Trial Outcomes & Findings for An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus (NCT NCT03252587)

NCT ID: NCT03252587

Last Updated: 2022-12-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 363 participants
• Primary outcome timeframe: At week 32
• Results posted on: 2022-12-20

Participant Flow

Participant milestones

Measure	Placebo Placebo PO BID	BMS-986165 3 mg BMS-986165 3 mg PO BID	BMS-986165 6 mg BMS-986165 6 mg PO BID	BMS-986165 12 mg BMS-986165 12 mg PO QD
Overall Study STARTED	90	91	93	89
Overall Study COMPLETED	66	71	76	62
Overall Study NOT COMPLETED	24	20	17	27

Reasons for withdrawal

Measure	Placebo Placebo PO BID	BMS-986165 3 mg BMS-986165 3 mg PO BID	BMS-986165 6 mg BMS-986165 6 mg PO BID	BMS-986165 12 mg BMS-986165 12 mg PO QD
Overall Study Adverse Event	3	8	6	12
Overall Study Lack of Efficacy	7	2	2	4
Overall Study Lost to Follow-up	2	0	0	2
Overall Study Pregnancy	2	1	0	1
Overall Study Withdrawal by Subject	8	4	4	4
Overall Study Other Reasons	2	5	5	4

Baseline Characteristics

An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

Baseline characteristics by cohort

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD	Total n=363 Participants Total of all reporting groups
Age, Continuous	40.1 Years STANDARD_DEVIATION 13.1 • n=5 Participants	40.2 Years STANDARD_DEVIATION 11.9 • n=7 Participants	40.9 Years STANDARD_DEVIATION 12.5 • n=5 Participants	39.0 Years STANDARD_DEVIATION 10.6 • n=4 Participants	40.1 Years STANDARD_DEVIATION 12.0 • n=21 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	85 Participants n=7 Participants	88 Participants n=5 Participants	81 Participants n=4 Participants	334 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	29 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=5 Participants	31 Participants n=7 Participants	29 Participants n=5 Participants	36 Participants n=4 Participants	127 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=5 Participants	60 Participants n=7 Participants	64 Participants n=5 Participants	53 Participants n=4 Participants	235 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	10 Participants n=4 Participants	44 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	33 Participants n=21 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	62 Participants n=7 Participants	55 Participants n=5 Participants	57 Participants n=4 Participants	234 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	38 Participants n=21 Participants

PRIMARY outcome

Timeframe: At week 32

Population: All Randomized Participants

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

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32	31 Participants	53 Participants	46 Participants	40 Participants

SECONDARY outcome

Timeframe: At week 48

Population: All Randomized Participants

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

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48	31 Participants	52 Participants	44 Participants	42 Participants

SECONDARY outcome

Timeframe: At week 48

Population: All Randomized Participants

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

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response	23 Participants	43 Participants	33 Participants	32 Participants

SECONDARY outcome

Timeframe: At Week 48

Population: All Randomized Participants

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

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)	12 Participants	33 Participants	22 Participants	23 Participants

SECONDARY outcome

Timeframe: At week 48

Population: All Randomized Participants with Baseline CLASI Activity Score ≥ 10

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

Outcome measures

Measure	Placebo n=24 Participants Placebo PO BID	BMS-986165 3 mg n=23 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=25 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=29 Participants BMS-986165 12 mg PO QD
Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10	4 Participants	16 Participants	14 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline and week 48

Population: All Randomized Participants

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.

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Change From Baseline in the 40-Joint Count Tender	-11.2 Units on a scale Standard Deviation 8.0	-12.2 Units on a scale Standard Deviation 7.5	-11.7 Units on a scale Standard Deviation 9.5	-12.3 Units on a scale Standard Deviation 7.1
Change From Baseline in the 40-Joint Count Swollen	-8.3 Units on a scale Standard Deviation 6.9	-8.5 Units on a scale Standard Deviation 4.2	-8.8 Units on a scale Standard Deviation 7.2	-9.9 Units on a scale Standard Deviation 6.1
Change From Baseline in the 40-Joint Count Tender + Swollen	-8.2 Units on a scale Standard Deviation 6.7	-8.2 Units on a scale Standard Deviation 4.3	-8.5 Units on a scale Standard Deviation 7.0	-9.7 Units on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 52 weeks)

Population: All treated participants

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

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	79 Participants	85 Participants	81 Participants	75 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	11 Participants	7 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 52 weeks)

