A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis
Bristol-Myers Squibb Company (the Sponsor) is running a research study to see if a test medicine named BMS-986165 will help treat kidney inflammation caused by lupus (lupus nephritis). It will also test how safe it is to use the medicine in people. This test medicine is not yet approved for sale to patients.
If you are eligible to participate, you may be asked to complete the following:
- Electrocardiogram (ECG)
- Kidney Biopsies
- Blood samples
- PK samples
- Urine samples
- Screening X-ray of the chest
The study team will discuss all study details with you.
- 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
Additional criteria may apply.
For questions about this study, please reach out to Sofia Dayi:
- Phone: (352) 273-6662
- Email: firstname.lastname@example.org
Can be done from home
KeywordsLupus nephritis, Nephritis
Principal InvestigatorMichael Bubb, MD
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