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    Clinical Trial Results:
    A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants with Alopecia Areata

    Summary
    EudraCT number
    		 2020-000113-33
    Trial protocol
    		 FR  
    Global end of trial date
    16 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2025
    First version publication date
    30 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM011-134
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Global Submission Management, Clinical Trials, Bristol-Myers Squibb International Corporation, mg-gsm-ct@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, mg-gsm-ct@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Change from baseline in SALT score at Week 24
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Nov 2022
    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
    Canada: 35
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Japan: 12
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    United States: 19
    Country: Number of subjects enrolled
    Australia: 4
    Worldwide total number of subjects
    94
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    93
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was terminated due to change in business objectives.

    Pre-assignment
    Screening details
    		 94 participants randomized and treated in Placebo controlled period. the 31 participants in the placebo cohort, were re-randomized into the active treatment period (ATP) cohort.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Deucravacitinib 6 mg QD
    Arm description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg QD

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Arm title
    		 Deucravacitinib 6 mg BID
    Arm description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg BID

    Arm title
    		 Placebo
    Arm description
    		 Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Number of subjects in period 1
    		Deucravacitinib 6 mg QD Deucravacitinib 6 mg BID Placebo
    Started
    32
    31
    31
    Completed
    32
    26
    31
    Not completed
    0
    5
    0
         Consent withdrawn by subject
    -
    1
    -
         Adverse event, non-fatal
    -
    2
    -
         Participant request to discontinue study treatment
    -
    2
    -
    Period 2
    Period 2 title
    Active Treatment (Week 25 to Week 52)
    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
    		 Deucravacitinib 6 mg QD
    Arm description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6mg QD

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6mg BID

    Arm title
    		 Deucravacitinib 6 mg BID
    Arm description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Arm title
    		 Placebo followed by Deucravacitinib 6 mg QD
    Arm description
    		 Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6mg QD

    Arm title
    		 Placebo followed by Deucravacitinib 6 mg BID
    Arm description
    		 Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deucravacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6mg BID

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo

    Number of subjects in period 2
    		Deucravacitinib 6 mg QD Deucravacitinib 6 mg BID Placebo followed by Deucravacitinib 6 mg QD Placebo followed by Deucravacitinib 6 mg BID
    Started
    32
    26
    16
    15
    Completed
    8
    5
    5
    3
    Not completed
    24
    21
    11
    12
         Consent withdrawn by subject
    2
    2
    3
    1
         Adverse event, non-fatal
    1
    1
    1
    -
         Study terminated by sponsor
    19
    12
    6
    9
         Lost to follow-up
    -
    2
    -
    1
         Lack of efficacy
    1
    1
    1
    -
         Participant request to discontinue study treatment
    1
    3
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Deucravacitinib 6 mg QD
    Reporting group description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    Deucravacitinib 6 mg BID
    Reporting group description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group values
    		 Deucravacitinib 6 mg QD Deucravacitinib 6 mg BID Placebo Total
    Number of subjects
    		 32 31 31 94
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 32 30 31 93
        From 65-84 years
    		 0 1 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.1 ( 13.37 ) 43.4 ( 13.81 ) 38.9 ( 14.40 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 22 22 20 64
        Male
    		 10 9 11 30
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 8 6 10 24
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 1 4 2 7
        White
    		 22 20 19 61
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 1 1 0 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 3 0 4
        Not Hispanic or Latino
    		 31 28 31 90
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Deucravacitinib 6 mg QD
    Reporting group description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    Deucravacitinib 6 mg BID
    Reporting group description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
    Reporting group title
    Deucravacitinib 6 mg QD
    Reporting group description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    Deucravacitinib 6 mg BID
    Reporting group description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    Placebo followed by Deucravacitinib 6 mg QD
    Reporting group description
    		 Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.

    Reporting group title
    Placebo followed by Deucravacitinib 6 mg BID
    Reporting group description
    		 Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.

    Subject analysis set title
    Placebo-Controlled: Deucravacitinib 6 mg QD
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.

