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    Clinical Trial Results:
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2017-001203-79
    Trial protocol
    		 HU   PL   DE   ES   RO  
    Global end of trial date
    28 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IM011-021
    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
    14 Jan 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of BMS-986165 in subjects with Systemic Lupus Erythematosus
    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
    21 Sep 2017
    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
    Japan: 19
    Country: Number of subjects enrolled
    Argentina: 19
    Country: Number of subjects enrolled
    Brazil: 32
    Country: Number of subjects enrolled
    Colombia: 24
    Country: Number of subjects enrolled
    Mexico: 33
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    United States: 85
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Poland: 51
    Country: Number of subjects enrolled
    Romania: 14
    Country: Number of subjects enrolled
    Russian Federation: 44
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Taiwan: 16
    Worldwide total number of subjects
    363
    EEA total number of subjects
    84
    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)
    354
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 363 Participants randomized and treated

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo PO BID
    Arm type
    		 Placebo

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

    Arm title
    		 BMS-986165 3 mg
    Arm description
    		 BMS-986165 3 mg PO BID
    Arm type
    		 Experimental

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

    Arm title
    		 BMS-986165 6 mg
    Arm description
    		 BMS-986165 6 mg PO BID
    Arm type
    		 Experimental

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

    Arm title
    		 BMS-986165 12 mg
    Arm description
    		 BMS-986165 12 mg PO QD
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Intratumoral use, Oral use
    Dosage and administration details
    12 mg PO QD

    Number of subjects in period 1
    		Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Started
    90
    91
    93
    89
    Completed
    66
    71
    76
    62
    Not completed
    24
    20
    17
    27
         Consent withdrawn by subject
    8
    4
    4
    4
         Adverse event, non-fatal
    3
    8
    6
    12
         Other Reasons
    2
    5
    5
    4
         Pregnancy
    2
    1
    -
    1
         Lost to follow-up
    2
    -
    -
    2
         Lack of efficacy
    7
    2
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO BID

    Reporting group title
    BMS-986165 3 mg
    Reporting group description
    		 BMS-986165 3 mg PO BID

    Reporting group title
    BMS-986165 6 mg
    Reporting group description
    		 BMS-986165 6 mg PO BID

    Reporting group title
    BMS-986165 12 mg
    Reporting group description
    		 BMS-986165 12 mg PO QD

    Reporting group values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg Total
    Number of subjects
    		 90 91 93 89 363
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.1 ± 13.1 40.2 ± 11.9 40.9 ± 12.5 39.0 ± 10.6 -
    Sex: Female, Male
    Units: Participants
        Female
    		 80 85 88 81 334
        Male
    		 10 6 5 8 29
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 4 3 5 2 14
        Asian
    		 10 9 15 10 44
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 6 10 8 9 33
        White
    		 60 62 55 57 234
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 10 7 10 11 38
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 31 31 29 36 127
        Not Hispanic or Latino
    		 58 60 64 53 235
        Unknown or Not Reported
    		 1 0 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO BID

    Reporting group title
    BMS-986165 3 mg
    Reporting group description
    		 BMS-986165 3 mg PO BID

    Reporting group title
    BMS-986165 6 mg
    Reporting group description
    		 BMS-986165 6 mg PO BID

    Reporting group title
    BMS-986165 12 mg
    Reporting group description
    		 BMS-986165 12 mg PO QD

    Primary: Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32

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    End point title
    		 Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
    End point description
    SRI(4) responder is defined as a patient whose disease course fulfills all of the following: (1) A 4-point or greater reduction from baseline in SLEDAI-2K score (2) No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade (3) No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
    End point type
    Primary
    End point timeframe
    At week 32
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Participants
    31
    53
    46
    40
    Statistical analysis title
    		 Odds Ratio BMS-986165 3 mg vs Placebo
    Statistical analysis description
    BMS-986165 3 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 3 mg
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0006
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 5.1
    Statistical analysis title
    		 Odds Ratio BMS-986165 12 mg vs Placebo
    Statistical analysis description
    BMS-986165 12 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0781
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 2.9
    Statistical analysis title
    		 Odds Ratio BMS-986165 6 mg vs Placebo
    Statistical analysis description
    BMS-986165 6 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 6 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.021
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 3.4

