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    Clinical Trial Results:
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

    Summary
    EudraCT number
    		 2019-004878-26
    Trial protocol
    		 DE   NL   PL  
    Global end of trial date
    29 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jun 2024
    First version publication date
    15 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM011-127
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04613518
    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
    24 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to estimate the effect of BMS-986165 on clinical response at Week 12.
    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
    15 Mar 2021
    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: 5
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    38
    EEA total number of subjects
    25
    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)
    38
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 BMS-986165 6 mg BID arm was removed under Protocol Amendment 02.

    Period 1
    Period 1 title
    Double-Blind Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-986165 12 mg BID
    Arm description
    		 Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
    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
    12 mg twice daily

    Arm title
    		 BMS-986165 6 mg BID
    Arm description
    		 Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period.
    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
    12 mg twice daily

    Arm title
    		 Placebo BID PO
    Arm description
    		 Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
    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 matching BMS-986165 twice daily

    Number of subjects in period 1
    		BMS-986165 12 mg BID BMS-986165 6 mg BID Placebo BID PO
    Started
    26
    4
    8
    Completed
    19
    3
    7
    Not completed
    7
    1
    1
         Participant request to discontinue treatment
    1
    -
    -
         Participant withdrew consent
    1
    1
    -
         Adverse event, non-fatal
    2
    -
    1
         Other Reasons
    2
    -
    -
         Lack of efficacy
    1
    -
    -
    Period 2
    Period 2 title
    Open-Label Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-986165 12 mg BID
    Arm description
    		 Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
    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
    12 mg twice daily

    Arm title
    		 BMS-986165 6 mg BID
    Arm description
    		 Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period.
    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
    12 mg twice daily

    Arm title
    		 Placebo BID PO
    Arm description
    		 Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
    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 matching BMS-986165 twice daily

    Number of subjects in period 2
    		BMS-986165 12 mg BID BMS-986165 6 mg BID Placebo BID PO
    Started
    19
    3
    7
    Completed
    11
    0
    1
    Not completed
    8
    3
    6
         Participant request to discontinue treatment
    1
    -
    -
         Participant withdrew consent
    1
    -
    3
         Adverse event, non-fatal
    1
    -
    3
         Other Reasons
    1
    -
    -
         Administrative reason by sponsor
    4
    -
    -
         Lack of efficacy
    -
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BMS-986165 12 mg BID
    Reporting group description
    		 Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.

    Reporting group title
    BMS-986165 6 mg BID
    Reporting group description
    		 Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period.

    Reporting group title
    Placebo BID PO
    Reporting group description
    		 Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.

    Reporting group values
    		 BMS-986165 12 mg BID BMS-986165 6 mg BID Placebo BID PO Total
    Number of subjects
    		 26 4 8 38
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 26 4 8 38
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 41.8 ( 14.4 ) 28.8 ( 6.7 ) 38.0 ( 15.1 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 12 2 2 16
        Male
    		 14 2 6 22
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 1
        Asian
    		 1 0 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 25 3 7 35
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 24 3 6 33
        Unknown or Not Reported
    		 2 1 2 5

    End points

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    End points reporting groups
    Reporting group title
    BMS-986165 12 mg BID
    Reporting group description
    		 Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.

    Reporting group title
    BMS-986165 6 mg BID
    Reporting group description
    		 Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period.

    Reporting group title
    Placebo BID PO
    Reporting group description
    		 Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
    Reporting group title
    BMS-986165 12 mg BID
    Reporting group description
    		 Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.

    Reporting group title
    BMS-986165 6 mg BID
    Reporting group description
    		 Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period.

    Reporting group title
    Placebo BID PO
    Reporting group description
    		 Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.

    Primary: Percentage of Participants in Clinical Response at Week 12

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    End point title
    		 Percentage of Participants in Clinical Response at Week 12 [1]
    End point description
    Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment) -A decrease from baseline in the modified Mayo score of ≥ 2 points, and - A decrease from baseline in the modified Mayo score ≥ 30%, and - A decrease in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components: - Stool frequency (SF) subscore (0 to 3) - Rectal bleeding (RB) subscore (0 to 3) - Endoscopic (ES) subscore (0 to 3) Analyzed for all randomized participants.
    End point type
    Primary
    End point timeframe
    At week 12
    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: BMS-986165 6 mg BID was removed from the protocol and not in scope of the endpoints.
    End point values
    		 BMS-986165 12 mg BID Placebo BID PO
    Number of subjects analysed
    26
    8
    Units: Percentage of participants
        number (confidence interval 95%)
    53.8 (33.4 to 73.4)
    50.0 (15.7 to 84.3)
    Statistical analysis title
    		 DIFFERENCE VS PLACEBO
    Comparison groups
    BMS-986165 12 mg BID v Placebo BID PO
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.7
         upper limit
    		 43.4

    Primary: Number of Participants Experiencing Adverse Events (AEs)

