An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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).

Key facts

Study ID

NCT03943147

Run by

Bristol-Myers Squibb

People needed

16

Starts

2019-07-15

Expected to finish

2021-09-17

Last updated by the study team

2022-10-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Nephrology Associates of Northern Illinois and Indiana - Fort Wayne — Fort Wayne, Indiana, United States
• Johns Hopkins University, Office of Research Administration — Baltimore, Maryland, United States
• Renal and Transplant Associates of New England, PC — Springfield, Massachusetts, United States
• Brighton Center for Specialty Care — Brighton, Michigan, United States
• Clinical Research Consultants - Kansas City — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• Institute for Rheumatic and Autoimmune Diseases — Summit, New Jersey, United States
• NewYork-Presbyterian Queens — Fresh Meadows, New York, United States
• Northwell Health Physician Partners at Great Neck — Great Neck, New York, United States
• Local Institution - 0039 — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• State University of New York Upstate Medical University — Syracuse, New York, United States
• East Carolina University Physicians — Greenville, North Carolina, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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