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    Clinical Trial Results:
    A Phase 3b/4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of Deucravacitinib in Participants with Moderate-To-Severe Scalp Psoriasis (Psoriatyk Scalp)

    Summary
    EudraCT number
    		 2022-000797-26
    Trial protocol
    		 FR   DE  
    Global end of trial date
    17 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM011-220
    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 Nov 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare efficacy and safety of deucravacitinib versus placebo in participants with moderate-to-severe scalp psoriasis
    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 participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 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
    United Kingdom: 11
    Country: Number of subjects enrolled
    United States: 57
    Country: Number of subjects enrolled
    Germany: 42
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    France: 7
    Worldwide total number of subjects
    154
    EEA total number of subjects
    86
    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)
    137
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 154 randomized and treated

    Period 1
    Period 1 title
    Placebo Controlled: Week 0 - 16
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Deucravacitinib
    Arm description
    		 Deucravacitinib 6 mg daily (QD)
    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 daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching Deucravacitinib daily (QD)
    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
    daily

    Number of subjects in period 1
    		Deucravacitinib Placebo
    Started
    103
    51
    Completed
    94
    45
    Not completed
    9
    6
         Consent withdrawn by subject
    3
    2
         Adverse event, non-fatal
    4
    2
         Other reasons
    -
    2
         Lost to follow-up
    1
    -
         Lack of efficacy
    1
    -
    Period 2
    Period 2 title
    Active Treatment: Week 16 - Week 52
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Deucravacitinib
    Arm description
    		 Deucravacitinib 6 mg daily (QD)
    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 daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching Deucravacitinib daily (QD)
    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
    daily

    Number of subjects in period 2
    		Deucravacitinib Placebo
    Started
    94
    45
    Completed
    80
    39
    Not completed
    14
    6
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    4
    2
         Adverse event, non-fatal
    4
    -
         Non-compliance with protocol
    -
    1
         Lost to follow-up
    1
    2
         Lack of efficacy
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Deucravacitinib
    Reporting group description
    		 Deucravacitinib 6 mg daily (QD)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching Deucravacitinib daily (QD)

    Reporting group values
    		 Deucravacitinib Placebo Total
    Number of subjects
    		 103 51 154
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.8 ( 15.70 ) 43.2 ( 13.08 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 45 20 65
        Male
    		 58 31 89
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 3 2 5
        Black or African American
    		 5 2 7
        Native Hawaiian or other pacific islander
    		 0 0 0
        White
    		 93 47 140
        Other
    		 2 0 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 8 14
        Not Hispanic or Latino
    		 95 43 138
        Unknown or Not Reported
    		 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Deucravacitinib
    Reporting group description
    		 Deucravacitinib 6 mg daily (QD)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching Deucravacitinib daily (QD)
    Reporting group title
    Deucravacitinib
    Reporting group description
    		 Deucravacitinib 6 mg daily (QD)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching Deucravacitinib daily (QD)

    Primary: Percentage of Participants with a Scalp-specific Physician Global Assessment Score of 0 or 1 (ss-PGA 0/1) at Week 16

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    End point title
    		 Percentage of Participants with a Scalp-specific Physician Global Assessment Score of 0 or 1 (ss-PGA 0/1) at Week 16
    End point description
    ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.
    End point type
    Primary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    103
    51
    Units: Percentage of responders
    number (confidence interval 95%)
        Full Analysis Set
    48.5 (38.6 to 58.6)
    13.7 (5.7 to 26.3)
        Patient sub-population (s-PGA ≥ 3)
    50.0 (39.6 to 60.4)
    12.8 (4.8 to 25.7)
    Statistical analysis title
    		 Odds Ratio (OR)
    Statistical analysis description
    Patient sub-population (s-PGA ≥ 3)
    Comparison groups
    Deucravacitinib v Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 18.4
    Statistical analysis title
    		 Odds Ratio (OR)
    Statistical analysis description
    Full Analysis Set
    Comparison groups
    Deucravacitinib v Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 15.3