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    End point title
    		 Number of Participants Experiencing Adverse Events (AEs) [2] [3]
    End point description
    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Analyzed for all randomized participants who receive at least 1 dose of double-blind study treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period.
    End point type
    Primary
    End point timeframe
    From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    [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: BMS-986165 6 mg BID was removed from the protocol and not in scope of the endpoints.
    End point values
    		 BMS-986165 12 mg BID Placebo BID PO
    Number of subjects analysed
    26
    8
    Units: Participants
        Double-Blind Treatment Period
    21
    6
        Open-Label Treatment Period
    15
    6
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants Experiencing Serious Adverse Events (SAEs) [4] [5]
    End point description
    An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Analyzed for all randomized participants who receive at least 1 dose of double-blind study treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period.
    End point type
    Primary
    End point timeframe
    From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    [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: BMS-986165 6 mg BID was removed from the protocol and not in scope of the endpoints.
    End point values
    		 BMS-986165 12 mg BID Placebo BID PO
    Number of subjects analysed
    26
    8
    Units: Participants
        Double-Blind Treatment Period
    4
    1
        Open-Label Treatment Period
    1
    1
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

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    End point title
    		 Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [6] [7]
    End point description
    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.Analyzed for all randomized participants who receive at least 1 dose of double-blind study treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period.
    End point type
    Primary
    End point timeframe
    From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: BMS-986165 6 mg BID was removed from the protocol and not in scope of the endpoints.
    End point values
    		 BMS-986165 12 mg BID Placebo BID PO
    Number of subjects analysed
    26
    8
    Units: Participants
        Double-Blind Treatment Period
    2
    0
        Open-Label Treatment Period
    1
    3
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Adverse Events of Special Interest (AEIs)

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    End point title
    		 Number of Participants Experiencing Adverse Events of Special Interest (AEIs) [8] [9]
    End point description
    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19. Analyzed for all randomized participants who receive at least 1 dose of double-blind study treatment.
    End point type
    Primary
    End point timeframe
    From first dose to 52 weeks after first dose
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    [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: BMS-986165 6 mg BID was removed from the protocol and not in scope of the endpoints.
    End point values
    		 BMS-986165 12 mg BID Placebo BID PO
    Number of subjects analysed
    26
    8
    Units: Participants
        Skin Events
    15
    5
        Influenza
    1
    2
        Herpes Viral Infections
    0
    0
        Opportunistic Infections
    0
    0
        Tuberculosis
    0
    0
        Cardiovascular events
    1
    0
        Malignancy
    0
    0
        COVID-19
    3
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    BMS-986165 12 mg BID (Double-Blind Treatment Period)
    Reporting group description
    		 Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period.

    Reporting group title
    Placebo BID PO (Double-Blind Treatment Period)
    Reporting group description
    		 Participants receive placebo for a 12-week double-blind treatment period.

    Reporting group title
    BMS-986165 6 mg BID (Open-Label Treatment Period)
    Reporting group description
    		 Eligible participants that move into the 40-week open-label extension period receive BMS-986165 6 mg BID PO.

    Reporting group title
    BMS-986165 6 mg BID (Double-Blind Treatment Period)
    Reporting group description
    		 Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period.

    Serious adverse events
    		 BMS-986165 12 mg BID (Double-Blind Treatment Period) Placebo BID PO (Double-Blind Treatment Period) BMS-986165 6 mg BID (Open-Label Treatment Period) BMS-986165 6 mg BID (Double-Blind Treatment Period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 8 (12.50%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 8 (0.00%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 8 (0.00%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 8 (12.50%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 8 (0.00%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteroides bacteraemia
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 8 (0.00%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BMS-986165 12 mg BID (Double-Blind Treatment Period) Placebo BID PO (Double-Blind Treatment Period) BMS-986165 6 mg BID (Open-Label Treatment Period) BMS-986165 6 mg BID (Double-Blind Treatment Period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 26 (73.08%)
    6 / 8 (75.00%)
    20 / 29 (68.97%)
    4 / 4 (100.00%)
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Injury, poisoning and procedural complications
    Wrist fracture
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 8 (0.00%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 8 (0.00%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 8 (0.00%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 8 (0.00%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 8 (0.00%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Colitis ulcerative
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nausea
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    0
    1
    Mouth ulceration
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 8 (0.00%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tongue dry
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 8 (0.00%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    8 / 26 (30.77%)
    1 / 8 (12.50%)
    5 / 29 (17.24%)
    3 / 4 (75.00%)
         occurrences all number
    8
    1
    5
    3
    Dermatitis acneiform
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Rash
         subjects affected / exposed
    4 / 26 (15.38%)
    0 / 8 (0.00%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 8 (0.00%)
    1 / 29 (3.45%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 8 (0.00%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 8 (0.00%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Influenza
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 8 (0.00%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    2
    0
    COVID-19
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 8 (0.00%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 8 (12.50%)
    2 / 29 (6.90%)
    0 / 4 (0.00%)
         occurrences all number
    3
    1
    2
    0
    Metabolism and nutrition disorders
    Magnesium deficiency
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    0 / 29 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 8 (12.50%)
    1 / 29 (3.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 May 2021
    Added instructions and measures to be taken in relation to SARS-CoV-2 infection. Added clarification regarding additional research sample collection and use. Removed prohibition of medical marijuana. Added additional hematology laboratory tests to be conducted. Removed the endoscopic global severity score. Clarified the definitions and male contraception requirements.
    24 Feb 2022
    Removed the BMS-986165 6 mg BID treatment arm and Clarified future treatment regimen. Replaced mandatory corticosteroid taper by Week 24 with instruction that subjects should attempt to initiate a taper at least once by Week 24 and removed criterion for treatment failure if a subject is not corticosteroid-free by Week 24.

    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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