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    Clinical Trial Results:
    A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Abrocitinib 100 mg and 200 mg Tablets in Participants Aged 12 Years and Older with Moderate to Severe Atopic Dermatitis in India

    Summary
    EudraCT number
    		 2024-000141-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2024
    First version publication date
    30 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B7451094
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05375929
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235E42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Jul 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main study: To evaluate the safety of abrocitinib in participants aged 12 years and older with moderate to severe atopic dermatitis (AD). Substudy: To evaluate the potential effects of abrocitinib on bone development in adolescent participants 12 to less than (<) 18 years of age, as assessed by knee magnetic resonance imaging (MRI).
    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 trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    0
    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)
    33
    Adults (18-64 years)
    156
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 200 participants aged greater than or equal to (>=) 12 years with moderate to severe atopic dermatitis (AD) were enrolled in the study. As per statistical analysis plan (SAP) participants’ disposition, and discontinuation were to be summarized by treatment arm.

    Pre-assignment
    Screening details
    		 Study had main study and substudy. Adolescent participants consented for substudy at main study inform consent/assent to receive study intervention assigned in the main study after the 12-week treatment period, until 1 year after randomization in the main study or until they turned 18.

    Period 1
    Period 1 title
    Overall Study: Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Main Study: Abrocitinib 200 mg QD
    Arm description
    		 Participants received abrocitinib 200 milligram (mg), orally once daily (QD) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abrocitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received abrocitinib 200 mg, orally QD for 12 weeks.

    Arm title
    		 Main Study: Abrocitinib 100 mg QD
    Arm description
    		 Participants received abrocitinib 100 mg, orally QD for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abrocitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received abrocitinib 100 mg, orally QD for 12 weeks.

    Arm title
    		 Substudy: Abrocitinib 200 mg
    Arm description
    		 Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abrocitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received abrocitinib 200 mg, orally QD for 1 year after randomization.

    Arm title
    		 Substudy: Abrocitinib 100 mg
    Arm description
    		 Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abrocitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received abrocitinib 100 mg, orally QD for 1 year after randomization.

    Number of subjects in period 1
    		Main Study: Abrocitinib 200 mg QD Main Study: Abrocitinib 100 mg QD Substudy: Abrocitinib 200 mg Substudy: Abrocitinib 100 mg
    Started
    99
    101
    19
    16
    Completed
    91
    94
    12
    15
    Not completed
    8
    7
    7
    1
         Consent withdrawn by subject
    6
    5
    -
    -
         Physician decision
    -
    -
    4
    -
         Adverse event, non-fatal
    1
    -
    2
    -
         Lost to follow-up
    1
    1
    1
    -
         Withdrawal by parent/guardian
    -
    1
    -
    1
    Period 2
    Period 2 title
    Overall Study: Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Main Study: Abrocitinib 200 mg QD
    Arm description
    		 Participants received abrocitinib 200 mg, orally QD for 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Main Study: Abrocitinib 100 mg QD
    Arm description
    		 Participants received abrocitinib 100 mg, orally QD for 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Substudy: Abrocitinib 200 mg
    Arm description
    		 Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Substudy: Abrocitinib 100 mg
    Arm description
    		 Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Main Study: Abrocitinib 200 mg QD Main Study: Abrocitinib 100 mg QD Substudy: Abrocitinib 200 mg Substudy: Abrocitinib 100 mg
    Started
    91
    94
    12
    15
    Completed
    90
    93
    17
    15
    Not completed
    1
    1
    0
    0
         Did not complete study follow-up
    -
    1
    -
    -
         Lost to follow-up
    1
    -
    -
    -
    Joined
    0
    0
    5
    0
         Follow-up
    -
    -
    5
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Study: Abrocitinib 200 mg QD
    Reporting group description
    		 Participants received abrocitinib 200 milligram (mg), orally once daily (QD) for 12 weeks.

    Reporting group title
    Main Study: Abrocitinib 100 mg QD
    Reporting group description
    		 Participants received abrocitinib 100 mg, orally QD for 12 weeks.

    Reporting group title
    Substudy: Abrocitinib 200 mg
    Reporting group description
    		 Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.

    Reporting group title
    Substudy: Abrocitinib 100 mg
    Reporting group description
    		 Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.

