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Phase 2
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18-75Age Range
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Active, Not Recruiting
Active, Not Recruiting
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for SLE - Renal biopsy confirming a histologic diagnosis of active LN: International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III (A or A/C), IV-S (A or A/C), or IV-G (A or A/C); or Class V (in combination with Class III or IV) - Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg Exclusion Criteria: - Pure ISN/RPS Class V membranous LN - Screening estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease [MDRD] equation) ≤30 mL/min/1.73 m2 - Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study Other protocol defined inclusion/exclusion criteria could apply
Experimental: Dose 1
Experimental: Dose 2
Placebo Comparator: Placebo