An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
Purpose
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).
Condition
- Lupus Nephritis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double-blind Study
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BMS-986165 Dose 1 |
Specified Dose on Specified Days |
|
|
Experimental BMS-986165 Dose 2 |
Specified Dose on Specified Days |
|
|
Placebo Comparator Placebo for BMS-986165 |
Specified Dose on Specified Days |
|
|
Experimental Mycophenolate Mofetil (MMF) |
Specified Dose on Specified Days |
|
More Details
- Status
- Terminated
- Sponsor
- Bristol-Myers Squibb