    Reporting group values
    		 Main Study: Abrocitinib 200 mg QD Main Study: Abrocitinib 100 mg QD Substudy: Abrocitinib 200 mg Substudy: Abrocitinib 100 mg Total
    Number of subjects
    		 99 101 19 16 200
    Age categorical
    Units: Participants
        Adolescents (12-17 years)
    		 17 16 17 16 33
        Adults (18-64 years)
    		 78 78 2 0 156
        From 65-84 years
    		 4 7 0 0 11
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 35.37 ( 17.19 ) 37.50 ( 17.49 ) 14.79 ( 2.25 ) 14.44 ( 1.36 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 61 48 12 7 109
        Male
    		 38 53 7 9 91
    Race
    Units: Subjects
        Asian
    		 99 101 19 16 200
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 99 101 19 16 200

    End points

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    End points reporting groups
    Reporting group title
    Main Study: Abrocitinib 200 mg QD
    Reporting group description
    		 Participants received abrocitinib 200 milligram (mg), orally once daily (QD) for 12 weeks.

    Reporting group title
    Main Study: Abrocitinib 100 mg QD
    Reporting group description
    		 Participants received abrocitinib 100 mg, orally QD for 12 weeks.

    Reporting group title
    Substudy: Abrocitinib 200 mg
    Reporting group description
    		 Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.

    Reporting group title
    Substudy: Abrocitinib 100 mg
    Reporting group description
    		 Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.
    Reporting group title
    Main Study: Abrocitinib 200 mg QD
    Reporting group description
    		 Participants received abrocitinib 200 mg, orally QD for 12 weeks.

    Reporting group title
    Main Study: Abrocitinib 100 mg QD
    Reporting group description
    		 Participants received abrocitinib 100 mg, orally QD for 12 weeks.

    Reporting group title
    Substudy: Abrocitinib 200 mg
    Reporting group description
    		 Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.

    Reporting group title
    Substudy: Abrocitinib 100 mg
    Reporting group description
    		 Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.

    Subject analysis set title
    Main Study: Abrocitinib 200 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants included in this analysis set are those who actually received abrocitinib 200 mg, orally QD for 12 weeks.

    Subject analysis set title
    Main Study: Abrocitinib 100 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants included in this analysis set are those who actually received abrocitinib 100 mg, orally QD for 12 weeks.

    Subject analysis set title
    Main Study: Abrocitinib 200 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants included in this analysis set are according to their randomization in abrocitinib 200 mg group.

    Subject analysis set title
    Main Study: Abrocitinib 100 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants included in this analysis set are according to their randomization in abrocitinib 100 mg group.

    Primary: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Main Study

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    End point title
    		 Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs): Main Study [1]
    End point description
    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other situations where medical or scientific judgement should be exercised by investigator. AEs included SAEs and all non-SAEs. Safety analysis set included all participants randomly assigned to study intervention and who had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    From Day 1 of dosing up to 4 weeks post last dose (maximum up to Week 16)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned for this endpoint.
    End point values
    		 Main Study: Abrocitinib 200 mg Main Study: Abrocitinib 100 mg
    Number of subjects analysed
    99
    101
    Units: Count of Participants
        AEs
    30
    26
        SAEs
    0
    1
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and >= 2 Points Improvement From Baseline at Week 12: Main Study

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    End point title
    		 Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and >= 2 Points Improvement From Baseline at Week 12: Main Study
    End point description
    IGA assesses severity of AD on 5-point scale. Scores: 0= clear (no AD inflammatory signs except for any residual discolouration [post-inflammatory hyperpigmentation and/or hypopigmentation]); 1= almost clear (AD not entirely cleared- light pink residual lesions [except post-inflammatory hyperpigmentation], just barely perceptible erythema, papulation/induration lichenification, excoriation and no oozing/crusting); 2= mild (AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting); 3= moderate (AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting); 4= severe (AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting). Full analysis set analyzed. Non-responder imputation (NRI) applied. Number of Participants Analyzed = participants evaluable.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to dosing on Day 1), Week 12
    End point values
    		 Main Study: Abrocitinib 200 mg Main Study: Abrocitinib 100 mg
    Number of subjects analysed
    99
    100
    Units: Percentage of participants
        number (confidence interval 95%)
    48.5 (38.6 to 58.3)
    50.0 (40.2 to 59.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >= 75% Improvement From Baseline at Week 12: Main Study

