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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study with Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2018-001925-24
    Trial protocol
    		 GB   FR   CZ   ES   HU   PL   FI   IT  
    Global end of trial date
    30 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2022
    First version publication date
    25 Oct 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM011-047
    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
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@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
    22 Dec 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess whether BMS-986165 is superior to placebo at Week 16 in the treatment of subjects with moderate-to severe plaque 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
    26 Jul 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 58
    Country: Number of subjects enrolled
    Canada: 95
    Country: Number of subjects enrolled
    Czechia: 60
    Country: Number of subjects enrolled
    Finland: 9
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Hungary: 68
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    New Zealand: 7
    Country: Number of subjects enrolled
    Poland: 267
    Country: Number of subjects enrolled
    Puerto Rico: 7
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    Sweden: 15
    Country: Number of subjects enrolled
    United Kingdom: 47
    Country: Number of subjects enrolled
    United States: 322
    Worldwide total number of subjects
    1020
    EEA total number of subjects
    479
    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)
    912
    From 65 to 84 years
    108
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1020 participants randomized and 1018 treated.1 Participant stopped treatment after Week 16 and re-entered in treatment period Week 24-52.

    Period 1
    Period 1 title
    Pre-treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-986165
    Arm description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    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
    		 Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.
    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 to match

    Arm title
    		 Apremilast
    Arm description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Apremalist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg used for titration day 1 through day 3 morning dose. 20 mg used for titration day 3 through day 5 morning dose. 30 mg from day 5 evening dose onwards.

    Number of subjects in period 1
    		BMS-986165 Placebo Apremilast
    Started
    511
    255
    254
    Completed
    510
    254
    254
    Not completed
    1
    1
    0
         Randomized but not treated
    1
    1
    -
    Period 2
    Period 2 title
    Treatment Week 0 - Week 16
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-986165
    Arm description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    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
    		 Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.
    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 to match

    Arm title
    		 Apremilast
    Arm description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Apremalist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg used for titration day 1 through day 3 morning dose. 20 mg used for titration day 3 through day 5 morning dose. 30 mg from day 5 evening dose onwards.

    Number of subjects in period 2
    		BMS-986165 Placebo Apremilast
    Started
    510
    254
    254
    Completed
    456
    212
    217
    Not completed
    54
    42
    37
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    14
    9
    9
         Adverse event, non-fatal
    11
    7
    12
         Pregnancy
    -
    -
    1
         Non-compliance with protocol
    5
    2
    1
         Other reasons
    13
    9
    7
         Lost to follow-up
    5
    6
    2
         Lack of efficacy
    6
    9
    4
    Period 3
    Period 3 title
    Treatment Week 16 - Week 24
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-986165
    Arm description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg daily

    Arm title
    		 Apremilast
    Arm description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Apremalist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg used for titration day 1 through day 3 morning dose. 20 mg used for titration day 3 through day 5 morning dose. 30 mg from day 5 evening dose onwards.

    Number of subjects in period 3
    		BMS-986165 Apremilast
    Started
    668
    217
    Discontinued (re-entered at Week 24-52)
    1 [1]
    0 [2]
    Completed
    643
    208
    Not completed
    25
    9
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    7
    2
         Pregnancy
    1
    1
         Non-compliance with protocol
    3
    1
         Other reasons
    2
    3
         Lost to follow-up
    2
    -
         Lack of efficacy
    8
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 1 Participant stopped treatment after week 16 and re-entered in treatment period Week 24-52
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 1 Participant stopped treatment after week 16 and re-entered in treatment period Week 24-52.
    Period 4
    Period 4 title
    Treatment Week 24 - Week 52
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-986165
    Arm description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    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
    		 Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.
    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 to match

    Number of subjects in period 4
    		BMS-986165 Placebo
    Started
    604
    247
    Completed
    535
    214
    Not completed
    69
    33
         Consent withdrawn by subject
    8
    6
         Adverse event, non-fatal
    14
    7
         Pregnancy
    -
    1
         Non-compliance with protocol
    2
    -
         Other reasons
    28
    7
         Lost to follow-up
    9
    4
         Lack of efficacy
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BMS-986165
    Reporting group description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.

    Reporting group title
    Apremilast
    Reporting group description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.