Population: All treated participants with evaluable measurements

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

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Number of Participants With Laboratory Abnormalities in Specific Liver Tests ALT or AST > 3XULN	2 Participants	5 Participants	3 Participants	2 Participants
Number of Participants With Laboratory Abnormalities in Specific Liver Tests ALT or AST > 5XULN	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Specific Liver Tests Total Bilirubin > 2XULN	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Specific Liver Tests ALT or AST > 3XULN and Total Bilirubin > 2XULN on the same day	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days post last dose (Up to 52 weeks)

Population: All treated participants with evaluable measurements

Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=88 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=91 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=87 Participants BMS-986165 12 mg PO QD
Number of Participants With Abnormalities in Vital Signs Week 40: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 44: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 44: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 44: Systolic Blood Pressure: Value > 140 and change from baseline > 20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 44: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 44: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormalities in Vital Signs Week 44: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 48: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 48: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 48: Systolic Blood Pressure: Value > 140 and change from baseline > 20	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 48: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 48: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 48: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 52: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 52: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 52: Systolic Blood Pressure: Value > 140 and change from baseline > 20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 52: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 52: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 52: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 12: Systolic Blood Pressure: Value > 140 and change from baseline > 20	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 12: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 12: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	0 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 12: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 16: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 16: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 16: Systolic Blood Pressure: Value > 140 and change from baseline > 20	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 16: Systolic Blood Pressure: Value < 90 and change from baseline < -20	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 16: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormalities in Vital Signs Week 16: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 20: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 20: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 20: Systolic Blood Pressure: Value > 140 and change from baseline > 20	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 20: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 20: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	2 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Abnormalities in Vital Signs Week 20: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 24: Heart Rate: Value > 100 and change from baseline > 30	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 24: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 24: Systolic Blood Pressure: Value > 140 and change from baseline > 20	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 24: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 24: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormalities in Vital Signs Week 24: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 28: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 28: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 28: Systolic Blood Pressure: Value > 140 and change from baseline > 20	1 Participants	3 Participants	1 Participants	3 Participants
Number of Participants With Abnormalities in Vital Signs Week 28: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 28: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	1 Participants	4 Participants	0 Participants	2 Participants
Number of Participants With Abnormalities in Vital Signs Week 28: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 32: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 32: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 32: Systolic Blood Pressure: Value > 140 and change from baseline > 20	1 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Abnormalities in Vital Signs Week 32: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 32: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	1 Participants	1 Participants	2 Participants	3 Participants
Number of Participants With Abnormalities in Vital Signs Week 32: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 36: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 36: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 36: Systolic Blood Pressure: Value > 140 and change from baseline > 20	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 36: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 36: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Abnormalities in Vital Signs Week 36: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 40: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 40: Heart Rate: Value < 55 and change from baseline < -15	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 40: Systolic Blood Pressure: Value > 140 and change from baseline > 20	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormalities in Vital Signs Week 40: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 40: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 2: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 2: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 2: Systolic Blood Pressure: Value > 140 and change from baseline > 20	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 2: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 2: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 2: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 4: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 4: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 4: Systolic Blood Pressure: Value > 140 and change from baseline > 20	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 4: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 4: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 4: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 8: Heart Rate: Value > 100 and change from baseline > 30	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 8: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 8: Systolic Blood Pressure: Value > 140 and change from baseline > 20	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 8: Systolic Blood Pressure: Value < 90 and change from baseline < -20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 8: Diastolic Blood Pressure: Value > 90 and change from baseline > 10	0 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Abnormalities in Vital Signs Week 8: Diastolic Blood Pressure: Value < 55 and change from baseline < -10	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 12: Heart Rate: Value > 100 and change from baseline > 30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Vital Signs Week 12: Heart Rate: Value < 55 and change from baseline < -15	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to up to week 48