    Subject analysis set title
    Placebo-Controlled: Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Subject analysis set title
    Placebo-Controlled: Deucravacitinib 6 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period

    Subject analysis set title
    Active Treatment Period: Deucravacitinib 6 mg QD
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants initially randomized to deucravacitinib 6 mg QD in placebo-controlled period continued on their assigned dosage in Active Treatment Period till Week 52.

    Subject analysis set title
    Active Treatment Period: Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.

    Subject analysis set title
    PBO followed by Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.

    Subject analysis set title
    Active Treatment Period: Deucravacitinib 6 mg QD
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.

    Subject analysis set title
    PBO followed by Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.

    Subject analysis set title
    Placebo-Controlled: Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Subject analysis set title
    Active Treatment Period: Deucravacitinib 6 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.

    Subject analysis set title
    Active Treatment Period: Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.

    Subject analysis set title
    PBO followed by Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.

    Subject analysis set title
    Placebo-Controlled: Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Subject analysis set title
    PBO followed by Deucravacitinib 6 mg BID
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.

    Subject analysis set title
    ATP: PBO followed by Deucravacitinib 6 mg QD
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.

    Subject analysis set title
    ATP: PBO followed by Deucravacitinib 6 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.

    Primary: Change from Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period

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    End point title
    		 Change from Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period [1]
    End point description
    The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp: back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by it's respective weighting factor (percentage surface area of the scalp in that area; back region [24%], top region [40%], left region [18%] and, right region [18%]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 24
    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: no further statistical analysis done for this endpoint
    End point values
    		 Deucravacitinib 6 mg QD Deucravacitinib 6 mg BID Placebo
    Number of subjects analysed
    32
    31
    31
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    -5.809 ( 13.3892 )
    1.027 ( 14.7258 )
    -7.302 ( 17.8732 )
    No statistical analyses for this end point

    Primary: Number of Participants with Treatment Emergent Adverse Events in Placebo-Controlled Period

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events in Placebo-Controlled Period [2]
    End point description
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included herpes zoster, malignancy, opportunistic infection or tuberculosis infection. Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma = IMN-HL
    End point type
    Primary
    End point timeframe
    From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    End point values
    		 Deucravacitinib 6 mg QD Deucravacitinib 6 mg BID Placebo
    Number of subjects analysed
    32
    31
    31
    Units: Participants
        Treatment Emergent Adverse Events
    25
    28
    20
        Serious Treatment Emergent Adverse Events
    1
    1
    0
        TEAE Leading to Discontinuation of Study
    1
    3
    0
        TEAE of Interest-Herpes Zoster
    1
    0
    0
        TEAE of Interest-Malignancy-Bowen's Disease)
    0
    1
    0
        TEAE of IMN-HL
    0
    1
    0
        TEAE of Interest - Opportunistic Infections
    0
    0
    0
        TEAE of Interest - Tuberculosis Infection
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Treatment Emergent Adverse Events in Active Treatment Period

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events in Active Treatment Period [3]
    End point description
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included Herpes zoster, malignancy, opportunities infection or tuberculosis infection. Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma = IMN-HL
    End point type
    Primary
    End point timeframe
    From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    End point values
    		 Active Treatment Period: Deucravacitinib 6 mg QD Active Treatment Period: Deucravacitinib 6 mg BID PBO followed by Deucravacitinib 6 mg BID ATP: PBO followed by Deucravacitinib 6 mg QD
    Number of subjects analysed
    32
    26
    15
    16
    Units: Participants
        Treatment Emergent Adverse Events
    21
    17
    14
    13
        Serious Treatment Emergent Adverse Events
    0
    1
    0
    0
        TEAE Leading to Discontinuation of Study
    1
    0
    0
    1
        TEAE of Interest-Herpes Zoster
    0
    0
    0
    0
        TEAE of Interest-Malignancy-Bowen's Disease
    0
    0
    0
    0
        TEAE of IMN-HL
    0
    0
    0
    0
        TEAE of Interest - Opportunistic Infections
    0
    0
    0
    0
        TEAE of Interest - Tuberculosis Infection
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Worst Toxicity Grade Change from Baseline to Grade 3/Grade 4 in Laboratory Test Results as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period

