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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis

    Summary
    EudraCT number
    		 2016-002481-31
    Trial protocol
    		 LV  
    Global end of trial date
    16 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2018
    First version publication date
    01 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM011-011
    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
    16 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main study objectives were to compare the proportion of subjects with moderate to severe psoriasis in experiencing a 75% improvement as measured by reduction in Psoriasis Area and Severity Index (PASI) score after 12 weeks of treatment between doses of BMS-986165 and placebo and to assess the safety and tolerability of multiple oral doses of BMS-986165 in subjects with moderate to severe 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 subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 2016
    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
    Germany: 32
    Country: Number of subjects enrolled
    Latvia: 21
    Country: Number of subjects enrolled
    Poland: 98
    Country: Number of subjects enrolled
    Canada: 39
    Country: Number of subjects enrolled
    United States: 37
    Country: Number of subjects enrolled
    Australia: 16
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Japan: 22
    Worldwide total number of subjects
    267
    EEA total number of subjects
    151
    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)
    248
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 340 subjects were enrolled, 268 subjects were randomized in the study; One subject was randomized but did not receive study drug due to being lost to follow-up

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo for BMS-986165
    Arm type
    		 Placebo

    Investigational medicinal product name
    BMS-986165 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0 mg

    Arm title
    		 BMS-986165 3MG QOD
    Arm description
    		 BMS-986165 3mg capsules Every Other Day
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165 3 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3mg Every Other Day

    Arm title
    		 BMS-986165 3MG QD
    Arm description
    		 BMS-986165 3mg capsules Every Day
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165 3 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3mg Every Day

    Arm title
    		 BMS-986165 3MG BID
    Arm description
    		 BMS-986165 3mg capsules Twice Daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165 3 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3mg Twice Daily

    Arm title
    		 BMS-986165 6MG BID
    Arm description
    		 BMS-986165 6mg capsules Twice Daily
    Arm type
    		 Experimental

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

    Arm title
    		 BMS-986165 12MG QD
    Arm description
    		 BMS-986165 12mg capsules Every Day
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165 12 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    12 mg Every Day

    Number of subjects in period 1
    		Placebo BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD
    Started
    45
    44
    44
    45
    45
    44
    Completed
    31
    34
    36
    42
    39
    42
    Not completed
    14
    10
    8
    3
    6
    2
         Reason not provided by investigator
    1
    -
    1
    -
    -
    -
         Subject request to discontinue treatment
    4
    3
    3
    -
    1
    -
         Consent withdrawn by subject
    1
    2
    -
    1
    -
    -
         Adverse event, non-fatal
    2
    1
    2
    1
    3
    1
         Lost to follow-up
    1
    -
    1
    1
    2
    -
         Poor/non-compliance
    -
    -
    1
    -
    -
    -
         Lack of efficacy
    5
    4
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for BMS-986165

    Reporting group title
    BMS-986165 3MG QOD
    Reporting group description
    		 BMS-986165 3mg capsules Every Other Day

    Reporting group title
    BMS-986165 3MG QD
    Reporting group description
    		 BMS-986165 3mg capsules Every Day

    Reporting group title
    BMS-986165 3MG BID
    Reporting group description
    		 BMS-986165 3mg capsules Twice Daily

    Reporting group title
    BMS-986165 6MG BID
    Reporting group description
    		 BMS-986165 6mg capsules Twice Daily

    Reporting group title
    BMS-986165 12MG QD
    Reporting group description
    		 BMS-986165 12mg capsules Every Day

    Reporting group values
    		 Placebo BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD Total
    Number of subjects
    		 45 44 44 45 45 44 267
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 43 44 40 38 44 39 248
        From 65-84 years
    		 2 0 4 7 1 5 19
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 46.4 ( 11.93 ) 41.0 ( 11.8 ) 45.0 ( 13.77 ) 45.6 ( 15.10 ) 42.8 ( 12.90 ) 46.6 ( 11.62 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 8 8 14 19 10 14 73
        Male
    		 37 36 30 26 35 30 194
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 0 1 1 3
        Asian
    		 5 6 5 5 9 6 36
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 0 1 0 1 0 0 2
        White
    		 40 35 39 39 35 37 225
        More than one race
    		 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 1 0 0 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for BMS-986165