    Reporting group values
    		 BMS-986165 Placebo Apremilast Total
    Number of subjects
    		 511 255 254 1020
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 457 229 226 912
        From 65-84 years
    		 54 26 28 108
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        median (standard deviation)
    		 46.9 ( 13.37 ) 47.3 ( 13.57 ) 46.4 ( 13.28 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 175 74 97 346
        Male
    		 336 181 157 674
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 58 29 29 116
        Not Hispanic or Latino
    		 445 226 223 894
        Unknown or Not Reported
    		 8 0 2 10
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 474 232 229 935
        Black or African American
    		 8 9 9 26
        Asian
    		 24 8 12 44
        American Indian or Alaska Native
    		 2 2 3 7
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Other
    		 3 4 1 8

    End points

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    End points reporting groups
    Reporting group title
    BMS-986165
    Reporting group description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.

    Reporting group title
    Apremilast
    Reporting group description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
    Reporting group title
    BMS-986165
    Reporting group description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.

    Reporting group title
    Apremilast
    Reporting group description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
    Reporting group title
    BMS-986165
    Reporting group description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.

    Reporting group title
    Apremilast
    Reporting group description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
    Reporting group title
    BMS-986165
    Reporting group description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.

    Primary: The Number of Participants with a static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)

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    End point title
    		 The Number of Participants with a static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) [1]
    End point description
    The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA 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). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Primary
    End point timeframe
    Week 16
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Placebo
    Number of subjects analysed
    511
    255
    Units: Participants
    253
    22
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.54
         upper limit
    		 17

    Primary: The Number of Participants who Achieve a 75% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)

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    End point title
    		 The Number of Participants who Achieve a 75% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) [2]
    End point description
    The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Primary
    End point timeframe
    Baseline and Week 16
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Placebo
    Number of subjects analysed
    511
    255
    Units: Participants
    271
    24
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.65
         upper limit
    		 16.55

    Secondary: The Number of Participants who Achieve a 90% Improvement from Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)

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    End point title
    		 The Number of Participants who Achieve a 90% Improvement from Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)
    End point description
    The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    511
    255
    254
    Units: Participants
    138
    7
    46
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.45
         upper limit
    		 23.93
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    765
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0046
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.18
         upper limit
    		 2.56

    Secondary: The Number of Participants who Achieve a 100% Improvement from Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)

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    End point title
    		 The Number of Participants who Achieve a 100% Improvement from Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)
    End point description
    The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    511
    255
    254
    Units: Participants
    52
    3
    11
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    9.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.89
         upper limit
    		 29.4
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    765
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0051
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 5

    Secondary: The Number of Participants with a static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)

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    End point title
    		 The Number of Participants with a static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)
    End point description
    The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA 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). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    511
    255
    254
    Units: Participants
    80
    3
    16
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    766
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    14.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.62
         upper limit
    		 45.11
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    765
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.61
         upper limit
    		 5.03

    Secondary: Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16

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    End point title
    		 Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16
    End point description
    The PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from an average of the scores. A higher score indicates more severe disease. Baseline is defined as the measurement at the randomization visit (Week 0). A modified baseline observation carried forward (mBOCF) approach will be used in participants with missing data. Missing values will have the last valid observation carried forward (including the baseline value as applicable).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    466
    239
    233
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -28.9 ( 25.22 )
    -4.2 ( 19.58 )
    -21.5 ( 25.44 )
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    705
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -23.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.9
         upper limit
    		 -20.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.67
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    699
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.5
         upper limit
    		 -3.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.68

    Secondary: Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16

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    End point title
    		 Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
    End point description
    Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1 using the non-responder imputation (NRI) method.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    466
    238
    232
    Units: Participants
    35
    3
    10
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    704
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0005
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.94
         upper limit
    		 21.15
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    698
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0928
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 3.71

    Secondary: The Number of Participants with a Scalp Specific Physician’s Global Assessment (ss-PGA) Score 0 or 1 at Week 16 (ss-PGA 0/1)

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    End point title
    		 The Number of Participants with a Scalp Specific Physician’s Global Assessment (ss-PGA) Score 0 or 1 at Week 16 (ss-PGA 0/1)
    End point description
    The scalp specific Physician’s Global Assessment (ss-PGA) evaluates scalp lesions 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. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 . Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    305
    173
    166
    Units: Participants
    182
    30
    61
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.34
         upper limit
    		 10.81
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    471
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.77
         upper limit
    		 3.91