    Secondary: Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48

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    End point title
    		 Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
    End point description
    SRI(4) responder is defined as a patient whose disease course fulfills all of the following: (1) A 4-point or greater reduction from baseline in SLEDAI-2K score (2) No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade (3) No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
    End point type
    Secondary
    End point timeframe
    At week 48
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Participants
    31
    52
    44
    42
    Statistical analysis title
    		 Odds Ratio BMS-986165 3 mg vs Placebo
    Statistical analysis description
    BMS-986165 3 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 3 mg
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0011
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 4.8
    Statistical analysis title
    		 Odds Ratio BMS-986165 6 mg vs Placebo
    Statistical analysis description
    BMS-986165 6 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 6 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0434
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 3.1
    Statistical analysis title
    		 Odds Ratio BMS-986165 12 mg vs Placebo
    Statistical analysis description
    BMS-986165 12 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0439
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 3.1

    Secondary: Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response

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    End point title
    		 Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
    End point description
    BICLA responder is defined as a patient whose disease course fulfills all of the following: (1) Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline (2) No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B (3) No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score) (4) No increase ≥ 10% in the Physician’s Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity (5) No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment
    End point type
    Secondary
    End point timeframe
    At week 48
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Participants
    23
    43
    33
    32
    Statistical analysis title
    		 Odds Ratio BMS-986165 3 mg vs Placebo
    Statistical analysis description
    BMS-986165 3 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 3 mg
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0012
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 5.1
    Statistical analysis title
    		 Odds Ratio BMS-986165 12 mg vs Placebo
    Statistical analysis description
    BMS-986165 12 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0673
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 3.2
    Statistical analysis title
    		 Odds Ratio BMS-986165 6 mg vs Placebo
    Statistical analysis description
    BMS-986165 6 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 6 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0795
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 3

    Secondary: Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)

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    End point title
    		 Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
    End point description
    LLDAS is defined as follows: (1) SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System (2) No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters (3) Physician’s Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity (4) A current prednisolone (or equivalent) dose ≤ 7.5 mg daily (5) Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents
    End point type
    Secondary
    End point timeframe
    At Week 48
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Participants
    12
    33
    22
    23
    Statistical analysis title
    		 Odds Ratio BMS-986165 3 mg vs Placebo
    Statistical analysis description
    BMS-986165 3 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 3 mg
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0002
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9
         upper limit
    		 8.5
    Statistical analysis title
    		 Odds Ratio BMS-986165 12 mg vs Placebo
    Statistical analysis description
    BMS-986165 12 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0168
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 5.1
    Statistical analysis title
    		 Odds Ratio BMS-986165 6 mg vs Placebo
    Statistical analysis description
    BMS-986165 6 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 6 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0371
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 4.5

    Secondary: Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10

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    End point title
    		 Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10
    End point description
    Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia
    End point type
    Secondary
    End point timeframe
    At week 48
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    24
    23
    25
    29
    Units: Participants
    4
    16
    14
    18
    Statistical analysis title
    		 Odds Ratio BMS-986165 3 mg vs Placebo
    Statistical analysis description
    BMS-986165 3 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 3 mg
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0006
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 43
    Statistical analysis title
    		 Odds Ratio BMS-986165 12 mg vs Placebo
    Statistical analysis description
    BMS-986165 12 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0009
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 31
    Statistical analysis title
    		 Odds Ratio BMS-986165 6 mg vs Placebo
    Statistical analysis description
    BMS-986165 6 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 6 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0058
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 22

