A Phase 2 interventional study of BMS-986165 and Placebo in Systemic Lupus Erythematosus, sponsored by Bristol-Myers Squibb. Completed at 192 sites in 17 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply
Drug: BMS-986165
Drug: BMS-986165
Drug: BMS-986165
Other: Placebo
Specified dose on specified days
Specified dose on specified days
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
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
Time frame: At week 32
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
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
Time frame: At week 48
Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
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
Time frame: At week 48
Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
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
Time frame: At Week 48
Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group 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
Time frame: At week 48
Change From Baseline in the 40-Joint Count
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.
Time frame: Baseline and week 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Time frame: From first dose to 30 days post last dose (Up to 52 weeks)
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
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
Time frame: From first dose to 30 days post last dose (Up to 52 weeks)
Number of Participants With Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure
Time frame: From first dose to 30 days post last dose (Up to 52 weeks)
Number of Participants With Abnormalities in Electrocardiograms (ECGs)
Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval
Time frame: From baseline to up to week 48
BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)
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.
Time frame: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12
BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)
Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.
Time frame: Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)
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.
Time frame: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels
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.
Time frame: From baseline to week 44
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
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.
Time frame: From baseline to week 32
Percent Change From Baseline in Complement Proteins C3 and C4 Levels
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
Time frame: From baseline to week 52
Percent Change From Baseline in Complement (C3, C4) Levels at Week 32
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
Time frame: From baseline to week 32
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
Time frame: From baseline to week 52
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
Time frame: From baseline to week 32
Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
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
Time frame: At week 32
| Milestone | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Started | 90 | 91 | 93 | 89 |
| Completed | 66 | 71 | 76 | 62 |
| Not completed | 24 | 20 | 17 | 27 |
| Withdrew: Adverse event | 3 | 8 | 6 | 12 |
| Withdrew: Lack of efficacy | 7 | 2 | 2 | 4 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 | 2 |
| Withdrew: Pregnancy | 2 | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 8 | 4 | 4 | 4 |
| Withdrew: Other reasons | 2 | 5 | 5 | 4 |
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
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32 | 31 | 53 | 46 | 40 |
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
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48 | 31 | 52 | 44 | 42 |
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
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response | 23 | 43 | 33 | 32 |
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
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) | 12 | 33 | 22 | 23 |
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
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10 | 4 | 16 | 14 | 18 |
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.
| Units on a scale | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Tender | -11.2 ± 8.0 | -12.2 ± 7.5 | -11.7 ± 9.5 | -12.3 ± 7.1 |
| Swollen | -8.3 ± 6.9 | -8.5 ± 4.2 | -8.8 ± 7.2 | -9.9 ± 6.1 |
| Tender + Swollen | -8.2 ± 6.7 | -8.2 ± 4.3 | -8.5 ± 7.0 | -9.7 ± 5.9 |
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
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| AEs | 79 | 85 | 81 | 75 |
| SAEs | 11 | 7 | 8 | 7 |
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
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| ALT or AST > 3XULN | 2 | 5 | 3 | 2 |
| ALT or AST > 5XULN | 2 | 1 | 1 | 1 |
| Total Bilirubin > 2XULN | 0 | 0 | 0 | 0 |
| ALT or AST > 3XULN and Total Bilirubin > 2XULN on the same day | 0 | 0 | 0 | 0 |
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Week 2: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 2: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 2: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 1 | 1 | 0 | 1 |
| Week 2: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 2: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 0 | 0 | 1 | 1 |
| Week 2: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 2 | 1 | 0 |
| Week 4: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 1 | 0 |
| Week 4: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 1 | 0 | 0 |
| Week 4: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 0 | 0 | 0 | 1 |
| Week 4: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 4: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 2 | 0 | 0 | 1 |
| Week 4: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 0 | 0 | 0 |
| Week 8: Heart Rate: Value > 100 and change from baseline > 30 | 1 | 2 | 0 | 0 |
| Week 8: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 8: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 1 | 1 | 1 | 0 |
| Week 8: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 8: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 0 | 1 | 3 | 1 |
| Week 8: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 1 | 0 | 0 |