    Reporting group title
    BMS-986165 3MG QOD
    Reporting group description
    		 BMS-986165 3mg capsules Every Other Day

    Reporting group title
    BMS-986165 3MG QD
    Reporting group description
    		 BMS-986165 3mg capsules Every Day

    Reporting group title
    BMS-986165 3MG BID
    Reporting group description
    		 BMS-986165 3mg capsules Twice Daily

    Reporting group title
    BMS-986165 6MG BID
    Reporting group description
    		 BMS-986165 6mg capsules Twice Daily

    Reporting group title
    BMS-986165 12MG QD
    Reporting group description
    		 BMS-986165 12mg capsules Every Day

    Primary: The percentage of subjects with moderate to severe psoriasis experiencing a 75% improvement (reduction from baseline) in PASI score (PASI-75 response rate) on Day 85 (Week 12)

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    End point title
    		 The percentage of subjects with moderate to severe psoriasis experiencing a 75% improvement (reduction from baseline) in PASI score (PASI-75 response rate) on Day 85 (Week 12)
    End point description
    Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 85
    End point values
    		 Placebo BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD
    Number of subjects analysed
    45
    44
    44
    45
    45
    44
    Units: Percentage
    number (confidence interval 95%)
        % of subjects with PASI-75 response rate on Day 85
    6.7 (1.4 to 18.3)
    9.1 (2.5 to 21.7)
    38.6 (24.4 to 54.5)
    68.9 (53.4 to 81.8)
    66.7 (51.0 to 80.0)
    75.0 (59.7 to 86.8)
    Statistical analysis title
    		 P-value (Chi-Squared) BMS-986165 3MG QOD vs pbo
    Comparison groups
    Placebo v BMS-986165 3MG QOD
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4873 [1]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test.
    Statistical analysis title
    		 P-value (Chi-Squared) BMS-986165 3MG QD vs pbo
    Comparison groups
    Placebo v BMS-986165 3MG QD
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0003 [2]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [2] - P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test.
    Statistical analysis title
    		 P-value (Chi-Squared) BMS-986165 3 MG BID vs pbo
    Comparison groups
    Placebo v BMS-986165 3MG BID
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 P-value (Chi-Squared) BMS-986165 6MG BID vs pbo
    Comparison groups
    Placebo v BMS-986165 6MG BID
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001 [3]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [3] - P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test.
    Statistical analysis title
    		 P-value (Chi-Squared) BMS-986165 12MG QD vs pbo
    Comparison groups
    Placebo v BMS-986165 12MG QD
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001 [4]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [4] - P-value is from the Fishers Exact if at least one cell count is <5. Otherwise, p-value is from the Chi-Square test.

    Primary: Number of subjects with Adverse Events

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    End point title
    		 Number of subjects with Adverse Events [5]
    End point description
    The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation
    End point type
    Primary
    End point timeframe
    Day 1 to day 115
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for this endpoint
    End point values
    		 Placebo BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD
    Number of subjects analysed
    45
    44
    44
    45
    45
    44
    Units: Subjects
        No. of subjects with SAEs
    1
    1
    1
    1
    0
    0
        No. of subjects with AEs|
    24
    26
    25
    29
    36
    34
        No. of subjects who discontinued due to AEs|
    2
    1
    2
    1
    3
    1
    No statistical analyses for this end point

    Secondary: Percentage of subjects on Day 85 with PASI-50, PASI-90, PASI-100.

