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

    Summary
    EudraCT number
    		 2018-001926-25
    Trial protocol
    		 GB   FR   ES   DE   PL   Outside EU/EEA  
    Global end of trial date
    02 Sep 2020

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM011-046
    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
    15 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigate Efficacy and Safety of BMS-986165 versus Placebo and Active Comparator in Subjects with 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
    07 Aug 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
    Canada: 62
    Country: Number of subjects enrolled
    China: 6
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Japan: 66
    Country: Number of subjects enrolled
    Poland: 182
    Country: Number of subjects enrolled
    Russian Federation: 69
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 26
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Taiwan: 8
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    United States: 218
    Worldwide total number of subjects
    666
    EEA total number of subjects
    192
    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)
    605
    From 65 to 84 years
    61
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 666 participants randomized and 665 treated

    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
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
    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 received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
    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
    Twice a day

    Arm title
    		 Apremilast
    Arm description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Apremilast
    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
    332
    166
    168
    Completed
    332
    165
    168
    Not completed
    0
    1
    0
         d/c study due to incorrect randomization
    -
    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
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
    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 received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52
    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
    Twice a day

    Arm title
    		 Apremilast
    Arm description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Apremilast
    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
    332
    165
    168
    Completed
    307
    145
    145
    Not completed
    25
    20
    23
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    4
    3
    3
         Adverse event, non-fatal
    5
    7
    10
         Other reasons
    8
    5
    3
         Lost to follow-up
    7
    2
    4
         Protocol deviation
    1
    1
    2
         Lack of efficacy
    -
    1
    1
    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
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
    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
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Apremilast
    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
    452
    145
    Completed
    442
    141
    Not completed
    10
    4
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    1
         Other reasons
    3
    -
         Lost to follow-up
    -
    2
         Lack of efficacy
    3
    -
         Protocol deviation
    1
    -
    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
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast
    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
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Apremilast
    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 4
    		BMS-986165 Apremilast
    Started
    496
    87
    Completed
    444
    83
    Not completed
    52
    4
         Consent withdrawn by subject
    10
    -
         Adverse event, non-fatal
    8
    1
         Site terminated by sponsor
    2
    -
         Other reasons
    19
    2
         Lost to follow-up
    5
    1
         Lack of efficacy
    6
    -
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BMS-986165
    Reporting group description
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52

    Reporting group title
    Apremilast
    Reporting group description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52

    Reporting group values
    		 BMS-986165 Placebo Apremilast Total
    Number of subjects
    		 332 166 168 666
    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)
    		 306 141 158 605
        From 65-84 years
    		 26 25 10 61
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 45.9 ( 13.71 ) 47.9 ( 13.98 ) 44.7 ( 12.06 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 102 53 58 213
        Male
    		 230 113 110 453
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 267 128 139 534
        Black or African American
    		 2 3 1 6
        Asian
    		 59 34 28 121
        American Indian or Alaska Native
    		 0 0 0 0
        Native Hawaiian or other Pacific Islander
    		 0 0 0 0
        Other
    		 4 1 0 5
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 50 26 30 106
        Not Hispanic or Latino
    		 282 140 138 560
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    BMS-986165
    Reporting group description
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52

    Reporting group title
    Apremilast
    Reporting group description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
    Reporting group title
    BMS-986165
    Reporting group description
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo week 0 - week 16 and then switched in a blinded manner to BMS-986165 6 mg daily (QD) through week 52

    Reporting group title
    Apremilast
    Reporting group description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
    Reporting group title
    BMS-986165
    Reporting group description
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast

    Reporting group title
    Apremilast
    Reporting group description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52
    Reporting group title
    BMS-986165
    Reporting group description
    		 BMS-986165 6 mg daily (QD) week 0 - week 52. At week 16, participants were switched in blinded manner from placebo. At week 24, participants who did not achieve PASI 50 were switched in a blinded manner from Apremilast