    Secondary: Percentage of Participants with a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16

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    End point title
    		 Percentage of Participants with a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16
    End point description
    PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms. NA= -99999
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    103
    51
    Units: Percentage of responders
    number (confidence interval 95%)
        Full Analysis Set
    38.8 (29.4 to 48.9)
    2.0 (-99999 to 10.4)
        Patient sub-population (s-PGA ≥ 3)
    40.6 (30.7 to 51.1)
    2.1 (-99999 to 11.3)
    Statistical analysis title
    		 Odds Ratio (OR)
    Statistical analysis description
    Patient sub-population (s-PGA ≥ 3)
    Comparison groups
    Deucravacitinib v Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    37.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.4
         upper limit
    		 317.6
    Statistical analysis title
    		 Odds Ratio (OR)
    Statistical analysis description
    Full Analysis Set
    Comparison groups
    Deucravacitinib v Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    40.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.6
         upper limit
    		 352

    Secondary: Change from Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16

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    End point title
    		 Change from Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16
    End point description
    Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 11-point horizontal scale anchored at 0 and 10 with 0 representing “no scalp itch” and 10 representing “worst scalp itch imaginable.”. Overall severity of a participant’s itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching within the past 24 hours.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    103
    51
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Full Analysis Set
    -3.2 ( 2.95 )
    -0.7 ( 2.27 )
        Patient sub-population (s-PGA ≥ 3)
    -3.3 ( 2.87 )
    -0.9 ( 2.29 )
    Statistical analysis title
    		 Adjusted mean difference
    Statistical analysis description
    Patient sub-population (s-PGA ≥ 3)
    Comparison groups
    Deucravacitinib v Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 analysis of covariance model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.44
    Statistical analysis title
    		 Adjusted mean difference
    Statistical analysis description
    Full Analysis Set
    Comparison groups
    Deucravacitinib v Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 analysis of covariance model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.42

    Secondary: Percentage of Participants with a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16

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    End point title
    		 Percentage of Participants with a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16
    End point description
    s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    96
    47
    Units: Percentage of responders
        number (confidence interval 95%)
    51.0 (40.6 to 61.4)
    4.3 (0.5 to 14.5)
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    Deucravacitinib v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    23.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.4
         upper limit
    		 105.6

    Secondary: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
    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 that does not necessarily have a causal relation with this treatment.
    End point type
    Secondary
    End point timeframe
    From week 0 through week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    103
    51
    Units: Participants
    73
    26
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade