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    End point title
    		 Number of Participants with Worst Toxicity Grade Change from Baseline to Grade 3/Grade 4 in Laboratory Test Results as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period [4]
    End point description
    Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
    End point type
    Primary
    End point timeframe
    From first dose (Day 1) through Week 24
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    End point values
    		 Deucravacitinib 6 mg QD Deucravacitinib 6 mg BID Placebo
    Number of subjects analysed
    32
    31
    31
    Units: participants
        HEMOGLOBIN, LOW
    0
    0
    0
        PLATELET COUNT, LOW
    0
    0
    0
        LEUKOCYTES, LOW
    0
    0
    0
        ALANINE AMINOTRANSFERASE (ALT), HIGH
    0
    0
    0
        ALKALINE PHOSPHATASE (ALP), HIGH
    0
    0
    0
        ASPARTATE AMINOTRANSFERASE (AST), HIGH
    0
    0
    0
        BILIRUBIN, TOTAL, HIGH
    0
    0
    0
        CREATININE, ENZYMATIC, HIGH
    0
    0
    0
        ALBUMIN, LOW
    0
    0
    0
        CALCIUM, LOW
    0
    0
    0
        CALCIUM, HIGH
    0
    0
    0
        CHOLESTEROL, TOTAL (TC), HIGH
    0
    0
    0
        CREATINE KINASE (CK), HIGH
    0
    1
    2
        GLUCOSE, LOW
    0
    0
    0
        POTASSIUM, LOW
    0
    0
    0
        POTASSIUM, HIGH
    1
    0
    0
        SODIUM, LOW
    0
    0
    0
        SODIUM, HIGH
    0
    0
    0
        TRIGLYCERIDES, HIGH
    0
    0
    0
        GLUCOSE FASTING, LOW
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Worst Toxicity Grade Change from Baseline to Grade 3/Grade 4 in Laboratory Test Results as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period

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    End point title
    		 Number of Participants with Worst Toxicity Grade Change from Baseline to Grade 3/Grade 4 in Laboratory Test Results as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period [5]
    End point description
    Blood samples were collected for assessment of laboratory test results. All abnormalities are graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
    End point type
    Primary
    End point timeframe
    From Week 25 to Week 52
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    End point values
    		 Active Treatment Period: Deucravacitinib 6 mg QD Active Treatment Period: Deucravacitinib 6 mg BID PBO followed by Deucravacitinib 6 mg BID ATP: PBO followed by Deucravacitinib 6 mg QD
    Number of subjects analysed
    32
    26
    15
    16
    Units: participants
        HEMOGLOBIN, LOW
    0
    0
    0
    0
        PLATELET COUNT, LOW
    0
    0
    0
    0
        LEUKOCYTES, LOW
    0
    0
    0
    0
        ALANINE AMINOTRANSFERASE (ALT), HIGH
    0
    0
    0
    0
        ALKALINE PHOSPHATASE (ALP), HIGH
    0
    0
    0
    0
        ASPARTATE AMINOTRANSFERASE (AST), HIGH
    0
    0
    0
    0
        BILIRUBIN, TOTAL, HIGH
    0
    0
    0
    0
        CREATININE, ENZYMATIC, HIGH
    0
    0
    0
    0
        ALBUMIN, LOW
    0
    0
    0
    0
        CALCIUM, LOW
    0
    0
    0
    0
        CALCIUM, HIGH
    0
    0
    0
    0
        CHOLESTEROL, TOTAL (TC), HIGH
    0
    0
    0
    0
        CREATINE KINASE (CK), HIGH
    0
    0
    0
    0
        GLUCOSE, LOW
    0
    0
    0
    0
        POTASSIUM, LOW
    0
    0
    0
    0
        POTASSIUM, HIGH
    0
    0
    0
    0
        SODIUM, LOW
    0
    0
    0
    0
        SODIUM, HIGH
    0
    0
    0
    0
        TRIGLYCERIDES, HIGH
    0
    0
    0
    0
        GLUCOSE FASTING, LOW
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Marked Electrocardiogram Abnormalities in Placebo-Controlled period