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    End point title
    		 Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >= 75% Improvement From Baseline at Week 12: Main Study
    End point description
    EASI evaluated severity of participant's AD based on both severity of lesion clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t]-[including axillae and groin] and lower limbs [l]-[including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et + It + Ext + Lt) + 0.4*Al*(El + Il + Exl +Ll); A = EASI area score. EASI score range: 0.0 to 72.0, higher scores = greater severity. Full analysis analyzed. NRI applied. Number of Participants Analyzed = participants evaluable.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to dosing on Day 1), Week 12
    End point values
    		 Main Study: Abrocitinib 200 mg Main Study: Abrocitinib 100 mg
    Number of subjects analysed
    99
    100
    Units: Percentage of participants
        number (confidence interval 95%)
    71.7 (62.8 to 80.6)
    69.0 (59.9 to 78.1)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8 and 12: Main Study

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    End point title
    		 Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8 and 12: Main Study
    End point description
    POEM is a 7-item participant reported outcome (PRO) measure to assess the impact of AD over the past week. Items were: dryness or roughness of skin in day, skin being itchy in day, skin flaking off in day, skin cracking in day, skin bleeding in day, skin weeping or oozing in day and sleep disturbed in night. Each item is scored from 0 to 4, depending on number of days/night (for sleep items) over the past week symptoms happened, where 0= no days, 1= “1-2 days”, 2= "3-4 days”, 3= "5-6 days" and 4= "every day". Scores from all items are added up, which results in POEM score, ranging from 0 to 28, higher scores = greater severity and greater symptom burden. FAS evaluated. Participants were analyzed according to the treatment arm they were randomized to. All participants reported under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to dosing on Day 1), Weeks 2, 4, 8 and 12
    End point values
    		 Main Study: Abrocitinib 200 mg Main Study: Abrocitinib 100 mg
    Number of subjects analysed
    100
    100
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 2 (97, 98)
    -6.3 ( 4.97 )
    -5.1 ( 5.12 )
        Week 4 (96, 96)
    -9.4 ( 5.42 )
    -8.1 ( 5.49 )
        Week 8 (94, 96)
    -12.0 ( 5.98 )
    -10.3 ( 5.55 )
        Week 12 (92, 93)
    -14.2 ( 5.88 )
    -12.4 ( 6.02 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >= 75% Improvement From Baseline at Week 12: Main Study

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    End point title
    		 Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >= 75% Improvement From Baseline at Week 12: Main Study
    End point description
    SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. Score for each body region was added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; lichenification; dryness) assessed as none =0, mild =1, moderate =2, severe =3. Severity scores were added to give B (0-18). C: pruritus and sleep, each was scored by participant/caregiver using visual analogue scale (VAS) where 0= no itch/no sleeplessness and 10= worst imaginable itch/sleeplessness. Scores for itch and sleeplessness were added to give C (0-20). Total SCORAD was calculated: A/5 + 7*B/2 + C; SCORAD range from 0-103; higher SCORAD scores = greater severity. Full analysis analyzed. NRI applied. Number of Participants Analyzed = participants evaluable.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to dosing on Day 1), Week 12
    End point values
    		 Main Study: Abrocitinib 200 mg Main Study: Abrocitinib 100 mg
    Number of subjects analysed
    99
    100
    Units: Percentage of participants
        number (confidence interval 95%)
    47.5 (37.6 to 57.3)
    43.0 (33.3 to 52.7)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Score at Weeks 2, 4, 8 and 12: Main Study

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    End point title
    		 Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Score at Weeks 2, 4, 8 and 12: Main Study
    End point description
    ADCT score is used to measure the participants perceived AD control. It consists of 6 questions (overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions) which are evaluated over the past week on scale from 0 to 4. Scores from all 6 questions are added up to provide ADCT score, ranging from 0 to 24, where higher scores indicate lower AD control. FAS included all participants randomly assigned to study intervention and had taken at least 1 dose of study intervention. Participants were analyzed according to the treatment arm they were randomized to. All participants reported under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to dosing on Day 1), Weeks 2, 4, 8 and 12
    End point values
    		 Main Study: Abrocitinib 200 mg Main Study: Abrocitinib 100 mg
    Number of subjects analysed
    100
    100
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 2 (97, 98)
    -5.2 ( 4.06 )
    -4.4 ( 4.57 )
        Week 4 (96, 96)
    -8.1 ( 4.90 )
    -7.4 ( 4.64 )
        Week 8 (94, 96)
    -10.7 ( 4.80 )
    -9.4 ( 5.21 )
        Week 12 (91, 93)
    -12.8 ( 5.33 )
    -11.5 ( 5.64 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Bone Safety Findings in Knee Magnetic Resonance Imaging (MRI) at 1 Year After Randomization: Substudy