| Week 12: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 12: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 12: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 1 | 1 | 0 | 0 |
| Week 12: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 12: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 0 | 3 | 2 | 1 |
| Week 12: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 1 | 1 | 1 | 0 |
| Week 16: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 16: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 16: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 0 | 0 | 0 | 1 |
| Week 16: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 1 | 0 | 0 | 0 |
| Week 16: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 0 | 1 | 0 | 2 |
| Week 16: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 0 | 0 | 0 |
| Week 20: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 20: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 20: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 1 | 1 | 0 | 1 |
| Week 20: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 20: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 2 | 2 | 0 | 2 |
| Week 20: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 0 | 0 | 0 |
| Week 24: Heart Rate: Value > 100 and change from baseline > 30 | 1 | 0 | 0 | 0 |
| Week 24: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 24: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 0 | 1 | 0 | 1 |
| Week 24: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 1 | 0 | 0 |
| Week 24: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 0 | 1 | 0 | 2 |
| Week 24: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 1 | 0 | 0 |
| Week 28: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 28: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 28: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 1 | 3 | 1 | 3 |
| Week 28: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 1 | 0 |
| Week 28: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 1 | 4 | 0 | 2 |
| Week 28: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 1 | 0 | 0 |
| Week 32: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 2 | 1 | 0 |
| Week 32: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 32: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 1 | 1 | 0 | 3 |
| Week 32: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 32: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 1 | 1 | 2 | 3 |
| Week 32: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 1 | 0 | 0 |
| Week 36: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 1 | 0 | 0 |
| Week 36: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 36: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 0 | 0 | 0 | 1 |
| Week 36: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 36: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 1 | 1 | 1 | 2 |
| Week 36: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 0 | 0 | 0 |
| Week 40: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 40: Heart Rate: Value < 55 and change from baseline < -15 | 1 | 0 | 0 | 0 |
| Week 40: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 1 | 0 | 0 | 2 |
| Week 40: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 40: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 0 | 2 | 1 | 1 |
| Week 40: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 0 | 0 | 0 |
| Week 44: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 44: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 1 | 0 |
| Week 44: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 0 | 0 | 0 | 0 |
| Week 44: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 44: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 0 | 0 | 1 | 2 |
| Week 44: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 1 | 1 | 0 | 0 |
| Week 48: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 48: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 0 | 0 | 0 |
| Week 48: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 2 | 0 | 0 | 0 |
| Week 48: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 1 | 0 | 0 |
| Week 48: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 2 | 1 | 0 | 0 |
| Week 48: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 0 | 0 | 0 |
| Week 52: Heart Rate: Value > 100 and change from baseline > 30 | 0 | 0 | 0 | 0 |
| Week 52: Heart Rate: Value < 55 and change from baseline < -15 | 0 | 1 | 0 | 0 |
| Week 52: Systolic Blood Pressure: Value > 140 and change from baseline > 20 | 0 | 0 | 0 | 0 |
| Week 52: Systolic Blood Pressure: Value < 90 and change from baseline < -20 | 0 | 0 | 0 | 0 |
| Week 52: Diastolic Blood Pressure: Value > 90 and change from baseline > 10 | 0 | 0 | 0 | 1 |
| Week 52: Diastolic Blood Pressure: Value < 55 and change from baseline < -10 | 0 | 0 | 0 | 0 |
Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Baseline: QTcF 450 to < 480 | 9 | 3 | 6 | 5 |
| Baseline: QTcF 480 to < 500 | 1 | 1 | 0 | 0 |
| Baseline: QTcF >= 500 | 0 | 0 | 1 | 0 |
| Baseline: PR Interval >= 200 | 5 | 4 | 6 | 6 |
| Baseline: QRS Interval >=200 | 0 | 0 | 0 | 0 |
| Week 4: QTcF 450 to < 480 | 5 | 6 | 5 | 6 |
| Week 4: QTcF 480 to < 500 | 0 | 2 | 1 | 0 |
| Week4: QTcF >= 500 | 0 | 0 | 0 | 1 |
| Week 4: PR Interval >= 200 | 7 | 7 | 4 | 5 |
| Week 4: QRS Interval: >= 200 | 0 | 0 | 0 | 0 |
| Week 8: QTcF 450 to < 480 | 7 | 5 | 6 | 1 |
| Week 8: QTcF 480 to < 500 | 0 | 0 | 1 | 2 |
| Week 8: QTcF >=500 | 0 | 0 | 0 | 0 |
| Week 8: PR Interval >= 200 | 5 | 6 | 5 | 6 |
| Week 8 QRS Interval >=200 | 0 | 0 | 0 | 0 |
| Week 12: QTcF 450 to < 480 | 3 | 4 | 6 | 8 |
| Week 12: QTcF 480 to < 500 | 0 | 0 | 0 | 0 |
| Week 12: QTcF >= 500 | 0 | 0 | 0 | 1 |
| Week 12: PR Interval >= 200 | 6 | 8 | 4 | 4 |
| Week 12: QRS Interval >=200 | 0 | 0 | 0 | 0 |
| Week 32: QTcF 450 to < 480 | 5 | 5 | 2 | 5 |
| Week 32: QTcF 480 to < 500 | 0 | 0 | 2 | 0 |
| Week 32: QTcF >=500 | 0 | 0 | 0 | 0 |
| Week 32: PR Interval >= 200 | 5 | 7 | 5 | 5 |
| Week 32: QRS Interval >= 200 | 0 | 0 | 0 | 0 |
| Week 48: QTcF: 450 to < 480 | 7 | 2 | 8 | 5 |
| Week 48: QTcF 480 to < 500 | 0 | 0 | 0 | 0 |
| Week 48: QTcF >=500 | 0 | 0 | 0 | 0 |
| Week 48: PR Interval: >= 200 | 4 | 7 | 6 | 3 |
| Week 48: QRS Interval: >= 200 | 0 | 0 | 0 | 0 |
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.
