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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Lupus Nephritis

Treatments: Drug: Placebo; Drug: BMS-986165; Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT03943147

IM011-073

2018-004142-42 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups, including a placebo group

BMS-986165 Dose 1

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Mycophenolate Mofetil

Drug: BMS-986165

BMS-986165 Dose 2

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Mycophenolate Mofetil

Drug: BMS-986165

Placebo for BMS-986165

Placebo Comparator group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Placebo

Drug: Mycophenolate Mofetil

Mycophenolate Mofetil (MMF)

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Drug: Mycophenolate Mofetil