An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
NCT ID: NCT03943147
Last Updated: 2022-10-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2019-07-15
2021-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986165 Dose 1
Specified Dose on Specified Days
BMS-986165
Specified dose on specified days
Mycophenolate Mofetil
Specified dose on specified days
BMS-986165 Dose 2
Specified Dose on Specified Days
BMS-986165
Specified dose on specified days
Mycophenolate Mofetil
Specified dose on specified days
Placebo for BMS-986165
Specified Dose on Specified Days
Placebo
Specified dose on specified days
Mycophenolate Mofetil
Specified dose on specified days
Mycophenolate Mofetil (MMF)
Specified Dose on Specified Days
Mycophenolate Mofetil
Specified dose on specified days
Interventions
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BMS-986165
Specified dose on specified days
Placebo
Specified dose on specified days
Mycophenolate Mofetil
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
The Nephrology Group
Fresno, California, United States
The Regents of The University of California
Los Angeles, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Local Institution - 0029
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Atlanta Nephrology Referral Center
Lawrenceville, Georgia, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
Fort Wayne, Indiana, United States
Johns Hopkins University, Office of Research Administration
Baltimore, Maryland, United States
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, 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
St Louis, Missouri, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Institute for Rheumatic and Autoimmune Diseases
Summit, New Jersey, United States
NewYork-Presbyterian Queens
Fresh Meadows, New York, United States
Northwell Health Physician Partners at Great Neck
Great Neck, New York, 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
State University of New York Upstate Medical University
Syracuse, New York, United States
East Carolina University Physicians
Greenville, North Carolina, United States
Ohio State University, Wexner Medical Center
Columbus, Ohio, United States
Local Institution - 0066
Oklahoma City, Oklahoma, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Local Institution - 0030
Charleston, South Carolina, United States
Office of Ramesh C. Gupta, MD
Memphis, Tennessee, United States
Nephrotex Research Group
Dallas, Texas, United States
Dallas Nephrology Associates - North Office
Dallas, Texas, United States
El Paso Medical Research Institute
El Paso, Texas, United States
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
Liverpool Hospital
Liverpool, New South Wales, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege Site Sart Tilman
Liège, , Belgium
Sheldon M. Chumir Health Center
Calgary, Alberta, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
Québec, Quebec, Canada
Local Institution
Guangzhou, Guangdong, China
Local Institution
Xi'an, Shan3xi, China
Vseobecna Fakultni Nemocnice v Praze
Prague, , Czechia
Revmatologicky Ustav
Prague, , Czechia
Universitaetsklinikum Essen
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, , Germany
Local Institution
Haifa, , Israel
Local Institution
Kfar Saba, , Israel
Local Institution
Tel Aviv, , Israel
Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco
Milan, , Italy
Local Institution - 0082
Milan, , Italy
Universita degli Studi di Napoli Federico II
Napo, , Italy
Istituto Scientifico di Pavia
Pavia, , Italy
Morales Vargas Centro de Investigacion
León, Guanajuato, Mexico
Centro Integral de Reumatologia
Guadalajara, Jalisco, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, Mexico
Unidad de Investigacion de las Enfermedades Reumaticas
Mexico City, Mexico City, Mexico
Local Institution - 0094
Mexico City, Mexico City, Mexico
Servicios Hospitalarios de Mexico
Chihuahua City, , Mexico
Centro de Atencion e Investigacion Cardiovascular del Potosi
San Luis Potosí City, , Mexico
Hospital Central Doctor Ignacio Morones Prieto
San Luis Potosí City, , Mexico
Maastricht University Medical Centre
Maastricht, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Medical Center
Kemerovo, , Russia
City Clinical Hospital #15 named after O.M. Filatova
Moscow, , Russia
V.A. Nasonova Research Rheumatology Institute
Moscow, , Russia
Local Institution - 0015
Saratov, , Russia
Local Institution
Busan, , South Korea
Local Institution - 0071
Daejeon, , South Korea
Local Institution - 0090
Gwangju, , South Korea
Local Institution - 0056
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Suwon, , South Korea
Fundacio Puigvert
Barcelona, , Spain
Hospital Universitari Vall dHebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional Universitario de Malaga Hospital General
Málaga, , Spain
Hospital Universitario Nuestra Senora de Valme
Seville, , Spain
Local Institution
Hualien City, , Taiwan
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution - 0037
Tainan City, , Taiwan
Local Institution
Taipei, , Taiwan
Brighton and Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Epsom and Saint Helier University Hospitals NHS Trust
Surrey, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Investigator Inquiry Form
Other Identifiers
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2018-004142-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM011-073
Identifier Type: -
Identifier Source: org_study_id
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