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  • NCT03943147

Active, Not Recruiting

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

Updated: 29 July, 2021   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-75

    Age Range

  • Active, Not Recruiting

Treatment Options

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

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