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    End point title
    		 Percentage of subjects on Day 85 with PASI-50, PASI-90, PASI-100.
    End point description
    Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 90 and PASI 100 responses on Day 85. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders. PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders. PASI 100 response: patients who achieved ≥ 100% improvement (reduction) in PASI score compared to baseline were defined as PASI 100 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 85
    End point values
    		 Placebo BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD
    Number of subjects analysed
    45
    44
    44
    45
    45
    44
    Units: Percentage
    number (confidence interval 95%)
        % of subjects with PASI-50 at Day 85|
    31.1 (18.2 to 46.6)
    43.2 (28.3 to 59.0)
    68.2 (52.4 to 81.4)
    91.1 (78.8 to 97.5)
    77.8 (62.9 to 88.8)
    88.6 (75.4 to 96.2)
        % of subjects with PASI-90 at Day 85|
    2.2 (0.1 to 11.8)
    6.8 (1.4 to 18.7)
    15.9 (6.6 to 30.1)
    44.4 (29.6 to 60.0)
    44.4 (29.6 to 60.0)
    43.2 (28.3 to 59.0)
        % of subjects with PASI-100 at Day 85|
    0 (0.0 to 7.9)
    2.3 (0.1 to 12.0)
    0 (0.0 to 8.0)
    8.9 (2.5 to 21.2)
    17.8 (8.0 to 32.1)
    25.0 (13.2 to 40.3)
    No statistical analyses for this end point

    Secondary: Percentage of subjects on Day 85 with sPGA score of 0 or 1 (sPGA0/1 response rate).

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    End point title
    		 Percentage of subjects on Day 85 with sPGA score of 0 or 1 (sPGA0/1 response rate).
    End point description
    Percentage of subjects achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) on Day 85. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 85
    End point values
    		 Placebo BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD
    Number of subjects analysed
    45
    44
    44
    45
    45
    44
    Units: Percentage
    number (confidence interval 95%)
        % of subjects on Day 85 with sPGA 0/1 response
    6.7 (1.4 to 18.3)
    20.5 (9.8 to 35.3)
    38.6 (24.4 to 54.5)
    75.6 (60.5 to 87.1)
    64.4 (48.8 to 78.1)
    75.0 (59.7 to 86.8)
    No statistical analyses for this end point

    Secondary: Change from baseline in DLQI scores on Day 85

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    End point title
    		 Change from baseline in DLQI scores on Day 85
    End point description
    The DLQI is a subject 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. Each question is scored on a scale of 0 to 3 by a tick box: "not at all", "a little", "a lot", or "very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment)
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 85
    End point values
    		 Placebo BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD
    Number of subjects analysed
    34
    38
    41
    43
    40
    43
    Units: Score
    arithmetic mean (confidence interval 95%)
        Change from baseline in DLQI scores on Day 85
    -2.85 (-4.33 to -1.37)
    -3.76 (-5.15 to -2.38)
    -6.07 (-8.07 to -4.08)
    -9.67 (-11.42 to -7.93)
    -8.38 (-10.72 to -6.03)
    -10.16 (-12.27 to -8.06)
    No statistical analyses for this end point

    Secondary: Change from baseline in BSA on Day 85

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    End point title
    		 Change from baseline in BSA on Day 85
    End point description
    Measurement of psoriasis body surface area (BSA) involvement is estimated using the handprint method with the size of a patient’s handprint representing ~1% of body surface area involved.The total BSA = 100% with breakdown by body region as follows: head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), trunk including axillae and groin = 30% (30 handprints), lower extremities including buttocks = 40% (40 handprints). A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Day 85 score; a positive change from Baseline therefore indicates improvement.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 85
    End point values
    		 Placebo BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD
    Number of subjects analysed
    34
    38
    41
    43
    40
    43
    Units: Percentage
    arithmetic mean (confidence interval 95%)
        Change from baseline in BSA on Day 85
    -7.71 (-11.88 to -3.54)
    -5.50 (-8.17 to -2.83)
    -12.59 (-18.28 to -6.89)
    -18.60 (-23.69 to -13.52)
    -17.23 (-20.85 to -13.60)
    -15.16 (-18.64 to -11.69)
    No statistical analyses for this end point

    Secondary: Trough observed plasma concentration of BMS-986165 (Ctrough)

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    End point title
    		 Trough observed plasma concentration of BMS-986165 (Ctrough) [6]
    End point description
    Pharmacokinetics of BMS-986165 were derived from plasma concentration versus time data. Ctrough= Trough observed plasma concentration
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29, 57, 85
    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 summary statistics were planned for this endpoint
    End point values
    		 BMS-986165 3MG QOD BMS-986165 3MG QD BMS-986165 3MG BID BMS-986165 6MG BID BMS-986165 12MG QD
    Number of subjects analysed
    44
    44
    44
    45
    44
    Units: ng/mL
    arithmetic mean (standard deviation)
        Ctrough of BMS-986165
    2.024 ( 3.7061 )
    3.145 ( 3.1588 )
    14.819 ( 9.1410 )
    26.257 ( 14.6483 )
    17.824 ( 22.7536 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose of study therapy and within 30 days of the last dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo capsules orally for 12 weeks.