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    End point title
    		 Number of Participants with Marked Electrocardiogram Abnormalities in Placebo-Controlled period [6] [7]
    End point description
    A 12-lead ECG was performed after the participant remained supine for at least 5 minutes prior to the ECG. The ECG results read by the principal study investigator or a qualified and delegated designee as per local requirements
    End point type
    Primary
    End point timeframe
    First dose (Day 1) to Week 24
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    [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: placebo group from period 1 is represented in the 2 placebo to treatment groups.
    End point values
    		 Placebo Placebo-Controlled: Deucravacitinib 6 mg QD Placebo-Controlled: Deucravacitinib 6 mg BID
    Number of subjects analysed
    31
    32
    29
    Units: Participants
        QTCF 450 -< 480 MILLISECONDS (MSEC)
    1
    0
    2
        QTCF 480 -< 500 MSEC
    0
    0
    0
        QTCF >= 500 MSEC
    0
    0
    0
        QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC
    0
    0
    1
        QTCF CHANGE FROM BASELINE > 60 MSEC
    0
    0
    0
        PR INTERVAL >= 200 MSEC
    1
    2
    0
        QRS INTERVAL >= 120 MSEC
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Marked Electrocardiogram Abnormalities in Active Treatment Period

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    End point title
    		 Number of Participants with Marked Electrocardiogram Abnormalities in Active Treatment Period [8]
    End point description
    A 12-lead ECG should be performed after the participant has remained supine for at least 5 minutes prior to the ECG. The ECG results will be read by the principal study investigator or a qualified and delegated designee as per local requirements
    End point type
    Primary
    End point timeframe
    Week 25 to Week 52
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    End point values
    		 Active Treatment Period: Deucravacitinib 6 mg QD Active Treatment Period: Deucravacitinib 6 mg BID PBO followed by Deucravacitinib 6 mg BID ATP: PBO followed by Deucravacitinib 6 mg QD
    Number of subjects analysed
    28
    19
    14
    14
    Units: Participants
        QTCF 450 -< 480 MILLISECONDS (MSEC)
    0
    0
    0
    0
        QTCF 480 -< 500 MSEC
    0
    0
    0
    0
        QTCF >= 500 MSEC
    0
    0
    0
    0
        QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC
    1
    1
    1
    1
        QTCF CHANGE FROM BASELINE > 60 MSEC
    0
    0
    0
    0
        PR INTERVAL >= 200 MSEC
    1
    0
    1
    1
        QRS INTERVAL >= 120 MSEC
    1
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of Participants with Abnormalities in Marked Vital Signs in Placebo-Controlled period

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    End point title
    		 Number of Participants with Abnormalities in Marked Vital Signs in Placebo-Controlled period [9] [10]
    End point description
    Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant has been resting quietly for at least 5 minutes. Change from Baseline = CFB
    End point type
    Primary
    End point timeframe
    First dose (Day 1) to Week 24
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    [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: placebo group from period 1 is represented in the 2 placebo to treatment groups.
    End point values
    		 Placebo Placebo-Controlled: Deucravacitinib 6 mg QD Placebo-Controlled: Deucravacitinib 6 mg BID
    Number of subjects analysed
    31
    32
    30
    Units: Participants
        HEART RATE > 100 BPM AND CFB > 30 BPM
    0
    0
    1
        HEART RATE < 55 BPM AND CFB < -15 BPM
    0
    1
    0
        SBP >140 MM HG AND CFB > 20 MM HG
    1
    1
    4
        SBP <90 MM HG AND CFB < -20 MM HG
    1
    0
    0
        DBP >90 MM HG AND CFB > 10 MM HG
    1
    3
    0
        DBP <55 MM HG AND CFB < -10 MM HG
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Abnormalities in Marked Vital Signs in Active Treatment Period