    Reporting group title
    Apremilast
    Reporting group description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing, continuing through week 24. At week 24, participants who achieved Psoriasis Area and Severity Index (PASI) 50 continued with regimen in a blinded manner and participants who did not achieve PASI 50 were switched in a blinded manner to BMS-986165 6 mg QD through week 52

    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 of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). 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 2-point improvement from baseline using the non-responder imputation (NRI) method that 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
    332
    166
    Units: Participants
    178
    12
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    18.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.51
         upper limit
    		 36.81

    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
    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The 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 that 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. Baseline is defined as the measurement at the randomization visit (Week 0).
    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
    332
    166
    Units: Participants
    194
    21
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.49
         upper limit
    		 18.95

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

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    End point title
    		 Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16
    End point description
    PSSD with a 24-hour recall period is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). PSSD 0 is the response as a number of participants who experience a PSSD symptom score that is derived from the average of the scores and determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    305
    149
    158
    Units: Participants
    24
    1
    7
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    454
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0013
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    13.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.77
         upper limit
    		 105.5
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1702
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 4.42

    Secondary: The Number of Participants who Achieve a 90% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) 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 (PASI) Score at Week 16 (PASI 90)
    End point description
    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The 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 that 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. Baseline is defined as the measurement at the randomization visit (Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    332
    166
    168
    Units: Participants
    118
    7
    33
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    500
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.51
         upper limit
    		 3.6
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    16.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.91
         upper limit
    		 37.72

    Secondary: The Number of Participants with a static Physician's 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's Global Assessment Score of 0 at Week 16 (sPGA 0)
    End point description
    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). 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 that 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
    332
    166
    168
    Units: Participants
    58
    1
    8
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    39.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.29
         upper limit
    		 295.75
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    500
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.07
         upper limit
    		 9.84

    Secondary: The Number of Participants who Achieve a 100% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo 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 (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100) [3]
    End point description
    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The 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 that 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. Baseline is defined as the measurement at the randomization visit (Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline and 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
    332
    166
    Units: Participants
    47
    1
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    31.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.09
         upper limit
    		 239.36

    Secondary: Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16

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    End point title
    		 Change from Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 [4]
    End point description
    Change from baseline in PSSD score. PSSD with a 24-hour recall period is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participants-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. PSSD symptom score is derived from the average of the scores. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A modified observation carried forward (mBOCF) approach will be used for missing data. the baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs. Baseline is defined as the measurement at the randomization visit (Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline and 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 Apremilast
    Number of subjects analysed
    306
    158
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -29.4 ( 24.43 )
    -22.8 ( 23.40 )
    Statistical analysis title
    		 Adjusted Mean Difference
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    464
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.8
         upper limit
    		 -4.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    2

    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) [5]
    End point description
    DLQI is a participant-reported quality of life index which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week before questionnaire. Each question is scored on a scale of 0 to 3 by a tick box (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 response as a number of participants who experience DLQI score of 0 or 1 among participants with a baseline DLQI score >=2.
    End point type
    Secondary
    End point timeframe
    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 Placebo
    Number of subjects analysed
    322
    160
    Units: Participants
    132
    17
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    482
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.46
         upper limit
    		 10.53

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

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    End point title
    		 Number of Participants with a Physician's Global Assessment-Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 [6]
    End point description
    PGA-F overall condition of the fingernails 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.
    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 Placebo
    Number of subjects analysed
    43
    34
    Units: Participants
    9
    3
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1049
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 10.96

    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) [7]
    End point description
    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The 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 that 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. Baseline is defined as the measurement at the randomization visit (Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    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
    332
    168
    Units: Participants
    194
    59
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    500
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.78
         upper limit
    		 3.91

    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
    ss-PGA is a 5-point scale that evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness. The higher ss-PGA score denotes to more severe disease activity (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 that determines scalp lesions severity as 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score >=3.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BMS-986165 Placebo Apremilast
    Number of subjects analysed
    209
    121
    110
    Units: Participants
    147
    21
    43
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    319
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.21
         upper limit
    		 6.04
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Placebo
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.69
         upper limit
    		 21.25

