An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03943147 |
Recruitment Status :
Terminated
(Insufficient enrollment)
First Posted : May 9, 2019
Last Update Posted : November 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lupus Nephritis | Drug: BMS-986165 Drug: Placebo Drug: Mycophenolate Mofetil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-blind Study |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis |
Actual Study Start Date : | July 15, 2019 |
Actual Primary Completion Date : | October 29, 2020 |
Actual Study Completion Date : | September 17, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: BMS-986165 Dose 1
Specified Dose on Specified Days
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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 |
- Incidence of Adverse Events (AEs) [ Time Frame: From Baseline to 52 Weeks ]
- Number of clinically significant changes in vital signs: Heart Rate [ Time Frame: From Baseline to 52 Weeks ]
- Number of clinically significant changes in vital signs: Blood Pressure [ Time Frame: From Baseline to 52 Weeks ]
- Number of clinically significant changes in vital signs: Respiratory Rate [ Time Frame: From Baseline to 52 Weeks ]
- Number of clinically significant changes in vital signs: Temperature [ Time Frame: From Baseline to 52 Weeks ]
- Number of clinically significant changes in ECG (electrocardiogram) [ Time Frame: From Baseline to 52 Weeks ]
- Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: From Baseline to 52 Weeks ]
- Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: From Baseline to 52 Weeks ]
- Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [ Time Frame: From Baseline to 52 Weeks ]
- Incidence of clinically significant changes in clinical laboratory values: Coagulation tests [ Time Frame: From Baseline to 52 Weeks ]
- Percentage change from baseline in 24-hour Urine Protein:Creatinine Ratio(UPCR) [ Time Frame: At Week 24 ]
- Partial renal response (PRR) [ Time Frame: At Week 24 ]PRR defined as ≥50% reduction from baseline in 24-hour UPCR
- Complete renal response (CRR) [ Time Frame: At Week 24 ]CRR defined as 24-hour UPCR ≤ 0.5mg/mg and estimated glomerular filtration rate (eGFR) ≥ 60mL/min or ≤ 20% decrease from baseline
- CRR [ Time Frame: At Week 52 ]
- CRR + successful corticosteroid (CS) taper ≤7.5 mg/day [ Time Frame: At Week 24 ]
- CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 52 ]
- PRR [ Time Frame: At Week 52 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943147

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03943147 |
Other Study ID Numbers: |
IM011-073 2018-004142-42 ( EudraCT Number ) |
First Posted: | May 9, 2019 Key Record Dates |
Last Update Posted: | November 2, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Mycophenolic Acid BMS-986165 |
Antibiotics, Antineoplastic Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dermatologic Agents Protein Kinase Inhibitors |