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    End point title
    		 Number of Participants with Abnormalities in Marked Vital Signs in Active Treatment Period [11]
    End point description
    Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant had been resting quietly for at least 5 minutes. Change from Baseline = CFB
    End point type
    Primary
    End point timeframe
    Week 25 to Week 52
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    End point values
    		 Active Treatment Period: Deucravacitinib 6 mg QD Active Treatment Period: Deucravacitinib 6 mg BID PBO followed by Deucravacitinib 6 mg BID ATP: PBO followed by Deucravacitinib 6 mg QD
    Number of subjects analysed
    32
    26
    15
    16
    Units: Participants
        HEART RATE > 100 BPM AND CFB > 30 BPM
    0
    0
    1
    0
        HEART RATE < 55 BPM AND CFB < -15 BPM
    1
    1
    0
    0
        SBP >140 MM HG AND CFB > 20 MM HG
    1
    1
    1
    0
        SBP <90 MM HG AND CFB < -20 MM HG
    0
    0
    0
    0
        DBP >90 MM HG AND CFB > 10 MM HG
    0
    1
    3
    0
        DBP <55 MM HG AND CFB < -10 MM HG
    1
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of Participants with Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period

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    End point title
    		 Number of Participants with Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period [12] [13]
    End point description
    Participants were assessed for abnormalities in targeted physical parameters.
    End point type
    Primary
    End point timeframe
    First dose (Day 1) to Week 24
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    [13] - 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: placebo group from period 1 is represented in the 2 placebo to treatment groups.
    End point values
    		 Placebo Placebo-Controlled: Deucravacitinib 6 mg QD Placebo-Controlled: Deucravacitinib 6 mg BID
    Number of subjects analysed
    31
    32
    31
    Units: Participants
        Abdomen
    1
    0
    0
        Extremities
    1
    0
    1
        General Appearance
    0
    1
    1
        Genitourinary
    0
    1
    0
        Head, Eyes, Ears, Nose, Throat
    2
    3
    6
        Lymph Nodes
    0
    0
    0
        Mouth
    0
    3
    0
        Musculoskeletal
    0
    1
    1
        Neck
    0
    0
    0
        Neurological
    1
    2
    0
        Psychiatric
    1
    1
    0
        Respiratory
    1
    0
    1
        Skin
    6
    9
    14
        Other
    0
    1
    1
    No statistical analyses for this end point

    Primary: Number of Participants with Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters

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    End point title
    		 Number of Participants with Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters [14]
    End point description
    Participants were assessed for abnormalities in targeted physical parameters.
    End point type
    Primary
    End point timeframe
    Week 25 to Week 52
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: no further statistical analysis done for this endpoint
    End point values
    		 Active Treatment Period: Deucravacitinib 6 mg QD Active Treatment Period: Deucravacitinib 6 mg BID PBO followed by Deucravacitinib 6 mg BID ATP: PBO followed by Deucravacitinib 6 mg QD
    Number of subjects analysed
    32
    26
    15
    16
    Units: Participants
        Abdomen
    0
    3
    0
    0
        Extremities
    0
    1
    0
    0
        General Appearance
    0
    0
    0
    0
        Genitourinary
    1
    1
    0
    0
        Head, Eyes, Ears, Nose, Throat
    0
    5
    2
    2
        Lymph Nodes
    0
    1
    0
    0
        Mouth
    2
    1
    2
    1
        Musculoskeletal
    1
    2
    0
    1
        Neck
    0
    1
    0
    0
        Neurological
    0
    0
    0
    0
        Other
    2
    2
    4
    0
        Psychiatric
    0
    0
    1
    0
        Respiratory
    1
    3
    2
    0
        Skin
    8
    6
    8
    5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) score (SALT50 response) from Baseline at Week 24

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    End point title
    		 Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) score (SALT50 response) from Baseline at Week 24 [15]
    End point description
    The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp; back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by its respective weighting factor (percentage surface area of the scalp in that area; Back region [24%], Left Region [18%], Right Region [18%], Top Region [40%]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata. SALT50 response indicates at least a 50% improvement from baseline in the SALT score at a particular time point, indicating 50% hair regrowth.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    Notes
    [15] - 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: placebo group from period 1 is represented in the 2 placebo to treatment groups.
    End point values
    		 Placebo Placebo-Controlled: Deucravacitinib 6 mg QD Placebo-Controlled: Deucravacitinib 6 mg BID
    Number of subjects analysed
    31
    32
    31
    Units: Percentage of participants
        number (not applicable)
    6.5
    3.1
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) score ≤20 at Week 24

