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

Purpose

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.

Visit the ClinicalTrials.gov website for more information >



Study procedures

If you are eligible to participate, you may be asked to complete the following:

  • Questionnaires
  • 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.



Eligibility

  • 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.



Contact

For questions about this study, please reach out to Sofia Dayi:

Age

18 to 65
65 and over

Monetary compensation

Yes

Can be done from home

No

Keywords

Lupus nephritis, Nephritis

Principal Investigator

Michael Bubb, MD

Contact Information

sofia.dayi@medicine.ufl.edu

(352) 273-6662


Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at UFStudies@health.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

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