    Secondary: Change from Baseline in the 40-Joint Count

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    End point title
    		 Change from Baseline in the 40-Joint Count
    End point description
    Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of: (1) Tender joint count (0 to 40) (2) Swollen joint count (0 to 40) (3) Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.
    End point type
    Secondary
    End point timeframe
    Baseline and week 48
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Tender
    -11.2 ± 8.0
    -12.2 ± 7.5
    -11.7 ± 9.5
    -12.3 ± 7.1
        Swollen
    -8.3 ± 6.9
    -8.5 ± 4.2
    -8.8 ± 7.2
    -9.9 ± 6.1
        Tender + Swollen
    -8.2 ± 6.7
    -8.2 ± 4.3
    -8.5 ± 7.0
    -9.7 ± 5.9
    Statistical analysis title
    		 Odd Ratio Tender BMS-986165 3 mg vs Placebo
    Statistical analysis description
    Tender BMS-986165 3 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 3 mg
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0131
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.04
    Statistical analysis title
    		 Odd Ratio Tender BMS-986165 6 mg vs Placebo
    Statistical analysis description
    Tender BMS-986165 6 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 6 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4156
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.04
    Statistical analysis title
    		 Odd Ratio Tender BMS-986165 12 mg vs Placebo
    Statistical analysis description
    Tender BMS-986165 12 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0151
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.09
    Statistical analysis title
    		 Odd Ratio Swollen BMS-986165 3 mg vs Placebo
    Statistical analysis description
    Swollen BMS-986165 3 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 3 mg
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0029
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.45
    Statistical analysis title
    		 Odd Ratio Swollen BMS-986165 6 mg vs Placebo
    Statistical analysis description
    Swollen BMS-986165 6 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 6 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0516
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.46
    Statistical analysis title
    		 OR Tender + Swollen BMS-986165 3 mg vs Placebo
    Statistical analysis description
    Tender + Swollen BMS-986165 3 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 3 mg
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.001
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 -0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Statistical analysis title
    		 Odd Ratio Swollen BMS-986165 12 mg vs Placebo
    Statistical analysis description
    Swollen BMS-986165 12 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0298
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.48
    Statistical analysis title
    		 OR Tender + Swollen BMS-986165 6 mg vs Placebo
    Statistical analysis description
    Tender + Swollen BMS-986165 6 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 6 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0343
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Statistical analysis title
    		 OR Tender + Swollen BMS-986165 12 mg vs Placebo
    Statistical analysis description
    Tender + Swollen BMS-986165 12 mg vs Placebo
    Comparison groups
    Placebo v BMS-986165 12 mg
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.005
    Method
    		 Longitudinal Repeated Measures
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.42

    Secondary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment
    End point type
    Secondary
    End point timeframe
    From first dose to 30 days post last dose (Up to 52 weeks)
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Participants
        AEs
    79
    85
    81
    75
        SAEs
    11
    7
    8
    7
    No statistical analyses for this end point

    Secondary: Number of Participants with Laboratory Abnormalities in Specific Liver Tests

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    End point title
    		 Number of Participants with Laboratory Abnormalities in Specific Liver Tests
    End point description
    Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following: (1) Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN) (2) Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase) (3) No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic
    End point type
    Secondary
    End point timeframe
    From first dose to 30 days post last dose (Up to 52 weeks)
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Participants
        ALT or AST > 3XULN
    2
    5
    3
    2
        ALT or AST > 5XULN
    2
    1
    1
    1
        Total Bilirubin > 2XULN
    0
    0
    0
    0
        ALT or AST>3XULN and Total Bilirubin>2XULN
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormalities in Vital Signs