| NG/ML | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|
| BMS-986165 | 38.033 ± NA | 76.400 ± NA | 96.249 ± NA |
| Metabolite BMT-153261 | 6.358 ± NA | 12.133 ± NA | 11.748 ± NA |
Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.
| Hours | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|
| BMS-986165 | 2.0000 (0.467 to 6.000) | 2.0000 (0.500 to 7.533) | 2.0000 (0.500 to 5.100) |
| Metabolite BMT-153261 | 4.0000 (0.550 to 7.500) | 4.0000 (1.017 to 9.533) | 3.7330 (0.500 to 6.067) |
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.
| NG/ML | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|
| BMS-986165 week 2 | 14.3737 ± NA | 29.2909 ± NA | 30.8135 ± NA |
| BMS-986165 week 4 | 14.6095 ± NA | 22.9170 ± NA | 20.1182 ± NA |
| BMS-986165 week 8 | 13.0328 ± NA | 12.9587 ± NA | 26.7961 ± NA |
| BMS-986165 week 12 | 10.7517 ± NA | 28.7751 ± NA | 22.1237 ± NA |
| BMS-986165 week 24 | 10.2546 ± NA | 13.9273 ± NA | 21.8720 ± NA |
| BMS-986165 week 32 | 8.5293 ± NA | 15.5285 ± NA | 24.5060 ± NA |
| BMS-986165 week 48 | 6.8493 ± NA | 21.7890 ± NA | 15.9576 ± NA |
| Metabolite BMT-153261 week 2 | 4.2667 ± NA | 8.4841 ± NA | 8.7920 ± NA |
| Metabolite BMT-153261 week 4 | 5.0886 ± NA | 7.7803 ± NA | 7.2703 ± NA |
| Metabolite BMT-153261 week 8 | 4.1293 ± NA | 5.2290 ± NA | 8.1451 ± NA |
| Metabolite BMT-153261 week 12 | 3.7325 ± NA | 9.3281 ± NA | 7.4071 ± NA |
| Metabolite BMT-153261 week 24 | 3.3669 ± NA | 5.2229 ± NA | 6.6608 ± NA |
| Metabolite BMT-153261 week 32 | 2.9759 ± NA | 5.2925 ± NA | 6.8734 ± NA |
| Metabolite BMT-153261 week 48 | 2.8708 ± NA | 6.8838 ± NA | 5.8602 ± NA |
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.
| Percent Change from Baseline | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| IFN High | -0.8130 ± 6.5323 | -39.7478 ± 13.0087 | -55.5691 ± 21.5313 | -47.5561 ± 12.2125 |
| IFN Low | 4.7381 ± 8.8696 | -18.0641 ± 27.0491 | -36.4510 ± 22.4759 | -41.7645 ± 26.1519 |
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.
