and received 200 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Reporting group title
    Placebo, Ritlecitinib (PF-06651600) 50 mg
    Reporting group description
    Subjects aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomised to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Subjects then entered into extension phase of 24 weeks and receive 50 mg tablet once daily. Subjects were followed up to maximum of 5 weeks after the last dose of study drug.

    Serious adverse events
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 131 (3.05%)
    2 / 130 (1.54%)
    2 / 129 (1.55%)
    1 / 132 (0.76%)
    2 / 62 (3.23%)
    0 / 65 (0.00%)
    3 / 66 (4.55%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Injury, poisoning and procedural complications
    Chemical poisoning
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 130 (0.00%)
    1 / 129 (0.78%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 130 (0.77%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    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
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    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
    Psychiatric disorders
    Conversion disorder
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 130 (0.00%)
    1 / 129 (0.78%)
    0 / 132 (0.00%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
    1 / 129 (0.78%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    1 / 132 (0.76%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Sepsis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 130 (0.00%)
    0 / 129 (0.00%)
    0 / 132 (0.00%)
    0 / 62 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Ritlecitinib (PF-06651600) 200 mg then 50 mg Ritlecitinib (PF-06651600) 50 mg Ritlecitinib (PF-06651600) 200 mg then 30 mg Ritlecitinib (PF-06651600) 30 mg Ritlecitinib (PF-06651600) 10 mg Placebo, Ritlecitinib (PF-06651600) 200 mg then 50 mg Placebo, Ritlecitinib (PF-06651600) 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 131 (64.12%)
    81 / 130 (62.31%)
    76 / 129 (58.91%)
    77 / 132 (58.33%)
    32 / 62 (51.61%)
    39 / 65 (60.00%)
    39 / 66 (59.09%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    9 / 131 (6.87%)
    4 / 130 (3.08%)
    8 / 129 (6.20%)
    8 / 132 (6.06%)
    1 / 62 (1.61%)
    0 / 65 (0.00%)
    2 / 66 (3.03%)
         occurrences all number
    10
    4
    8
    9
    2
    0
    3
    Headache
         subjects affected / exposed
    17 / 131 (12.98%)
    16 / 130 (12.31%)
    14 / 129 (10.85%)
    24 / 132 (18.18%)
    12 / 62 (19.35%)
    8 / 65 (12.31%)
    8 / 66 (12.12%)
         occurrences all number
    25
    21
    18
    40
    17
    25
    13
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 131 (3.05%)
    6 / 130 (4.62%)
    6 / 129 (4.65%)
    6 / 132 (4.55%)
    4 / 62 (6.45%)
    3 / 65 (4.62%)
    2 / 66 (3.03%)
         occurrences all number
    4
    8
    6
    7
    4
    3
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 131 (0.76%)
    5 / 130 (3.85%)
    5 / 129 (3.88%)
    3 / 132 (2.27%)
    0 / 62 (0.00%)
    4 / 65 (6.15%)
    0 / 66 (0.00%)
         occurrences all number
    1
    6
    5
    3
    0
    4
    0
    Constipation
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 130 (0.77%)
    0 / 129 (0.00%)
    7 / 132 (5.30%)
    1 / 62 (1.61%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences all number
    1
    1
    0
    7
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    9 / 131 (6.87%)
    12 / 130 (9.23%)
    4 / 129 (3.10%)
    8 / 132 (6.06%)
    0 / 62 (0.00%)
    4 / 65 (6.15%)
    1 / 66 (1.52%)
         occurrences all number
    9
    13
    4
    8
    0
    5
    1
    Vomiting
         subjects affected / exposed
    6 / 131 (4.58%)
    2 / 130 (1.54%)
    7 / 129 (5.43%)
    5 / 132 (3.79%)
    1 / 62 (1.61%)
    2 / 65 (3.08%)
    3 / 66 (4.55%)
         occurrences all number
    7
    3
    8
    8
    1
    2
    3
    Nausea
         subjects affected / exposed
    11 / 131 (8.40%)
    3 / 130 (2.31%)
    3 / 129 (2.33%)
    12 / 132 (9.09%)
    3 / 62 (4.84%)
    8 / 65 (12.31%)
    1 / 66 (1.52%)
         occurrences all number
    14
    5
    3
    15
    6
    10
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 131 (0.76%)
    2 / 130 (1.54%)
    1 / 129 (0.78%)
    3 / 132 (2.27%)
    4 / 62 (6.45%)
    1 / 65 (1.54%)
    1 / 66 (1.52%)
         occurrences all number
    1
    2
    1
    3
    4
    2
    1
    Cough
         subjects affected / exposed
    6 / 131 (4.58%)
    3 / 130 (2.31%)
    0 / 129 (0.00%)
    3 / 132 (2.27%)
    0 / 62 (0.00%)
    4 / 65 (6.15%)
    2 / 66 (3.03%)
         occurrences all number
    6
    4
    0
    3
    0
    4
    2
    Oropharyngeal pain
         subjects affected / exposed
    4 / 131 (3.05%)
    6 / 130 (4.62%)
    6 / 129 (4.65%)
    1 / 132 (0.76%)
    0 / 62 (0.00%)
    2 / 65 (3.08%)
    5 / 66 (7.58%)
         occurrences all number
    6
    6
    6
    1
    0
    3
    9
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 131 (3.05%)
    1 / 130 (0.77%)
    7 / 129 (5.43%)
    3 / 132 (2.27%)
    1 / 62 (1.61%)
    1 / 65 (1.54%)
    1 / 66 (1.52%)
         occurrences all number
    4
    1
    16
    3
    1
    1
    1
    Acne
         subjects affected / exposed
    6 / 131 (4.58%)
    12 / 130 (9.23%)
    10 / 129 (7.75%)
    12 / 132 (9.09%)
    3 / 62 (4.84%)
    5 / 65 (7.69%)
    8 / 66 (12.12%)
         occurrences all number
    9
    13
    13
    12
    4
    5
    9
    Rash
         subjects affected / exposed
    5 / 131 (3.82%)
    7 / 130 (5.38%)
    3 / 129 (2.33%)
    1 / 132 (0.76%)
    0 / 62 (0.00%)
    1 / 65 (1.54%)
    1 / 66 (1.52%)
         occurrences all number
    7
    7
    3
    2
    0
    1
    1
    Urticaria
         subjects affected / exposed
    9 / 131 (6.87%)
    7 / 130 (5.38%)
    9 / 129 (6.98%)
    5 / 132 (3.79%)
    1 / 62 (1.61%)
    4 / 65 (6.15%)
    4 / 66 (6.06%)
         occurrences all number
    12
    13
    11
    5
    1
    12
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 131 (2.29%)
    2 / 130 (1.54%)
    0 / 129 (0.00%)
    1 / 132 (0.76%)
    1 / 62 (1.61%)
    1 / 65 (1.54%)
    4 / 66 (6.06%)
         occurrences all number
    3
    2
    0
    1
    1
    1
    4
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    6 / 131 (4.58%)
    3 / 130 (2.31%)
    3 / 129 (2.33%)
    5 / 132 (3.79%)
    6 / 62 (9.68%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    6
    4
    3
    7
    8
    0
    1
    Arthralgia
         subjects affected / exposed
    4 / 131 (3.05%)
    2 / 130 (1.54%)
    5 / 129 (3.88%)
    4 / 132 (3.03%)
    2 / 62 (3.23%)
    2 / 65 (3.08%)
    6 / 66 (9.09%)
         occurrences all number
    4
    2
    5
    4
    2
    3
    6
    Infections and infestations
    Influenza
         subjects affected / exposed
    8 / 131 (6.11%)
    3 / 130 (2.31%)
    1 / 129 (0.78%)
    3 / 132 (2.27%)
    3 / 62 (4.84%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences all number
    8
    3
    1
    3
    3
    1
    0
    Folliculitis
         subjects affected / exposed
    11 / 131 (8.40%)
    8 / 130 (6.15%)
    11 / 129 (8.53%)
    5 / 132 (3.79%)
    4 / 62 (6.45%)
    4 / 65 (6.15%)
    4 / 66 (6.06%)
         occurrences all number
    13
    8
    13
    5
    4
    4
    5
    Nasopharyngitis
         subjects affected / exposed
    19 / 131 (14.50%)
    18 / 130 (13.85%)
    21 / 129 (16.28%)
    21 / 132 (15.91%)
    7 / 62 (11.29%)
    7 / 65 (10.77%)
    4 / 66 (6.06%)
         occurrences all number
    22
    21
    27
    29
    13
    8
    4
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 131 (13.74%)
    11 / 130 (8.46%)
    12 / 129 (9.30%)
    16 / 132 (12.12%)
    2 / 62 (3.23%)
    7 / 65 (10.77%)
    6 / 66 (9.09%)
         occurrences all number
    21
    14
    16
    20
    2
    8
    7
    Urinary tract infection
         subjects affected / exposed
    11 / 131 (8.40%)
    1 / 130 (0.77%)
    3 / 129 (2.33%)
    5 / 132 (3.79%)
    0 / 62 (0.00%)
    4 / 65 (6.15%)
    2 / 66 (3.03%)
         occurrences all number
    21
    1
    5
    6
    0
    4
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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

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