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

Purpose

The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).

Condition

  • Lupus Nephritis

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for Systemic Lupus Erythematosus (SLE) - Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN) International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III, IV-S, or IV-G; or Class V - Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a 24-hour urine specimen

Exclusion Criteria

  • Pure ISN/RPS Class V membranous LN - Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m^2 - Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study - End-stage renal disease Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind Study

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BMS-986165 Dose 1
Specified Dose on Specified Days
  • Drug: BMS-986165
    Specified dose on specified days
  • Drug: Mycophenolate Mofetil
    Specified dose on specified days
Experimental
BMS-986165 Dose 2
Specified Dose on Specified Days
  • Drug: BMS-986165
    Specified dose on specified days
  • Drug: Mycophenolate Mofetil
    Specified dose on specified days
Placebo Comparator
Placebo for BMS-986165
Specified Dose on Specified Days
  • Drug: Placebo
    Specified dose on specified days
  • Drug: Mycophenolate Mofetil
    Specified dose on specified days
Experimental
Mycophenolate Mofetil (MMF)
Specified Dose on Specified Days
  • Drug: Mycophenolate Mofetil
    Specified dose on specified days

More Details

Status
Terminated
Sponsor
Bristol-Myers Squibb

Study Contact