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    End point title
    		 Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade
    End point description
    Laboratory test results summary of Worst toxicity grade in SI units for hematology and chemistry using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1= mild and asymptomatic; Grade 2= moderate requiring minimal, local or noninvasive intervention; Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= events are usually severe enough to require hospitalization. 99999=NA
    End point type
    Secondary
    End point timeframe
    Week 0 through Week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    103
    51
    Units: Participants
        Basophils (10^9/L) Grade 1-4
    0
    0
        Eosinophils (10^9/L) Grade 1
    4
    2
        Eosinophils (10^9/L) Grade 2-4
    0
    0
        Hemoglobin (g/L) Grade 1
    5
    4
        Hemoglobin (g/L) Grade 2
    1
    0
        Hemoglobin (g/L) Grade 3
    0
    0
        Leukocytes (10^9/L) Grade 1
    8
    1
        Leukocytes (10^9/L) Grade 2
    0
    1
        Leukocytes (10^9/L) Grade 3-4
    0
    0
        Lymphocytes Blood Test (10^9/L) Grade 1
    1
    1
        Lymphocytes Blood Test (10^9/L) Grade 2
    1
    0
        Lymphocytes Blood Test (10^9/L) Grade 3-4
    0
    0
        Lymphocytes Plasma Test (10^9/L) Grade 1
    1
    1
        Lymphocytes Plasma Test (10^9/L) Grade 2
    1
    0
        Lymphocytes Plasma Test (10^9/L) Grade 3-4
    0
    0
        Neutrophils (x10^9/L) Grade 1
    5
    2
        Neutrophils (x10^9/L) Grade 2-4
    0
    0
        Platelets (10^9/L) Grade 1-4
    0
    0
        Alanine Aminotransferase (U/L) Grade 1
    8
    8
        Alanine Aminotransferase (U/L) Grade 2
    0
    1
        Alanine Aminotransferase (U/L) Grade 3-4
    0
    0
        Albumin (g/L) Grade 1-4
    0
    0
        Alkaline Phosphatase (U/L) Grade 1
    1
    2
        Alkaline Phosphatase (U/L) Grade 2-4
    0
    0
        Aspartate Aminotransferase (U/L) Grade 1
    5
    5
        Aspartate Aminotransferase (U/L) Grade 2-4
    0
    0
        Bilirubin (umol/L) Grade 1
    5
    3
        Bilirubin (umol/L) Grade 2
    1
    0
        Bilirubin (umol/L) Grade 3-4
    0
    0
        Calcium (mmol/L) Grade 1
    1
    0
        Calcium (mmol/L) Grade 2-4
    0
    0
        Chloride (mmol/L) Grade 1-4
    0
    0
        Cholesterol (mmol/L) Grade 1
    5
    0
        Cholesterol (mmol/L) Grade 2-4
    0
    0
        Creatine Kinase (U/L) Grade 1-4
    0
    99999
        Creatinine (umol/L) Grade 1
    3
    0
        Creatinine (umol/L) Grade 2
    1
    0
        Creatinine (umol/L) Grade 3-4
    0
    0
        Direct Bilirubin (umol/L) Grade 1-4
    0
    0
        Glucose (mmol/L) Grade 1
    2
    0
        Glucose (mmol/L) Grade 2-4
    0
    0
        Lactate Dehydrogenase (U/L) Grade 1-4
    0
    99999
        Magnesium (mmol/L) Grade 1-4
    0
    99999
        Phosphate (mmol/L) Grade 1-4
    0
    0
        Potassium (mmol/L) Grade 1
    6
    2
        Potassium (mmol/L) Grade 2
    8
    1
        Potassium (mmol/L) Grade 3
    0
    1
        Potassium (mmol/L) Grade 4
    0
    0
        Sodium (mmol/L) Grade 1
    0
    2
        Sodium (mmol/L) Grade 2
    1
    0
        Sodium (mmol/L) Grade 3-4
    0
    0
        Triglycerides (mmol/L) Grade 1
    27
    7
        Triglycerides (mmol/L) Grade 2
    2
    3
        Triglycerides (mmol/L) Grade 3
    1
    0
        Triglycerides (mmol/L) Grade 4
    0
    1
        Urate (umol/L) Grade 1-4
    0
    99999
        Urea Nitrogen (mmol/L) Grade 1-4
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)
    End point description
    A 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.
    End point type
    Secondary
    End point timeframe
    From week 0 through week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    103
    51
    Units: Participants
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests

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    End point title
    		 Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests
    End point description
    Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal
    End point type
    Secondary
    End point timeframe
    Week 0 through Week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    103
    51
    Units: Participants
        ALT or AST > 3 X ULN
    0
    1
        ALT or AST > 5 X ULN
    0
    0
        Total Bilirubin > 2 X ULN
    0
    0
        ALT/AST>3XULN, total bilirubin>2XULN on same day
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormalities in Vital Signs