    Reporting group title
    BMS 3 mg QOD
    Reporting group description
    		 Subjects received BMS-986165 3 milligram (mg) capsules orally once every other day (QOD) for 12 weeks.

    Reporting group title
    BMS 3 mg QD
    Reporting group description
    		 Subjects received BMS-986165 3 mg capsules orally once daily (QD) for 12 weeks.

    Reporting group title
    BMS 3 mg BID
    Reporting group description
    		 Subjects received BMS-986165 3 mg capsules orally twice daily (BID) for 12 weeks.

    Reporting group title
    BMS 6 mg BID
    Reporting group description
    		 Subjects received BMS-986165 6 mg capsules orally BID for 12 weeks.

    Reporting group title
    BMS 12 mg QD
    Reporting group description
    		 Subjects received BMS-986165 12 mg capsules orally QD for 12 weeks.

    Serious adverse events
    		 Placebo BMS 3 mg QOD BMS 3 mg QD BMS 3 mg BID BMS 6 mg BID BMS 12 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Eye injury
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    Dizziness
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    0 / 44 (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
    Haemorrhagic anaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo BMS 3 mg QOD BMS 3 mg QD BMS 3 mg BID BMS 6 mg BID BMS 12 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 45 (26.67%)
    14 / 44 (31.82%)
    18 / 44 (40.91%)
    15 / 45 (33.33%)
    25 / 45 (55.56%)
    18 / 44 (40.91%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 45 (0.00%)
    3 / 45 (6.67%)
    5 / 44 (11.36%)
         occurrences all number
    1
    0
    1
    0
    3
    6
    Blood immunoglobulin E increased
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 44 (6.82%)
    2 / 44 (4.55%)
    0 / 45 (0.00%)
    2 / 45 (4.44%)
    2 / 44 (4.55%)
         occurrences all number
    1
    3
    2
    0
    2
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 45 (4.44%)
    4 / 44 (9.09%)
    4 / 44 (9.09%)
    3 / 45 (6.67%)
    3 / 45 (6.67%)
    2 / 44 (4.55%)
         occurrences all number
    2
    4
    5
    3
    3
    2
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    3 / 45 (6.67%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    3
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    2 / 45 (4.44%)
    2 / 45 (4.44%)
    4 / 44 (9.09%)
         occurrences all number
    2
    2
    1
    3
    2
    5
    Nausea
         subjects affected / exposed
    2 / 45 (4.44%)
    4 / 44 (9.09%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    1 / 45 (2.22%)
    2 / 44 (4.55%)
         occurrences all number
    2
    4
    0
    1
    1
    2
    Toothache
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    1 / 45 (2.22%)
    3 / 45 (6.67%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    1
    1
    3
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    1 / 45 (2.22%)
    2 / 45 (4.44%)
    4 / 44 (9.09%)
         occurrences all number
    0
    1
    0
    1
    2
    4
    Pruritus
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    1 / 45 (2.22%)
    3 / 45 (6.67%)
    2 / 44 (4.55%)
         occurrences all number
    2
    0
    1
    1
    3
    2
    Psoriasis
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    2 / 45 (4.44%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    2
    1
    3
    2
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 44 (2.27%)
    5 / 44 (11.36%)
    5 / 45 (11.11%)
    7 / 45 (15.56%)
    3 / 44 (6.82%)
         occurrences all number
    2
    1
    6
    6
    8
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 44 (4.55%)
    3 / 44 (6.82%)
    1 / 45 (2.22%)
    4 / 45 (8.89%)
    1 / 44 (2.27%)
         occurrences all number
    0
    2
    3
    2
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The limitations of this phase 2 trial include its small sample size and short duration; these results warrant confirmation in a larger trial of longer duration
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    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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