An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
- Conditions
- Lupus Nephritis
- Interventions
- Registration Number
- NCT03943147
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for Systemic Lupus Erythematosus (SLE)
- Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN) International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III, IV-S, or IV-G; or Class V
- Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a 24-hour urine specimen
- Pure ISN/RPS Class V membranous LN
- Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m^2
- Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study
- End-stage renal disease
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986165 Dose 2 BMS-986165 Specified Dose on Specified Days Placebo for BMS-986165 Placebo Specified Dose on Specified Days Placebo for BMS-986165 Mycophenolate Mofetil Specified Dose on Specified Days Mycophenolate Mofetil (MMF) Mycophenolate Mofetil Specified Dose on Specified Days BMS-986165 Dose 1 BMS-986165 Specified Dose on Specified Days BMS-986165 Dose 2 Mycophenolate Mofetil Specified Dose on Specified Days BMS-986165 Dose 1 Mycophenolate Mofetil Specified Dose on Specified Days
- Primary Outcome Measures
Name Time Method The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B) From baseline up to 52 weeks after first dose in Part B The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B) From baseline up to 52 weeks after first dose in Part B An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B) From baseline up to 52 weeks after first dose in Part B The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B) From baseline up to 52 weeks after first dose in Part B The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B) Week 24 The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
- Secondary Outcome Measures
Name Time Method The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B) Week 52 The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B) Week 52 The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 52.
The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B) Week 24 The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B) Week 24 The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B) Week 24 The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B) Week 52 The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
Trial Locations
- Locations (87)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Nephrology Group
🇺🇸Fresno, California, United States
The Regents of The University of California
🇺🇸Los Angeles, California, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Local Institution - 0029
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Atlanta Nephrology Referral Center
🇺🇸Lawrenceville, Georgia, United States
Northwestern Medical Faculty Foundation
🇺🇸Chicago, Illinois, United States
The University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
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