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    End point title
    		 Number of Participants with Abnormalities in Vital Signs
    End point description
    Number of participants with abnormalities in vital signs including heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP).
    End point type
    Secondary
    End point timeframe
    Week 0 through Week 16
    End point values
    		 Deucravacitinib Placebo
    Number of subjects analysed
    103
    51
    Units: Participants
        HR (BEATS/MIN): >100 AND CHANGE FROM BASELINE>30
    0
    0
        HR (BEATS/MIN) <55 AND CHANGE FROM BASELINE<-15
    1
    3
        HR (BEATS/MIN): NOT REPORTED
    0
    0
        SBP (MMHG) >140 AND CHANGE FROM BASELINE >20
    3
    4
        SBP (MMHG) <90 AND CHANGE FROM BASELINE <-20
    0
    0
        SBP (MMHG): NOT REPORTED
    0
    0
        DBP (MMHG) >90 AND CHANGE FROM BASELINE >10
    8
    3
        DBP (MMHG): <55 AND CHANGE FROM BASELINE <-10
    0
    2
        DBP (MMHG): NOT REPORTED
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were assessed for deaths (all-cause) from their first dose to their study completion (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Placebo Controlled - Deucravacitinib
    Reporting group description
    		 Deucravacitinib 6 mg daily (QD)

    Reporting group title
    Active Treatment – Placebo - Deucravacitinib
    Reporting group description
    		 Deucravacitinib 6 mg daily (QD)

    Reporting group title
    Active Treatment - Deucravacitinib - Deucravacitinib
    Reporting group description
    		 Deucravacitinib 6 mg daily (QD)

    Reporting group title
    Placebo Controlled - Placebo
    Reporting group description
    		 Placebo matching Deucravacitinib daily (QD)

    Serious adverse events
    		 Placebo Controlled - Deucravacitinib Active Treatment – Placebo - Deucravacitinib Active Treatment - Deucravacitinib - Deucravacitinib Placebo Controlled - Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 45 (0.00%)
    4 / 94 (4.26%)
    1 / 51 (1.96%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 45 (0.00%)
    1 / 94 (1.06%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 45 (0.00%)
    0 / 94 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 45 (0.00%)
    0 / 94 (0.00%)
    1 / 51 (1.96%)
         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
    Myocardial infarction
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 45 (0.00%)
    1 / 94 (1.06%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 45 (0.00%)
    1 / 94 (1.06%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ligament disorder
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 45 (0.00%)
    1 / 94 (1.06%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Controlled - Deucravacitinib Active Treatment – Placebo - Deucravacitinib Active Treatment - Deucravacitinib - Deucravacitinib Placebo Controlled - Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 103 (45.63%)
    16 / 45 (35.56%)
    42 / 94 (44.68%)
    14 / 51 (27.45%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 103 (7.77%)
    1 / 45 (2.22%)
    2 / 94 (2.13%)
    2 / 51 (3.92%)
         occurrences all number
    9
    1
    2
    3
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    2 / 103 (1.94%)
    0 / 45 (0.00%)
    4 / 94 (4.26%)
    3 / 51 (5.88%)
         occurrences all number
    2
    0
    4
    3
    Acne
         subjects affected / exposed
    10 / 103 (9.71%)
    1 / 45 (2.22%)
    1 / 94 (1.06%)
    0 / 51 (0.00%)
         occurrences all number
    12
    1
    1
    0
    Infections and infestations
    Acne pustular
         subjects affected / exposed
    6 / 103 (5.83%)
    0 / 45 (0.00%)
    3 / 94 (3.19%)
    0 / 51 (0.00%)
         occurrences all number
    6
    0
    3
    0
    COVID-19
         subjects affected / exposed
    6 / 103 (5.83%)
    4 / 45 (8.89%)
    12 / 94 (12.77%)
    4 / 51 (7.84%)
         occurrences all number
    6
    4
    12
    4
    Nasopharyngitis
         subjects affected / exposed
    16 / 103 (15.53%)
    8 / 45 (17.78%)
    22 / 94 (23.40%)
    7 / 51 (13.73%)
         occurrences all number
    20
    12
    25
    7
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 103 (11.65%)
    3 / 45 (6.67%)
    11 / 94 (11.70%)
    2 / 51 (3.92%)
         occurrences all number
    13
    3
    13
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 May 2022
    Endpoints Classification Update
    05 Dec 2022
    Schedule of Activity Update
    23 May 2023
    exclusion criteria update

    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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