    Secondary: The Number of Participants with a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)

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    End point title
    		 The Number of Participants with a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1) [3]
    End point description
    The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Placebo
    Number of subjects analysed
    495
    246
    Units: Participants
    186
    24
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    741
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.42
         upper limit
    		 8.47

    Secondary: The Number of Participants with a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)

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    End point title
    		 The Number of Participants with a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1) [4]
    End point description
    The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Placebo
    Number of subjects analysed
    69
    38
    Units: Participants
    14
    3
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0621
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 11.79

    Secondary: The Number of Participants with a Palmoplantar Physician’s Global Assessment (pp-PGA) Score of 0 or 1 at Week 16 (pp-PGA 0/1)

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    End point title
    		 The Number of Participants with a Palmoplantar Physician’s Global Assessment (pp-PGA) Score of 0 or 1 at Week 16 (pp-PGA 0/1)
    End point description
    The palmoplantar Physician’s Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score ≥ 3.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    39
    17
    20
    Units: Participants
    18
    4
    8
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3793
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 5.56
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6692
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 7.46

    Secondary: The Number of Participants who Achieve a 75% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)

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    End point title
    		 The Number of Participants who Achieve a 75% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75) [5]
    End point description
    The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Apremilast
    Number of subjects analysed
    511
    254
    Units: Participants
    271
    101
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    765
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0004
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 2.41

    Secondary: The Number of Participants with a static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)

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    End point title
    		 The Number of Participants with a static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1) [6]
    End point description
    The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA 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). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Apremilast
    Number of subjects analysed
    511
    254
    Units: Participants
    253
    86
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    765
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.45
         upper limit
    		 2.78

    Secondary: Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders

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    End point title
    		 Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
    End point description
    Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline. The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 -4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Note: 99999 = N/A (Insufficient number of participants with events)
    End point type
    Secondary
    End point timeframe
    From Week 24 to Week 52 (up to approximately 28 weeks)
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    145
    150
    95
    Units: Days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    197.0 (125.0 to 99999)
    Statistical analysis title
    		 Log Rank
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval

    Secondary: The Number of Participants with a static Physician Global Assessment (sPGA) score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)

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    End point title
    		 The Number of Participants with a static Physician Global Assessment (sPGA) score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1) [7]
    End point description
    The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA 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). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Apremilast
    Number of subjects analysed
    504
    254
    Units: Participants
    251
    75
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    758
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.78
         upper limit
    		 3.43

    Secondary: The Number of Participants who Achieve a 75% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)

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    End point title
    		 The Number of Participants who Achieve a 75% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75) [8]
    End point description
    The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Apremilast
    Number of subjects analysed
    504
    254
    Units: Participants
    296
    96
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    758
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.78
         upper limit
    		 3.36

    Secondary: The Number of Participants who Achieve a 90% Improvement from Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)

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    End point title
    		 The Number of Participants who Achieve a 90% Improvement from Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90) [9]
    End point description
    The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0). Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point
    End point values
    		 BMS-986165 Apremilast
    Number of subjects analysed
    504
    254
    Units: Participants
    164
    50
    Statistical analysis title
    		 Odds Ratio
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    758
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.43
         upper limit
    		 3.01

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were assessed for Death (all causes) from their first dose until the study was completed (up to approximately 60 weeks). SAEs and NSAEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks)
    Adverse event reporting additional description
    The total number of subjects exposed represents all participants that received at least 1 dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    BMS-986165 (Week 0 up to Week 16)
    Reporting group description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).

    Reporting group title
    Placebo (Week 0 up to Week 16)
    Reporting group description
    		 Participants receive Placebo by oral administration once daily (QD).

    Reporting group title
    Apremilast (Week 0 up to Week 16)
    Reporting group description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards.

    Reporting group title
    BMS-986165 (Week 0 up to Week 52)
    Reporting group description
    		 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).

    Reporting group title
    Placebo (Week 0 up to Week 52)
    Reporting group description
    		 Participants receive Placebo by oral administration once daily (QD).

