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-986165compared 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 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

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose 1
Specified Dose on Specified Days
  • Drug: BMS-986165
    Specified dose on specified days
Experimental
Dose 2
Specified Dose on Specified Days
  • Drug: BMS-986165
    Specified dose on specified days
Placebo Comparator
Placebo
Specified Dose on Specified Days
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294-3300
Contact:
Emmy Bell, Site 0100
205-975-0549

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
please email:
Clinical.Trials@bms.com