An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
- Conditions
- Lupus Nephritis
- Interventions
- Registration Number
- NCT03943147
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986165 Dose 2 BMS-986165 Specified Dose on Specified Days Placebo for BMS-986165 Placebo Specified Dose on Specified Days Placebo for BMS-986165 Mycophenolate Mofetil Specified Dose on Specified Days Mycophenolate Mofetil (MMF) Mycophenolate Mofetil Specified Dose on Specified Days BMS-986165 Dose 1 BMS-986165 Specified Dose on Specified Days BMS-986165 Dose 2 Mycophenolate Mofetil Specified Dose on Specified Days BMS-986165 Dose 1 Mycophenolate Mofetil Specified Dose on Specified Days
- Primary Outcome Measures
Name Time Method The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B) From baseline up to 52 weeks after first dose in Part B The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B) From baseline up to 52 weeks after first dose in Part B An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B) From baseline up to 52 weeks after first dose in Part B The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B) From baseline up to 52 weeks after first dose in Part B The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B) Week 24 The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
- Secondary Outcome Measures
Name Time Method The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B) Week 52 The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B) Week 52 The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 52.
The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B) Week 24 The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B) Week 24 The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B) Week 24 The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B) Week 52 The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
Trial Locations
- Locations (87)
The Regents of The University of California
🇺🇸Los Angeles, California, United States
NewYork-Presbyterian Queens
🇺🇸Fresh Meadows, New York, United States
Northwell Health Physician Partners at Great Neck
🇺🇸Great Neck, New York, United States
Ohio State University, Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Nephrotex Research Group
🇺🇸Dallas, Texas, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States
Institute for Rheumatic and Autoimmune Diseases
🇺🇸Summit, New Jersey, United States
Local Institution - 0030
🇺🇸Charleston, South Carolina, United States
Centre Hospitalier Universitaire de Liege Site Sart Tilman
🇧🇪Liege, Belgium
Renal and Transplant Associates of New England, PC
🇺🇸Springfield, Massachusetts, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Local Institution - 0082
🇮🇹Milano, Italy
Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco
🇮🇹Milan, Italy
Universita degli Studi di Napoli Federico II
🇮🇹Napo, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Local Institution - 0066
🇺🇸Oklahoma City, Oklahoma, United States
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Revmatologicky Ustav
🇨🇿Praha 2, Czechia
Local Institution - 0037
🇨🇳Tainan, Taiwan
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom
Epsom and Saint Helier University Hospitals NHS Trust
🇬🇧Surrey, United Kingdom
Istituto Scientifico di Pavia
🇮🇹Pavia, Italy
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
🇲🇽Zapopan, Jalisco, Mexico
Local Institution - 0071
🇰🇷Daejeon, Korea, Republic of
Barts Health NHS Trust
🇬🇧London, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Centro Integral de Reumatologia
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Central Doctor Ignacio Morones Prieto
🇲🇽San Luis Potosi, Mexico
Medical Center
🇷🇺Kemerovo, Russian Federation
Local Institution
🇨🇳Taipei, Taiwan
Vseobecna Fakultni Nemocnice v Praze
🇨🇿Praha, Czechia
Morales Vargas Centro de Investigacion
🇲🇽Leon, Guanajuato, Mexico
Unidad de Investigacion de las Enfermedades Reumaticas
🇲🇽Ciudad de Mexico, Distrito Federal, Mexico
Local Institution - 0094
🇲🇽Mexico, Distrito Federal, Mexico
Servicios Hospitalarios de Mexico
🇲🇽Chihuahua, Mexico
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands
Fundacio Puigvert
🇪🇸Barcelona, Spain
City Clinical Hospital #15 named after O.M. Filatova
🇷🇺Moscow, Russian Federation
Centro de Atencion e Investigacion Cardiovascular del Potosi
🇲🇽San Luis Potosi, Mexico
Hospital Universitari Vall dHebron
🇪🇸Barcelona, Spain
Local Institution - 0015
🇷🇺Saratov, Russian Federation
V.A. Nasonova Research Rheumatology Institute
🇷🇺Moscow, Russian Federation
Local Institution - 0090
🇰🇷Gwangju, Korea, Republic of
Local Institution - 0056
🇰🇷Seoul, Korea, Republic of
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
🇩🇪Mainz, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Hospital Universitario Nuestra Senora de Valme
🇪🇸Sevilla, Spain
Local Institution - 0029
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Atlanta Nephrology Referral Center
🇺🇸Lawrenceville, Georgia, United States
Northwestern Medical Faculty Foundation
🇺🇸Chicago, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
🇺🇸Fort Wayne, Indiana, United States
The University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Johns Hopkins University, Office of Research Administration
🇺🇸Baltimore, Maryland, United States
Brighton Center for Specialty Care
🇺🇸Brighton, Michigan, United States
Clinical Research Consultants - Kansas City
🇺🇸Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0039
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Northeast Clinical Research Center
🇺🇸Bethlehem, Pennsylvania, United States
Dallas Nephrology Associates - North Office
🇺🇸Dallas, Texas, United States
El Paso Medical Research Institute
🇺🇸El Paso, Texas, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Sheldon M. Chumir Health Center
🇨🇦Calgary, Alberta, Canada
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
🇨🇦Quebec, Canada
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga Hospital General
🇪🇸Malaga, Spain
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
East Carolina University Physicians
🇺🇸Greenville, North Carolina, United States
The Nephrology Group
🇺🇸Fresno, California, United States
Office of Ramesh C. Gupta, MD
🇺🇸Memphis, Tennessee, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States