Population: All treated participants with evaluable measurements

Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval

Outcome measures

Measure	Placebo n=89 Participants Placebo PO BID	BMS-986165 3 mg n=90 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=92 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 48: QTcF 480 to < 500	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Baseline: QTcF 450 to < 480	9 Participants	3 Participants	6 Participants	5 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Baseline: QTcF 480 to < 500	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Baseline: QTcF >= 500	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Baseline: PR Interval >= 200	5 Participants	4 Participants	6 Participants	6 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Baseline: QRS Interval >=200	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 4: QTcF 450 to < 480	5 Participants	6 Participants	5 Participants	6 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 4: QTcF 480 to < 500	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week4: QTcF >= 500	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 4: PR Interval >= 200	7 Participants	7 Participants	4 Participants	5 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 4: QRS Interval: >= 200	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 8: QTcF 450 to < 480	7 Participants	5 Participants	6 Participants	1 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 8: QTcF 480 to < 500	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 8: QTcF >=500	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 8: PR Interval >= 200	5 Participants	6 Participants	5 Participants	6 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 8 QRS Interval >=200	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 12: QTcF 450 to < 480	3 Participants	4 Participants	6 Participants	8 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 12: QTcF 480 to < 500	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 12: QTcF >= 500	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 12: PR Interval >= 200	6 Participants	8 Participants	4 Participants	4 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 12: QRS Interval >=200	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 32: QTcF 450 to < 480	5 Participants	5 Participants	2 Participants	5 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 32: QTcF 480 to < 500	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 32: QTcF >=500	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 32: PR Interval >= 200	5 Participants	7 Participants	5 Participants	5 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 32: QRS Interval >= 200	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 48: QTcF: 450 to < 480	7 Participants	2 Participants	8 Participants	5 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 48: QTcF >=500	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 48: PR Interval: >= 200	4 Participants	7 Participants	6 Participants	3 Participants
Number of Participants With Abnormalities in Electrocardiograms (ECGs) Week 48: QRS Interval: >= 200	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12

Population: All evaluable PK participants (all treated participants with available concentration-time data)

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.

Outcome measures

Measure	Placebo n=73 Participants Placebo PO BID	BMS-986165 3 mg n=73 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=47 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg BMS-986165 12 mg PO QD
BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax) BMS-986165	38.033 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57.72	76.400 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 37.72	96.249 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 46.80	—
BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax) Metabolite BMT-153261	6.358 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.77	12.133 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 59.50	11.748 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.17	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12

Population: All evaluable PK participants (all treated participants with available concentration-time data)

Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.

Outcome measures

Measure	Placebo n=73 Participants Placebo PO BID	BMS-986165 3 mg n=73 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=47 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg BMS-986165 12 mg PO QD
BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax) BMS-986165	2.0000 Hours Interval 0.467 to 6.0	2.0000 Hours Interval 0.5 to 7.533	2.0000 Hours Interval 0.5 to 5.1	—
BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax) Metabolite BMT-153261	4.0000 Hours Interval 0.55 to 7.5	4.0000 Hours Interval 1.017 to 9.533	3.7330 Hours Interval 0.5 to 6.067	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48

Population: All evaluable PK participants (all treated participants with available concentration-time data)

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.

Outcome measures

Measure	Placebo n=46 Participants Placebo PO BID	BMS-986165 3 mg n=52 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=64 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg BMS-986165 12 mg PO QD
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) BMS-986165 week 2	14.3737 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 60.790	29.2909 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 47.588	30.8135 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 70.340	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) BMS-986165 week 4	14.6095 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53.234	22.9170 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 51.043	20.1182 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 81.084	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) BMS-986165 week 8	13.0328 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 69.792	12.9587 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 64.799	26.7961 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.090	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) BMS-986165 week 12	10.7517 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 93.540	28.7751 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 47.282	22.1237 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 85.920	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) BMS-986165 week 24	10.2546 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 66.763	13.9273 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 67.922	21.8720 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 78.559	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) BMS-986165 week 32	8.5293 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 60.425	15.5285 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 61.704	24.5060 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75.647	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) BMS-986165 week 48	6.8493 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 70.206	21.7890 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53.718	15.9576 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 102.367	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) Metabolite BMT-153261 week 2	4.2667 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 48.679	8.4841 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54.717	8.7920 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 61.993	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) Metabolite BMT-153261 week 4	5.0886 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 56.764	7.7803 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 53.563	7.2703 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 70.461	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) Metabolite BMT-153261 week 8	4.1293 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 62.816	5.2290 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 71.924	8.1451 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57.216	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) Metabolite BMT-153261 week 12	3.7325 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 96.323	9.3281 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 54.823	7.4071 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 82.009	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) Metabolite BMT-153261 week 24	3.3669 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 56.381	5.2229 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 71.104	6.6608 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 63.748	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) Metabolite BMT-153261 week 32	2.9759 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 55.379	5.2925 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 63.200	6.8734 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 77.329	—
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough) Metabolite BMT-153261 week 48	2.8708 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 73.450	6.8838 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 58.302	5.8602 NG/ML Geometric Coefficient of Variation NA Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 75.536	—

SECONDARY outcome

Timeframe: From baseline to week 44

Population: All evaluable PD participants (all treated participants with at least one post-treatment measurement)

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.