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    End point title
    		 Percentage of Participants With Bone Safety Findings in Knee Magnetic Resonance Imaging (MRI) at 1 Year After Randomization: Substudy [2]
    End point description
    MRI imaging session was performed when participant was in supine position in the confined space of the MRI scanner for approximately 30 mins. The assessments included evaluation of epiphyseal plate closure and mineralization of cartilage at the growth centres. Substudy analysis set included all participants who entered the substudy and who took at least 1 dose of study intervention during the substudy.
    End point type
    Secondary
    End point timeframe
    Up to 1 year from randomization on Day 1 of main study
    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: This endpoint was planned to be analysed only for the specified reporting arms.
    End point values
    		 Substudy: Abrocitinib 200 mg Substudy: Abrocitinib 100 mg
    Number of subjects analysed
    19
    16
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 17.6)
    0 (0.0 to 20.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Main Study: From Day 1 of dosing up to 4 weeks post last dose (last dose at Week 12, maximum follow-up till Week 16); Sub Study: From Day 1 of dosing (in main study) up to 4 weeks post last dose (last dose at Year 1, maximum follow-up till Year 1.08)
    Adverse event reporting additional description
    Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. MedDRA used: for main study v 26.0; for substudy v 27.0. Safety analysis set used for main study; substudy analysis set used for substudy.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0, 27.0
    Reporting groups
    Reporting group title
    Abrocitinib 200 mg QD
    Reporting group description
    		 Enter Description here

    Reporting group title
    Substudy: Abrocitinib 200 mg
    Reporting group description
    		 Eligible adolescent participants who received abrocitinib 200 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.

    Reporting group title
    Substudy: Abrocitinib 100 mg
    Reporting group description
    		 Eligible adolescent participants who received abrocitinib 100 mg orally QD for 12 weeks in main study, continued to receive the same treatment in similar way until 1 year after randomization (on Day 1) from main study.

    Reporting group title
    Abrocitinib 100 mg QD
    Reporting group description
    		 Enter Description here

    Serious adverse events
    		 Abrocitinib 200 mg QD Substudy: Abrocitinib 200 mg Substudy: Abrocitinib 100 mg Abrocitinib 100 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 101 (0.99%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Abrocitinib 200 mg QD Substudy: Abrocitinib 200 mg Substudy: Abrocitinib 100 mg Abrocitinib 100 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 99 (22.22%)
    8 / 19 (42.11%)
    5 / 16 (31.25%)
    20 / 101 (19.80%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    3 / 101 (2.97%)
         occurrences all number
    1
    0
    0
    3
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
    3 / 101 (2.97%)
         occurrences all number
    1
    1
    4
    3
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 99 (3.03%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nausea
         subjects affected / exposed
    9 / 99 (9.09%)
    2 / 19 (10.53%)
    0 / 16 (0.00%)
    5 / 101 (4.95%)
         occurrences all number
    9
    2
    0
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 99 (4.04%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    2 / 101 (1.98%)
         occurrences all number
    6
    0
    0
    2
    Gastritis
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
    3 / 101 (2.97%)
         occurrences all number
    1
    1
    1
    3
    Asthma
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 99 (1.01%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
    4 / 101 (3.96%)
         occurrences all number
    1
    1
    2
    4
    Rosacea
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    4 / 99 (4.04%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
    2 / 101 (1.98%)
         occurrences all number
    4
    0
    0
    3
    Infections and infestations
    Eczema herpeticum
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Joint tuberculosis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 99 (0.00%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
    0 / 101 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyoderma
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Varicella
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2022
    Added SCORAD efficacy assessment for atopic dermatitis as a secondary endpoint. Added laboratory tests at end of treatment (EoT) visit of the substudy. Updated substudy schedule of assessments (SoA) and relevant sections.

    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.
    One participant was randomized to abrocitinib 200 mg arm but received abrocitinib 100 mg, hence for safety analysis set of main study that participant was included in 100 mg arm and for full analysis set that participant was included in 200 mg arm.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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