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

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
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lupus Nephritis Drug: BMS-986165 Drug: Placebo Drug: Mycophenolate Mofetil Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: From Baseline to 52 Weeks ]
  2. Number of clinically significant changes in vital signs: Heart Rate [ Time Frame: From Baseline to 52 Weeks ]
  3. Number of clinically significant changes in vital signs: Blood Pressure [ Time Frame: From Baseline to 52 Weeks ]
  4. Number of clinically significant changes in vital signs: Respiratory Rate [ Time Frame: From Baseline to 52 Weeks ]
  5. Number of clinically significant changes in vital signs: Temperature [ Time Frame: From Baseline to 52 Weeks ]
  6. Number of clinically significant changes in ECG (electrocardiogram) [ Time Frame: From Baseline to 52 Weeks ]
  7. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: From Baseline to 52 Weeks ]
  8. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: From Baseline to 52 Weeks ]
  9. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [ Time Frame: From Baseline to 52 Weeks ]
  10. Incidence of clinically significant changes in clinical laboratory values: Coagulation tests [ Time Frame: From Baseline to 52 Weeks ]
  11. Percentage change from baseline in 24-hour Urine Protein:Creatinine Ratio(UPCR) [ Time Frame: At Week 24 ]

Secondary Outcome Measures :
  1. Partial renal response (PRR) [ Time Frame: At Week 24 ]
    PRR defined as ≥50% reduction from baseline in 24-hour UPCR

  2. 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

  3. CRR [ Time Frame: At Week 52 ]
  4. CRR + successful corticosteroid (CS) taper ≤7.5 mg/day [ Time Frame: At Week 24 ]
  5. CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 52 ]
  6. PRR [ Time Frame: At Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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