    Reporting group title
    Apremilast (Week 0 up to Week 52)
    Reporting group description
    		 Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) -10 mg used for titration Day 1 through Day 3 morning dose -20 mg used for titration Day 3 evening dose through Day 5 morning dose. -30 mg from Day 5 evening dose onwards.

    Serious adverse events
    		 BMS-986165 (Week 0 up to Week 16) Placebo (Week 0 up to Week 16) Apremilast (Week 0 up to Week 16) BMS-986165 (Week 0 up to Week 52) Placebo (Week 0 up to Week 52) Apremilast (Week 0 up to Week 52)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 510 (1.57%)
    3 / 254 (1.18%)
    1 / 254 (0.39%)
    24 / 833 (2.88%)
    5 / 501 (1.00%)
    3 / 254 (1.18%)
         number of deaths (all causes)
    1
    0
    1
    2
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
    0 / 833 (0.00%)
    0 / 501 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Vascular disorders
    Malignant hypertension
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 510 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    1 / 501 (0.20%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Thrombosis
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    0 / 501 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    1 / 501 (0.20%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 510 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    1 / 501 (0.20%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory failure
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 510 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    1 / 501 (0.20%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Congenital, familial and genetic disorders
    Gastrointestinal arteriovenous malformation
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
    0 / 833 (0.00%)
    0 / 501 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Atrial fibrillation
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Cardiac failure
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Pericardial effusion
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    1 / 501 (0.20%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Ischaemic stroke
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
    0 / 833 (0.00%)
    0 / 501 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Anal polyp
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    1 / 501 (0.20%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    1 / 254 (0.39%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Skin and subcutaneous tissue disorders
    Excessive granulation tissue
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    COVID-19
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 510 (0.00%)
    1 / 254 (0.39%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    1 / 501 (0.20%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Mycoplasma infection
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    0 / 833 (0.00%)
    0 / 501 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    3 / 833 (0.36%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Purulence
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Sepsis
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular graft infection
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 510 (0.20%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Diabetes mellitus
         subjects affected / exposed
    0 / 510 (0.00%)
    0 / 254 (0.00%)
    0 / 254 (0.00%)
    1 / 833 (0.12%)
    0 / 501 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BMS-986165 (Week 0 up to Week 16) Placebo (Week 0 up to Week 16) Apremilast (Week 0 up to Week 16) BMS-986165 (Week 0 up to Week 52) Placebo (Week 0 up to Week 52) Apremilast (Week 0 up to Week 52)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    114 / 510 (22.35%)
    61 / 254 (24.02%)
    86 / 254 (33.86%)
    249 / 833 (29.89%)
    97 / 501 (19.36%)
    98 / 254 (38.58%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    22 / 510 (4.31%)
    14 / 254 (5.51%)
    28 / 254 (11.02%)
    45 / 833 (5.40%)
    16 / 501 (3.19%)
    30 / 254 (11.81%)
         occurrences all number
    27
    17
    31
    53
    19
    38
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    24 / 510 (4.71%)
    19 / 254 (7.48%)
    33 / 254 (12.99%)
    39 / 833 (4.68%)
    22 / 501 (4.39%)
    35 / 254 (13.78%)
         occurrences all number
    26
    20
    36
    50
    23
    38
    Nausea
         subjects affected / exposed
    7 / 510 (1.37%)
    3 / 254 (1.18%)
    23 / 254 (9.06%)
    13 / 833 (1.56%)
    6 / 501 (1.20%)
    26 / 254 (10.24%)
         occurrences all number
    7
    3
    23
    13
    6
    27
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    55 / 510 (10.78%)
    29 / 254 (11.42%)
    23 / 254 (9.06%)
    133 / 833 (15.97%)
    47 / 501 (9.38%)
    28 / 254 (11.02%)
         occurrences all number
    66
    33
    24
    172
    55
    33
    Upper respiratory tract infection
         subjects affected / exposed
    25 / 510 (4.90%)
    11 / 254 (4.33%)
    14 / 254 (5.51%)
    74 / 833 (8.88%)
    27 / 501 (5.39%)
    21 / 254 (8.27%)
         occurrences all number
    28
    12
    14
    89
    31
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2019
    1) Randomization in each country will be targeted to approximately 35% or less of the total sample size. 2) Added the ‘Time to relapse until Week 52’ endpoint

    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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