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    End point title
    		 Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) score ≤20 at Week 24 [16]
    End point description
    The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp; back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by its respective weighting factor (percentage surface area of the scalp in that area; Back region [24%], Left Region [18%], Right Region [18%], Top Region [40%]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata. percentage of participants achieving an absolute SALT score ≤ 20, indicates ≤ 20% scalp hair loss.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: no further statistical analysis done for this endpoint
    End point values
    		 Placebo Placebo-Controlled: Deucravacitinib 6 mg QD Placebo-Controlled: Deucravacitinib 6 mg BID
    Number of subjects analysed
    31
    32
    31
    Units: Percentage of participants
        number (not applicable)
    0
    3.1
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving an Alopecia Areata Investigator Global Assessment (AA-IGA) Score of 0 or 1 at Week 24 with at least a 2-Point Change from Baseline

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    End point title
    		 Percentage of Participants Achieving an Alopecia Areata Investigator Global Assessment (AA-IGA) Score of 0 or 1 at Week 24 with at least a 2-Point Change from Baseline [17]
    End point description
    The AA-IGA utilizes a 5-points scale, in which the investigator assesses scalp hair loss based on the SALT assessment. The AA-IGA measures alopecia areata severity at a single point in time(without taking into account the baseline disease condition).The participant’s scalp hair loss, as it look at the time of evaluation is scored as none (0) (0% scalp hair loss), limited (1) (1%-20% scalp hair loss), moderate (2) (21%-49% scalp hair loss), severe (3) (50%-94% scalp hair loss), or very severe (4)(95%-100 % scalp hair loss).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and week 24
    Notes
    [17] - 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: placebo group from period 1 is represented in the 2 placebo to treatment groups.
    End point values
    		 Placebo Placebo-Controlled: Deucravacitinib 6 mg QD Placebo-Controlled: Deucravacitinib 6 mg BID
    Number of subjects analysed
    31
    32
    31
    Units: Percentage of participants
        number (not applicable)
    0
    3.1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality: Week 0 to 52. Serious AEs were collected from ICF signing to 30 days post last dose (up to 32 weeks and 28 weeks) in both periods. Non-serious AEs were collected from Day 1 to 30 days post last dose (up to 28 weeks for both periods).
    Adverse event reporting additional description
    Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. ATP = Active Treatment Period PBO = Placebo
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    PBO-Controlled: Deucravacitinib 6mg QD
    Reporting group description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    PBO-Controlled: Deucravacitinib 6mgBID
    Reporting group description
    		 Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.

    Reporting group title
    ATP: PBO followed by Deucravacitinib 6 mg BID
    Reporting group description
    		 Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.

    Reporting group title
    ATP: Deucravacitinib 6 mg BID
    Reporting group description
    		 Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.

    Reporting group title
    ATP: PBO followed by Deucravacitinib 6 mg QD
    Reporting group description
    		 Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib QD tablet orally till Week 52 in Active Treatment Period.

    Reporting group title
    ATP: Deucravacitinib 6 mg QD
    Reporting group description
    		 Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.