    Secondary: The Number of Participants with a static Physician's 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's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1) [8]
    End point description
    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). 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 2-point improvement from baseline using the non-responder imputation (NRI) method that 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
    [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
    332
    168
    Units: Participants
    178
    54
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    500
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 3.78

    Secondary: The Number of Participants with a static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (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 Apremilast at Week 24 (sPGA 0/1) [9]
    End point description
    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). 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 2-point improvement from baseline using the non-responder imputation (NRI) method that 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
    [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
    332
    168
    Units: Participants
    195
    52
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    500
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.16
         upper limit
    		 4.83

    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 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 Apremilast at Week 24 (PASI 75) [10]
    End point description
    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The 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 that 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. Baseline is defined as the measurement at the randomization visit (Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point.
    End point values
    		 BMS-986165 Apremilast
    Number of subjects analysed
    332
    168
    Units: Participants
    230
    64
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    500
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.53
         upper limit
    		 5.6

    Secondary: The Number of Participants who Achieve a 90% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) 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 (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90) [11]
    End point description
    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The 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 that 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. Baseline is defined as the measurement at the randomization visit (Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    Notes
    [11] - 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
    332
    168
    Units: Participants
    140
    37
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    500
    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
    		 1.71
         upper limit
    		 4.05

    Secondary: The Number of Participants with a static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (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 Apremilast at Week 52 and at Week 24 (sPGA 0/1) [12]
    End point description
    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. 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 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). 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 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 52 or who have missing week 52 endpoint data for any reason.
    End point type
    Secondary
    End point timeframe
    Week 52 and Week 24
    Notes
    [12] - 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
    332
    167
    Units: Participants
    151
    37
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.96
         upper limit
    		 4.69

    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 52 and 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 Apremilast at Week 52 and at Week 24 (PASI 75) [13]
    End point description
    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The 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 that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52 and Week 24
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only pre-specified arms planned for this end point.
    End point values
    		 BMS-986165 Apremilast
    Number of subjects analysed
    332
    167
    Units: Participants
    187
    51
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.06
         upper limit
    		 4.69

    Secondary: The Number of Participants who Achieve a 90% Improvement from Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and 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 (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 90) [14]
    End point description
    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The 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 that will be used for participants who discontinue treatment or study prior to week 52, or who have missing week 52 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52 and Week 24
    Notes
    [14] - 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
    332
    167
    Units: Participants
    103
    26
    Statistical analysis title
    		 Odds Ratio (OR)
    Comparison groups
    BMS-986165 v Apremilast
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.55
         upper limit
    		 4.19

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Deaths (all causes) was assessed from first dose to study completion (up to approximately 24 months). SAEs and NSAEs were assessed from first dose to 30 days following last dose (up to approximately 12 months)
    Adverse event reporting additional description
    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
    23.0
    Reporting groups
    Reporting group title
    BMS Week 0 up to Week 16
    Reporting group description
    		 BMS-986165 6 mg daily (QD) week 0 - week 16

    Reporting group title
    Placebo Week 0 up to Week 16
    Reporting group description
    		 Participants received placebo week 0 - week 16

    Reporting group title
    Apremilast Week 0 up to Week 16
    Reporting group description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing week 0 - week 16

    Reporting group title
    BMS Week 0 up to Week 52
    Reporting group description
    		 BMS-986165 6 mg daily (QD) week 0 - week 52

    Reporting group title
    Placebo Week 0 up to Week 52
    Reporting group description
    		 Participants received placebo week 0 - week 52

    Reporting group title
    Apremilast Week 0 up to Week 52
    Reporting group description
    		 Apremilast titrated from 10 mg daily (QD) to 30 mg twice a day (BID) over the first 5 days of dosing week 0 - week 52