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    End point title
    		 Number of Participants with Abnormalities in Vital Signs
    End point description
    Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure
    End point type
    Secondary
    End point timeframe
    From first dose to 30 days post last dose (Up to 52 weeks)
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    88
    91
    87
    Units: Participants
        Wk 2: HR: Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 2: HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 2 SBP: Value>140 and change from baseline>20
    1
    1
    0
    1
        Wk 2 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 2 DBP: Value>90 and change from baseline>10
    0
    0
    1
    1
        Wk 2 DBP: Value<55 and change from baseline<-10
    0
    2
    1
    0
        Wk 4 HR: Value>100 and change from baseline>30
    0
    0
    1
    0
        Wk 4 HR: Value<55 and change from baseline<-15
    0
    1
    0
    0
        Wk 4 SBP: Value>140 and change from baseline>20
    0
    0
    0
    1
        Wk 4 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 4 DBP: Value>90 and change from baseline>10
    2
    0
    0
    1
        Wk 4 DBP: Value<55 and change from baseline<-10
    0
    0
    0
    0
        Wk 8 HR: Value>100 and change from baseline>30
    1
    2
    0
    0
        Wk 8 HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 8 SBP: Value>140 and change from baseline>20
    1
    1
    1
    0
        Wk 8 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 8 DBP: Value>90 and change from baseline>10
    0
    1
    3
    1
        Wk 8 DBP: Value<55 and change from baseline<-10
    0
    1
    0
    0
        Wk 12 HR: Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 12 HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 12 SBP: Value>140 and change from baseline>20
    1
    1
    0
    0
        Wk 12 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 12 DBP: Value>90 and change from baseline>10
    0
    3
    2
    1
        Wk 12 DBP: Value<55 and change from baseline<-10
    1
    1
    1
    0
        Wk 16 HR: Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 16 HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 16 SBP: Value>140 and change from baseline>20
    0
    0
    0
    1
        Wk 16 SBP: Value<90 and change from baseline<-20
    1
    0
    0
    0
        Wk 16 DBP: Value>90 and change from baseline>10
    0
    1
    0
    2
        Wk 16 DBP: Value<55 and change from baseline<-10
    0
    0
    0
    0
        Wk 20: HR: Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 20 HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 20 SBP: Value>140 and change from baseline>20
    1
    1
    0
    1
        Wk 20 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 20 DBP: Value>90 and change from baseline>10
    2
    2
    0
    2
        Wk 20 DBP: Value<55 and change from baseline<-10
    0
    0
    0
    0
        Wk 24 HR: Value>100 and change from baseline>30
    1
    0
    0
    0
        Wk 24 HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 24 SBP: Value>140 and change from baseline>20
    0
    1
    0
    1
        Wk 24 SBP: Value<90 and change from baseline<-20
    0
    1
    0
    0
        Wk 24 DBP: Value>90 and change from baseline>10
    0
    1
    0
    2
        Wk 24 DBP: Value<55 and change from baseline<-10
    0
    1
    0
    0
        Wk 28 HR Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 28 HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 28 SBP: Value>140 and change from baseline>20
    1
    3
    1
    3
        Wk 28 SBP: Value<90 and change from baseline<-20
    0
    0
    1
    0
        Wk 28 DBP: Value>90 and change from baseline>10
    1
    4
    0
    2
        Wk 28 DBP: Value<55 and change from baseline<-10
    0
    1
    0
    0
        Wk 32 HR: Value>100 and change from baseline>30
    0
    2
    1
    0
        Wk 32 HR Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 32 SBP: Value>140 and change from baseline>20
    1
    1
    0
    3
        Wk 32 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 32 DBP: Value>90 and change from baseline>10
    1
    1
    2
    3
        Wk 32 DBP: Value<55 and change from baseline<-10
    0
    1
    0
    0
        Wk 36 HR: Value>100 and change from baseline>30
    0
    1
    0
    0
        Wk 36 HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 36 SBP: Value>140 and change from baseline>20
    0
    0
    0
    1
        Wk 36 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 36 DBP: Value>90 and change from baseline>10
    1
    1
    1
    2
        Wk 36 DBP: Value<55 and change from baseline<-10
    0
    0
    0
    0
        Wk 40 HR: Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 40 HR: Value<55 and change from baseline<-15
    1
    0
    0
    0
        Wk 40 SBP: Value>140 and change from baseline>20
    1
    0
    0
    2
        Wk 40 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 40 DBP: Value>90 and change from baseline>10
    0
    2
    1
    1
        Wk 40 DBP: Value<55 and change from baseline<-10
    0
    0
    0
    0
        Wk 44 HR: Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 44 HR: Value<55 and change from baseline<-15
    0
    0
    1
    0
        Wk 44 SBP: Value>140 and change from baseline>20
    0
    0
    0
    0
        Wk 44 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 44 DBP: Value>90 and change from baseline>10
    0
    0
    1
    2
        Wk 44 DBP: Value<55 and change from baseline<-10
    1
    1
    0
    0
        Wk 48 HR: Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 48 HR: Value<55 and change from baseline<-15
    0
    0
    0
    0
        Wk 48 SBP: Value>140 and change from baseline>20
    2
    0
    0
    0
        Wk 48: SBP: Value<90 and change from baseline<-20
    0
    1
    0
    0
        Wk 48 DBP: Value>90 and change from baseline>10
    2
    1
    0
    0
        Wk 48 DBP: Value<55 and change from baseline<-10
    0
    0
    0
    0
        Wk 52 HR: Value>100 and change from baseline>30
    0
    0
    0
    0
        Wk 52 HR: Value<55 and change from baseline<-15
    0
    1
    0
    0
        Wk 52 SBP: Value>140 and change from baseline>20
    0
    0
    0
    0
        Wk 52 SBP: Value<90 and change from baseline<-20
    0
    0
    0
    0
        Wk 52 DBP: Value>90 and change from baseline>10
    0
    0
    0
    1
        Wk 52 DBP: Value<55 and change from baseline<-10
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormalities in Electrocardiograms (ECGs)

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    End point title
    		 Number of Participants with Abnormalities in Electrocardiograms (ECGs)
    End point description
    Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval
    End point type
    Secondary
    End point timeframe
    From baseline to up to week 48
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    89
    90
    92
    89
    Units: Participants
        Baseline: QTcF 450 to < 480
    9
    3
    6
    5
        Baseline: QTcF 480 to < 500
    1
    1
    0
    0
        Baseline: QTcF >= 500
    0
    0
    1
    0
        Baseline: PR Interval >= 200
    5
    4
    6
    6
        Baseline: QRS Interval >=200
    0
    0
    0
    0
        Week 4: QTcF 450 to < 480
    5
    6
    5
    6
        Week 4: QTcF 480 to < 500
    0
    2
    1
    0
        Week4: QTcF >= 500
    0
    0
    0
    1
        Week 4: PR Interval >= 200
    7
    7
    4
    5
        Week 4: QRS Interval: >= 200
    0
    0
    0
    0
        Week 8: QTcF 450 to < 480
    7
    5
    6
    1
        Week 8: QTcF 480 to < 500
    0
    0
    1
    2
        Week 8: QTcF >=500
    0
    0
    0
    0
        Week 8: PR Interval >= 200
    5
    6
    5
    6
        Week 8 QRS Interval >=200
    0
    0
    0
    0
        Week 12: QTcF 450 to < 480
    3
    4
    6
    8
        Week 12: QTcF 480 to < 500
    0
    0
    0
    0
        Week 12: QTcF >= 500
    0
    0
    0
    1
        Week 12: PR Interval >= 200
    6
    8
    4
    4
        Week 12: QRS Interval >=200
    0
    0
    0
    0
        Week 32: QTcF 450 to < 480
    5
    5
    2
    5
        Week 32: QTcF 480 to < 500
    0
    0
    2
    0
        Week 32: QTcF >=500
    0
    0
    0
    0
        Week 32: PR Interval >= 200
    5
    7
    5
    5
        Week 32: QRS Interval >= 200
    0
    0
    0
    0
        Week 48: QTcF: 450 to < 480
    7
    2
    8
    5
        Week 48: QTcF 480 to < 500
    0
    0
    0
    0
        Week 48: QTcF >=500
    0
    0
    0
    0
        Week 48: PR Interval: >= 200
    4
    7
    6
    3
        Week 48: QRS Interval: >= 200
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: BMS-986165 and its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)

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    End point title
    		 BMS-986165 and its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax) [1]
    End point description
    Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 2, 4, and 6 hours post dose on 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: Only pre-specified arms planned for this endpoint
    End point values
    		 BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    73
    73
    47
    Units: NG/ML
    geometric mean (geometric coefficient of variation)
        BMS-986165
    38.033 ± 57.72
    76.400 ± 37.72
    96.249 ± 46.80
        Metabolite BMT-153261
    6.358 ± 67.77
    12.133 ± 37.72
    11.748 ± 67.17
    No statistical analyses for this end point

    Secondary: BMS-986165 and its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)

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    End point title
    		 BMS-986165 and its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax) [2]
    End point description
    Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
    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 endpoint
    End point values
    		 BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    73
    73
    47
    Units: Hours
    median (full range (min-max))
        BMS-986165
    2.0000 (0.467 to 6.000)
    2.0000 (0.500 to 7.533)
    2.0000 (0.500 to 5.100)
        Metabolite BMT-153261
    4.0000 (0.550 to 7.500)
    4.0000 (1.017 to 9.533)
    3.7330 (0.500 to 6.067)
    No statistical analyses for this end point

    Secondary: BMS-986165 and its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)

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    End point title
    		 BMS-986165 and its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) [3]
    End point description
    Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
    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 endpoint
    End point values
    		 BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    46
    52
    64
    Units: NG/ML
    geometric mean (geometric coefficient of variation)
        BMS-986165 week 2
    14.3737 ± 60.790
    29.2909 ± 47.588
    30.8135 ± 70.340
        BMS-986165 week 4
    14.6095 ± 53.234
    22.9170 ± 51.043
    20.1182 ± 81.084
        BMS-986165 week 8
    13.0328 ± 69.792
    12.9587 ± 64.799
    26.7961 ± 67.090
        BMS-986165 week 12
    10.7517 ± 93.540
    28.7751 ± 47.282
    22.1237 ± 85.920
        BMS-986165 week 24
    10.2546 ± 66.763
    13.9273 ± 67.922
    21.8720 ± 78.559
        BMS-986165 week 32
    8.5293 ± 60.425
    15.5285 ± 61.704
    24.5060 ± 75.647
        BMS-986165 week 48
    6.8493 ± 70.206
    21.7890 ± 53.718
    15.9576 ± 102.367
        Metabolite BMT-153261 week 2
    4.2667 ± 48.679
    8.4841 ± 54.717
    8.7920 ± 61.993
        Metabolite BMT-153261 week 4
    5.0886 ± 56.764
    7.7803 ± 53.563
    7.2703 ± 70.461
        Metabolite BMT-153261 week 8
    4.1293 ± 62.816
    5.2290 ± 71.924
    8.1451 ± 57.216
        Metabolite BMT-153261 week 12
    3.7325 ± 96.323
    9.3281 ± 54.823
    7.4071 ± 82.009
        Metabolite BMT-153261 week 24
    3.3669 ± 56.381
    5.2229 ± 71.104
    6.6608 ± 63.748
        Metabolite BMT-153261 week 32
    2.9759 ± 55.379
    5.2925 ± 63.200
    6.8734 ± 77.329
        Metabolite BMT-153261 week 48
    2.8708 ± 73.450
    6.8838 ± 58.302
    5.8602 ± 75.536
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Interferon-Regulated Gene (IRG) Expression Levels

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    End point title
    		 Percent Change from Baseline in Interferon-Regulated Gene (IRG) Expression Levels
    End point description
    Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
    End point type
    Secondary
    End point timeframe
    From baseline to week 44
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Percent Change from Baseline
    arithmetic mean (standard deviation)
        IFN High
    -0.8130 ± 6.5323
    -39.7478 ± 13.0087
    -55.5691 ± 21.5313
    -47.5561 ± 12.2125
        IFN Low
    4.7381 ± 8.8696
    -18.0641 ± 27.0491
    -36.4510 ± 22.4759
    -41.7645 ± 26.1519
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32

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    End point title
    		 Percent Change from Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
    End point description
    Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
    End point type
    Secondary
    End point timeframe
    From baseline to week 32
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Percent Change from Baseline
    arithmetic mean (standard deviation)
        IFN High
    -4.3993 ± 5.2234
    -40.7944 ± 13.5929
    -54.6988 ± 16.7734
    -61.0515 ± 13.8367
        IFN Low
    -2.6555 ± 9.2649
    -27.4897 ± 20.0078
    -42.8107 ± 19.7669
    -42.9701 ± 23.8323
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Complement Proteins C3 and C4 Levels

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    End point title
    		 Percent Change from Baseline in Complement Proteins C3 and C4 Levels
    End point description
    Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
    End point type
    Secondary
    End point timeframe
    From baseline to week 52
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    8
    10
    12
    14
    Units: mg/L
    arithmetic mean (standard error)
        C3
    3.57 ± 12.225
    5.33 ± 6.216
    7.60 ± 5.315
    14.74 ± 9.619
        C4
    84.52 ± 88.618
    3.57 ± 7.146
    24.96 ± 20.508
    20.43 ± 12.767
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Complement (C3, C4) Levels at Week 32

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    End point title
    		 Percent Change from Baseline in Complement (C3, C4) Levels at Week 32
    End point description
    Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
    End point type
    Secondary
    End point timeframe
    From baseline to week 32
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    66
    75
    78
    63
    Units: mg/L
    arithmetic mean (standard error)
        C3
    -0.58 ± 3.038
    5.78 ± 3.161
    12.42 ± 2.748
    10.84 ± 2.896
        C4
    -3.27 ± 3.297
    12.32 ± 4.455
    16.71 ± 5.012
    25.13 ± 6.988
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Anti-Double-Stranded DNA (dsDNA) Antibodies Levels

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    End point title
    		 Percent Change from Baseline in Anti-Double-Stranded DNA (dsDNA) Antibodies Levels
    End point description
    Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
    End point type
    Secondary
    End point timeframe
    From baseline to week 52
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    8
    10
    12
    14
    Units: U/mL
        arithmetic mean (standard error)
    276.26 ± 316.713
    16.51 ± 28.265
    -31.79 ± 10.209
    -19.32 ± 8.722
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Anti-Double-Stranded DNA (dsDNA) Levels Antibodies at Week 32

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    End point title
    		 Percent Change from Baseline in Anti-Double-Stranded DNA (dsDNA) Levels Antibodies at Week 32
    End point description
    Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
    End point type
    Secondary
    End point timeframe
    From baseline to week 32
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    64
    75
    77
    63
    Units: U/mL
        arithmetic mean (standard error)
    21.36 ± 15.135
    -15.24 ± 4.910
    -11.31 ± 6.323
    -24.17 ± 4.781
    No statistical analyses for this end point

    Secondary: Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status

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    End point title
    		 Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
    End point description
    Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following: (1) A 4-point or greater reduction from baseline in SLEDAI-2K score (2) No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade (3) No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
    End point type
    Secondary
    End point timeframe
    At week 32
    End point values
    		 Placebo BMS-986165 3 mg BMS-986165 6 mg BMS-986165 12 mg
    Number of subjects analysed
    90
    91
    93
    89
    Units: Participants
        IFN Low
    10
    7
    11
    5
        IFN High
    21
    46
    35
    35
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Subjects were assessed for Deaths (all causes) from date of randomization to study completion (Up to 49 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO BID

    Reporting group title
    BMS-986165 3 mg BID
    Reporting group description
    		 BMS-986165 3 mg PO BID

    Reporting group title
    BMS-986165 6 mg BID
    Reporting group description
    		 BMS-986165 6 mg PO BID

    Reporting group title
    BMS-986165 12 mg QD
    Reporting group description
    		 BMS-986165 12 mg PO QD

    Serious adverse events
    		 Placebo BMS-986165 3 mg BID BMS-986165 6 mg BID BMS-986165 12 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 90 (12.22%)
    7 / 91 (7.69%)
    8 / 93 (8.60%)
    7 / 89 (7.87%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the vagina
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous incomplete
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    General disorders and administration site conditions
    Generalised oedema
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    Oedema peripheral
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dysarthria
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    Epilepsy
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    Hemiparesis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    Optic neuritis
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 89 (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
    Seizure
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord disorder
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deficiency anaemia
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Scleritis
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    Pancreatitis acute
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 91 (1.10%)
    1 / 93 (1.08%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    Toxic skin eruption
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    2 / 90 (2.22%)
    0 / 91 (0.00%)
    2 / 93 (2.15%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 89 (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
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 89 (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
    Herpes zoster
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
    0 / 89 (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
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 90 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo BMS-986165 3 mg BID BMS-986165 6 mg BID BMS-986165 12 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    79 / 90 (87.78%)
    85 / 91 (93.41%)
    81 / 93 (87.10%)
    73 / 89 (82.02%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 90 (3.33%)
    4 / 91 (4.40%)
    3 / 93 (3.23%)
    6 / 89 (6.74%)
         occurrences all number
    3
    4
    3
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 90 (16.67%)
    7 / 91 (7.69%)
    8 / 93 (8.60%)
    11 / 89 (12.36%)
         occurrences all number
    20
    8
    9
    19
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 90 (5.56%)
    4 / 91 (4.40%)
    8 / 93 (8.60%)
    3 / 89 (3.37%)
         occurrences all number
    6
    4
    8
    4
    Nausea
         subjects affected / exposed
    8 / 90 (8.89%)
    6 / 91 (6.59%)
    5 / 93 (5.38%)
    4 / 89 (4.49%)
         occurrences all number
    8
    8
    6
    4
    Vomiting
         subjects affected / exposed
    6 / 90 (6.67%)
    3 / 91 (3.30%)
    4 / 93 (4.30%)
    1 / 89 (1.12%)
         occurrences all number
    6
    3
    6
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    5 / 90 (5.56%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    5
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    4 / 90 (4.44%)
    3 / 91 (3.30%)
    8 / 93 (8.60%)
    7 / 89 (7.87%)
         occurrences all number
    4
    3
    8
    9
    Rash
         subjects affected / exposed
    0 / 90 (0.00%)
    2 / 91 (2.20%)
    3 / 93 (3.23%)
    7 / 89 (7.87%)
         occurrences all number
    0
    3
    3
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 90 (1.11%)
    5 / 91 (5.49%)
    1 / 93 (1.08%)
    0 / 89 (0.00%)
         occurrences all number
    1
    5
    1
    0
    Back pain
         subjects affected / exposed
    6 / 90 (6.67%)
    1 / 91 (1.10%)
    8 / 93 (8.60%)
    2 / 89 (2.25%)
         occurrences all number
    6
    1
    8
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    6 / 90 (6.67%)
    3 / 91 (3.30%)
    5 / 93 (5.38%)
    0 / 89 (0.00%)
         occurrences all number
    6
    3
    5
    0
    Cystitis
         subjects affected / exposed
    0 / 90 (0.00%)
    5 / 91 (5.49%)
    1 / 93 (1.08%)
    2 / 89 (2.25%)
         occurrences all number
    0
    9
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    11 / 90 (12.22%)
    8 / 91 (8.79%)
    13 / 93 (13.98%)
    8 / 89 (8.99%)
         occurrences all number
    21
    11
    19
    8
    Oral herpes
         subjects affected / exposed
    0 / 90 (0.00%)
    4 / 91 (4.40%)
    4 / 93 (4.30%)
    5 / 89 (5.62%)
         occurrences all number
    0
    7
    8
    5
    Pharyngitis
         subjects affected / exposed
    2 / 90 (2.22%)
    7 / 91 (7.69%)
    5 / 93 (5.38%)
    2 / 89 (2.25%)
         occurrences all number
    2
    8
    8
    3
    Sinusitis
         subjects affected / exposed
    2 / 90 (2.22%)
    4 / 91 (4.40%)
    5 / 93 (5.38%)
    0 / 89 (0.00%)
         occurrences all number
    2
    4
    5
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 90 (3.33%)
    10 / 91 (10.99%)
    6 / 93 (6.45%)
    6 / 89 (6.74%)
         occurrences all number
    3
    13
    9
    7
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 90 (8.89%)
    13 / 91 (14.29%)
    18 / 93 (19.35%)
    8 / 89 (8.99%)
         occurrences all number
    13
    17
    21
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jan 2018
    Updated endpoints, treatment frequency, and inclusion/exclusion criteria
    28 Jan 2019
    Updated endpoints and inclusion/exclusion criteria
    11 Jun 2019
    Updated endpoints and clarified inclusion criteria
    15 Apr 2020
    Updated contact information and endpoints

    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
    For support, Contact us.
    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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