    Serious adverse events
    		 PBO-Controlled: Deucravacitinib 6mg QD PBO-Controlled: Deucravacitinib 6mgBID Placebo ATP: PBO followed by Deucravacitinib 6 mg BID ATP: Deucravacitinib 6 mg BID ATP: PBO followed by Deucravacitinib 6 mg QD ATP: Deucravacitinib 6 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 26 (3.85%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 26 (3.85%)
    0 / 16 (0.00%)
    0 / 32 (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
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PBO-Controlled: Deucravacitinib 6mg QD PBO-Controlled: Deucravacitinib 6mgBID Placebo ATP: PBO followed by Deucravacitinib 6 mg BID ATP: Deucravacitinib 6 mg BID ATP: PBO followed by Deucravacitinib 6 mg QD ATP: Deucravacitinib 6 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 32 (75.00%)
    26 / 31 (83.87%)
    16 / 31 (51.61%)
    14 / 15 (93.33%)
    14 / 26 (53.85%)
    13 / 16 (81.25%)
    15 / 32 (46.88%)
    Investigations
    Weight increased
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 32 (9.38%)
    3 / 31 (9.68%)
    3 / 31 (9.68%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    3 / 32 (9.38%)
         occurrences all number
    3
    3
    4
    0
    0
    0
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 26 (3.85%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    1
    0
    Mass
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Mouth ulceration
         subjects affected / exposed
    2 / 32 (6.25%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    3
    2
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 32 (3.13%)
    4 / 31 (12.90%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    3 / 32 (9.38%)
    4 / 31 (12.90%)
    1 / 31 (3.23%)
    2 / 15 (13.33%)
    2 / 26 (7.69%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    4
    7
    1
    2
    2
    1
    0
    Amalgam tattoo
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    1 / 26 (3.85%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    0
    Food poisoning
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    2 / 15 (13.33%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    2 / 26 (7.69%)
    0 / 16 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    1
    2
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    5 / 32 (15.63%)
    4 / 31 (12.90%)
    3 / 31 (9.68%)
    4 / 15 (26.67%)
    0 / 26 (0.00%)
    3 / 16 (18.75%)
    0 / 32 (0.00%)
         occurrences all number
    5
    4
    3
    4
    0
    3
    0
    Pruritus
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    Eczema
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    2 / 16 (12.50%)
    0 / 32 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    2
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    2
    Rosacea
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 31 (6.45%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    0
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    2
    Muscle spasms
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Infections and infestations
    Nail infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 26 (3.85%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    Influenza
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 26 (3.85%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    2 / 26 (7.69%)
    0 / 16 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    2
    0
    0
    1
    2
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    5 / 32 (15.63%)
    6 / 31 (19.35%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    5
    6
    1
    1
    0
    0
    0
    Cystitis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    2
    Conjunctivitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 32 (15.63%)
    8 / 31 (25.81%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    6 / 26 (23.08%)
    2 / 16 (12.50%)
    2 / 32 (6.25%)
         occurrences all number
    5
    13
    0
    1
    10
    2
    4
    COVID-19
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    2 / 15 (13.33%)
    1 / 26 (3.85%)
    0 / 16 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    3
    2
    0
    2
    1
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    2 / 31 (6.45%)
    1 / 15 (6.67%)
    1 / 26 (3.85%)
    1 / 16 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    1
    2
    3
    1
    1
    2
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 31 (9.68%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 26 (3.85%)
    0 / 16 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    1
    7
    0
    0
    1
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 32 (6.25%)
    4 / 31 (12.90%)
    4 / 31 (12.90%)
    4 / 15 (26.67%)
    5 / 26 (19.23%)
    4 / 16 (25.00%)
    4 / 32 (12.50%)
         occurrences all number
    2
    5
    4
    7
    5
    5
    4
    Tonsillitis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    1 / 26 (3.85%)
    1 / 16 (6.25%)
    2 / 32 (6.25%)
         occurrences all number
    2
    0
    0
    1
    1
    1
    2
    Sinusitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    2 / 26 (7.69%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    1 / 26 (3.85%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 26 (0.00%)
    0 / 16 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Aug 2023
    The primary purpose of this amendment is to incorporate changes based on comments received from United States Food and Drug Administration (US FDA) as well as to add clarifications based on feedback from study investigators. Language from the Japan-specific Amendment 01, related to the interpretation of hepatitis B virus test results to assess eligibility and to clarify expectations for assessments and sample collections, has been incorporated into this global amendment. Other edits were incorporated throughout the protocol to correct minor errors, add clarity, and improve consistency. Key changes are summarized below. This protocol amendment applies to all participants.

    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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    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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