| Percent Change from Baseline | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| IFN High | -4.3993 ± 5.2234 | -40.7944 ± 13.5929 | -54.6988 ± 16.7734 | -61.0515 ± 13.8367 |
| IFN Low | -2.6555 ± 9.2649 | -27.4897 ± 20.0078 | -42.8107 ± 19.7669 | -42.9701 ± 23.8323 |
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
| Percent Change from Baseline | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| C3 | 3.57 ± 12.225 | 5.33 ± 6.216 | 7.60 ± 5.315 | 14.74 ± 9.619 |
| C4 | 84.52 ± 88.618 | 3.57 ± 7.146 | 24.96 ± 20.508 | 20.43 ± 12.767 |
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
| Percent Change from Baseline | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| C3 | -0.58 ± 3.038 | 5.78 ± 3.161 | 12.42 ± 2.748 | 10.84 ± 2.896 |
| C4 | -3.27 ± 3.297 | 12.32 ± 4.455 | 16.71 ± 5.012 | 25.13 ± 6.988 |
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
| Percent Change from Baseline | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels | 276.26 ± 316.713 | 16.51 ± 28.265 | -31.79 ± 10.209 | -19.32 ± 8.722 |
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
| Percent Change from Baseline | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32 | 21.36 ± 15.135 | -15.24 ± 4.910 | -11.31 ± 6.323 | -24.17 ± 4.781 |
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
| Participants | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| IFN Low | 10 | 7 | 11 | 5 |
| IFN High | 21 | 46 | 35 | 35 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/90 (0%) | 11/90 (12.2%) | 52/90 (57.8%) |
| BMS-986165 3 mg | 0/91 (0%) | 7/91 (7.7%) | 56/91 (61.5%) |
| BMS-986165 6 mg | 0/93 (0%) | 8/93 (8.6%) | 60/93 (64.5%) |
| BMS-986165 12 mg | 0/89 (0%) | 7/89 (7.9%) | 45/89 (50.6%) |
| Event | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 2/90 | 0/91 | 2/93 | 0/89 |
| AnaemiaBlood and lymphatic system disorders | 0/90 | 0/91 | 0/93 | 1/89 |
| Coronary artery diseaseCardiac disorders | 0/90 | 0/91 | 0/93 | 1/89 |
| ScleritisEye disorders | 0/90 | 0/91 | 0/93 | 1/89 |
| Bile duct stoneHepatobiliary disorders | 0/90 | 0/91 | 0/93 | 1/89 |
| Hepatitis acuteHepatobiliary disorders | 0/90 | 0/91 | 0/93 | 1/89 |
| Urinary tract infectionInfections and infestations | 0/90 | 0/91 | 0/93 | 1/89 |
| Squamous cell carcinoma of the vaginaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/90 | 0/91 | 0/93 | 1/89 |
| Spinal cord disorderNervous system disorders | 0/90 | 0/91 | 0/93 | 1/89 |
| Endometrial hyperplasiaReproductive system and breast disorders | 0/90 | 0/91 | 0/93 | 1/89 |
| Event | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 8/90 | 13/91 | 18/93 | 8/89 |
| HeadacheNervous system disorders | 15/90 | 7/91 | 8/93 | 11/89 |
| NasopharyngitisInfections and infestations | 11/90 | 8/91 | 13/93 | 8/89 |
| Urinary tract infectionInfections and infestations | 3/90 | 10/91 | 6/93 | 6/89 |
| NauseaGastrointestinal disorders | 8/90 | 6/91 | 5/93 | 4/89 |
| DiarrhoeaGastrointestinal disorders | 5/90 | 4/91 | 8/93 | 3/89 |
| Back painMusculoskeletal and connective tissue disorders | 6/90 | 1/91 | 8/93 | 2/89 |
| AcneSkin and subcutaneous tissue disorders | 4/90 | 3/91 | 8/93 | 7/89 |
| RashSkin and subcutaneous tissue disorders | 0/90 | 2/91 | 3/93 | 7/89 |
| PharyngitisInfections and infestations | 2/90 | 7/91 | 5/93 | 2/89 |
| Age, Continuous(Years) | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg | Total |
|---|---|---|---|---|---|
| Mean | 40.1 ± 13.1 | 40.2 ± 11.9 | 40.9 ± 12.5 | 39.0 ± 10.6 | 40.1 ± 12.0 |
| Sex: Female, Male(Participants) | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg | Total |
|---|---|---|---|---|---|
| Female | 80 | 85 | 88 | 81 | 334 |
| Male | 10 | 6 | 5 | 8 | 29 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 31 | 31 | 29 | 36 | 127 |
| Not Hispanic or Latino | 58 | 60 | 64 | 53 | 235 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Placebo | BMS-986165 3 mg | BMS-986165 6 mg | BMS-986165 12 mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 3 | 5 | 2 | 14 |
| Asian | 10 | 9 | 15 | 10 | 44 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 10 | 8 | 9 | 33 |
| White | 60 | 62 | 55 | 57 | 234 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 10 | 7 | 10 | 11 | 38 |
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Lupus Erythematosus, Systemic→
Bristol-Myers Squibb