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels IFN High	-0.8130 Percent Change from Baseline Standard Deviation 6.5323	-39.7478 Percent Change from Baseline Standard Deviation 13.0087	-55.5691 Percent Change from Baseline Standard Deviation 21.5313	-47.5561 Percent Change from Baseline Standard Deviation 12.2125
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels IFN Low	4.7381 Percent Change from Baseline Standard Deviation 8.8696	-18.0641 Percent Change from Baseline Standard Deviation 27.0491	-36.4510 Percent Change from Baseline Standard Deviation 22.4759	-41.7645 Percent Change from Baseline Standard Deviation 26.1519

SECONDARY outcome

Timeframe: From baseline to week 32

Population: All evaluable PD participants (all treated participants with at least one post-treatment measurement)

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.

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32 IFN High	-4.3993 Percent Change from Baseline Standard Deviation 5.2234	-40.7944 Percent Change from Baseline Standard Deviation 13.5929	-54.6988 Percent Change from Baseline Standard Deviation 16.7734	-61.0515 Percent Change from Baseline Standard Deviation 13.8367
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32 IFN Low	-2.6555 Percent Change from Baseline Standard Deviation 9.2649	-27.4897 Percent Change from Baseline Standard Deviation 20.0078	-42.8107 Percent Change from Baseline Standard Deviation 19.7669	-42.9701 Percent Change from Baseline Standard Deviation 23.8323

SECONDARY outcome

Timeframe: From baseline to week 52

Population: All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.

Outcome measures

Measure	Placebo n=8 Participants Placebo PO BID	BMS-986165 3 mg n=10 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=12 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=14 Participants BMS-986165 12 mg PO QD
Percent Change From Baseline in Complement Proteins C3 and C4 Levels C3	3.57 Percent Change from Baseline Standard Error 12.225	5.33 Percent Change from Baseline Standard Error 6.216	7.60 Percent Change from Baseline Standard Error 5.315	14.74 Percent Change from Baseline Standard Error 9.619
Percent Change From Baseline in Complement Proteins C3 and C4 Levels C4	84.52 Percent Change from Baseline Standard Error 88.618	3.57 Percent Change from Baseline Standard Error 7.146	24.96 Percent Change from Baseline Standard Error 20.508	20.43 Percent Change from Baseline Standard Error 12.767

SECONDARY outcome

Timeframe: From baseline to week 32

Population: All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.

Outcome measures

Measure	Placebo n=66 Participants Placebo PO BID	BMS-986165 3 mg n=75 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=78 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=63 Participants BMS-986165 12 mg PO QD
Percent Change From Baseline in Complement (C3, C4) Levels at Week 32 C3	-0.58 Percent Change from Baseline Standard Error 3.038	5.78 Percent Change from Baseline Standard Error 3.161	12.42 Percent Change from Baseline Standard Error 2.748	10.84 Percent Change from Baseline Standard Error 2.896
Percent Change From Baseline in Complement (C3, C4) Levels at Week 32 C4	-3.27 Percent Change from Baseline Standard Error 3.297	12.32 Percent Change from Baseline Standard Error 4.455	16.71 Percent Change from Baseline Standard Error 5.012	25.13 Percent Change from Baseline Standard Error 6.988

SECONDARY outcome

Timeframe: From baseline to week 52

Population: All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.

Outcome measures

Measure	Placebo n=8 Participants Placebo PO BID	BMS-986165 3 mg n=10 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=12 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=14 Participants BMS-986165 12 mg PO QD
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels	276.26 Percent Change from Baseline Standard Error 316.713	16.51 Percent Change from Baseline Standard Error 28.265	-31.79 Percent Change from Baseline Standard Error 10.209	-19.32 Percent Change from Baseline Standard Error 8.722

SECONDARY outcome

Timeframe: From baseline to week 32

Population: All evaluable PD participants (all treated participants with at least one post-treatment measurement)

Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.