    Serious adverse events
    		 BMS Week 0 up to Week 16 Placebo Week 0 up to Week 16 Apremilast Week 0 up to Week 16 BMS 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
    7 / 332 (2.11%)
    9 / 165 (5.45%)
    4 / 168 (2.38%)
    31 / 531 (5.84%)
    9 / 165 (5.45%)
    6 / 168 (3.57%)
         number of deaths (all causes)
    0
    1
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Hodgkin's disease
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    General disorders and administration site conditions
    Hernia perforation
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Incarcerated hernia
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Organising pneumonia
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Pulmonary embolism
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Fracture displacement
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Hand fracture
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Lower limb fracture
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Tendon injury
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Toxicity to various agents
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Wrist fracture
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Angina unstable
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    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 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Hypertensive heart disease
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    2 / 531 (0.38%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Ventricular tachycardia
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
         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
    Status epilepticus
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Transient ischaemic attack
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Blood and lymphatic system disorders
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Abdominal pain upper
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
    0 / 531 (0.00%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
         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
    Enterocutaneous fistula
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Intra-abdominal fluid collection
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Small intestinal perforation
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    2 / 531 (0.38%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Psoriasis
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Stress urinary incontinence
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Ureterolithiasis
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    COVID-19
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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 pneumonia
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
         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
    Carbuncle
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Cellulitis
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
    0 / 531 (0.00%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
         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
    Diverticulitis
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (0.00%)
    0 / 531 (0.00%)
    1 / 165 (0.61%)
    0 / 168 (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
    Infectious mononucleosis
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Localised infection
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
    0 / 531 (0.00%)
    0 / 165 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Pilonidal cyst
         subjects affected / exposed
    0 / 332 (0.00%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Pyelonephritis
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 165 (0.00%)
    0 / 168 (0.00%)
    1 / 531 (0.19%)
    0 / 165 (0.00%)
    0 / 168 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BMS Week 0 up to Week 16 Placebo Week 0 up to Week 16 Apremilast Week 0 up to Week 16 BMS 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
    76 / 332 (22.89%)
    24 / 165 (14.55%)
    60 / 168 (35.71%)
    197 / 531 (37.10%)
    24 / 165 (14.55%)
    80 / 168 (47.62%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 332 (1.81%)
    0 / 165 (0.00%)
    6 / 168 (3.57%)
    14 / 531 (2.64%)
    0 / 165 (0.00%)
    9 / 168 (5.36%)
         occurrences all number
    7
    0
    6
    18
    0
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 332 (4.82%)
    5 / 165 (3.03%)
    17 / 168 (10.12%)
    35 / 531 (6.59%)
    5 / 165 (3.03%)
    23 / 168 (13.69%)
         occurrences all number
    19
    5
    21
    46
    5
    27
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    13 / 332 (3.92%)
    6 / 165 (3.64%)
    17 / 168 (10.12%)
    30 / 531 (5.65%)
    6 / 165 (3.64%)
    19 / 168 (11.31%)
         occurrences all number
    15
    6
    21
    32
    6
    25
    Nausea
         subjects affected / exposed
    7 / 332 (2.11%)
    4 / 165 (2.42%)
    19 / 168 (11.31%)
    7 / 531 (1.32%)
    4 / 165 (2.42%)
    21 / 168 (12.50%)
         occurrences all number
    7
    4
    20
    8
    4
    23
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    21 / 332 (6.33%)
    7 / 165 (4.24%)
    14 / 168 (8.33%)
    96 / 531 (18.08%)
    7 / 165 (4.24%)
    26 / 168 (15.48%)
         occurrences all number
    22
    7
    15
    123
    7
    30
    Upper respiratory tract infection
         subjects affected / exposed
    21 / 332 (6.33%)
    6 / 165 (3.64%)
    3 / 168 (1.79%)
    50 / 531 (9.42%)
    6 / 165 (3.64%)
    6 / 168 (3.57%)
         occurrences all number
    21
    6
    3
    57
    6
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2018
    Clarified Psoriasis Symptoms and Signs Diary Timeline (PSSD)
    20 Nov 2018
    Updated Exclusion Criteria
    14 May 2019
    Updated Randomization target for each country
    06 Jun 2019
    Revised the testing order (hierarchy) of key secondary endpoints
    17 Dec 2019
    added and updated relevant protocol deviation criteria for the Per Protocol Set

    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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