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Recruiting

An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis - IM011-073

Updated: 07 May, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-75

    Age Range

  • 57

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: BMS-986165 Dose 1 oral administration
Drug: BMS-986165
Experimental: BMS-986165 Dose 2 oral administration
Drug: BMS-986165
Placebo Comparator: Placebo oral administration
Drug: Placebo

Key Eligibility Criteria

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 Society 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

Have questions? Live support is available 24/7 - Call 855-907-3286 or Email Us

Have questions? Live support is available 24/7 -
Call 855-907-3286 or Email Us