Outcome measures

Measure	Placebo n=64 Participants Placebo PO BID	BMS-986165 3 mg n=75 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=77 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=63 Participants BMS-986165 12 mg PO QD
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32	21.36 Percent Change from Baseline Standard Error 15.135	-15.24 Percent Change from Baseline Standard Error 4.910	-11.31 Percent Change from Baseline Standard Error 6.323	-24.17 Percent Change from Baseline Standard Error 4.781

SECONDARY outcome

Timeframe: At week 32

Population: All randomized participants with SLE clinical response

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

Outcome measures

Measure	Placebo n=90 Participants Placebo PO BID	BMS-986165 3 mg n=91 Participants BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 Participants BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 Participants BMS-986165 12 mg PO QD
Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status IFN Low	10 Participants	7 Participants	11 Participants	5 Participants
Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status IFN High	21 Participants	46 Participants	35 Participants	35 Participants

Adverse Events

Placebo

Serious events: 11 serious events

Other events: 52 other events

Deaths: 0 deaths

BMS-986165 3 mg

Serious events: 7 serious events

Other events: 56 other events

Deaths: 0 deaths

BMS-986165 6 mg

Serious events: 8 serious events

Other events: 60 other events

Deaths: 0 deaths

BMS-986165 12 mg

Serious events: 7 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=90 participants at risk Placebo PO BID	BMS-986165 3 mg n=91 participants at risk BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 participants at risk BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 participants at risk BMS-986165 12 mg PO QD
Blood and lymphatic system disorders Anaemia	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Blood and lymphatic system disorders Deficiency anaemia	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Cardiac disorders Coronary artery disease	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Eye disorders Scleritis	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Gastrointestinal disorders Abdominal pain	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Gastrointestinal disorders Pancreatitis acute	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
General disorders Generalised oedema	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
General disorders Oedema peripheral	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Hepatobiliary disorders Bile duct stone	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Hepatobiliary disorders Hepatitis acute	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations COVID-19	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations COVID-19 pneumonia	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Herpes zoster	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Pyelonephritis chronic	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Urinary tract infection	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Injury, poisoning and procedural complications Forearm fracture	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	2.2% 2/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	2.2% 2/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the vagina	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Nervous system disorders Dysarthria	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Nervous system disorders Epilepsy	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Nervous system disorders Hemiparesis	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Nervous system disorders Optic neuritis	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Nervous system disorders Seizure	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Nervous system disorders Spinal cord disorder	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Renal and urinary disorders Nephrolithiasis	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Skin and subcutaneous tissue disorders Drug eruption	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Vascular disorders Hypertensive crisis	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)

Other adverse events

Measure	Placebo n=90 participants at risk Placebo PO BID	BMS-986165 3 mg n=91 participants at risk BMS-986165 3 mg PO BID	BMS-986165 6 mg n=93 participants at risk BMS-986165 6 mg PO BID	BMS-986165 12 mg n=89 participants at risk BMS-986165 12 mg PO QD
Gastrointestinal disorders Diarrhoea	5.6% 5/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	4.4% 4/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	8.6% 8/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	3.4% 3/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Gastrointestinal disorders Nausea	8.9% 8/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	6.6% 6/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	5.4% 5/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	4.5% 4/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Gastrointestinal disorders Vomiting	6.7% 6/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	3.3% 3/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	4.3% 4/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Bronchitis	6.7% 6/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	3.3% 3/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	5.4% 5/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Cystitis	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	5.5% 5/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	2.2% 2/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Nasopharyngitis	12.2% 11/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	8.8% 8/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	14.0% 13/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	9.0% 8/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Oral herpes	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	4.4% 4/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	4.3% 4/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	5.6% 5/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Pharyngitis	2.2% 2/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	7.7% 7/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	5.4% 5/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	2.2% 2/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Sinusitis	2.2% 2/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	4.4% 4/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	5.4% 5/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Upper respiratory tract infection	8.9% 8/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	14.3% 13/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	19.4% 18/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	9.0% 8/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Infections and infestations Urinary tract infection	3.3% 3/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	11.0% 10/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	6.5% 6/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	6.7% 6/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	5.5% 5/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Musculoskeletal and connective tissue disorders Back pain	6.7% 6/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	8.6% 8/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	2.2% 2/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Nervous system disorders Headache	16.7% 15/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	7.7% 7/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	8.6% 8/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	12.4% 11/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.6% 5/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	0.00% 0/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	1.1% 1/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Skin and subcutaneous tissue disorders Acne	4.4% 4/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	3.3% 3/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	8.6% 8/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	7.9% 7/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Skin and subcutaneous tissue disorders Rash	0.00% 0/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	2.2% 2/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	3.2% 3/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	7.9% 7/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)
Vascular disorders Hypertension	3.3% 3/90 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	4.4% 4/91 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	3.2% 3/93 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)	6.7% 6/89 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 30 days post last dose (Up to 52 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to 49 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER