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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03943147
Other study ID # IM011-073
Secondary ID 2018-004142-42
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 15, 2019
Est. completion date September 17, 2021

Study information

Verified date September 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date September 17, 2021
Est. primary completion date October 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986165
Specified dose on specified days
Placebo
Specified dose on specified days
Mycophenolate Mofetil
Specified dose on specified days

Locations

Country Name City State
Australia Liverpool Hospital Liverpool New South Wales
Australia Sir Charles Gairdner Hospital Nedlands Western Australia
Belgium Universitair Ziekenhuis Leuven Leuven
Belgium Centre Hospitalier Universitaire de Liege Site Sart Tilman Liege
Canada Sheldon M. Chumir Health Center Calgary Alberta
Canada Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval Quebec
Canada Toronto Western Hospital Toronto Ontario
China Local Institution Guangzhou Guangdong
China Local Institution Xian Shan3xi
Czechia Vseobecna Fakultni Nemocnice v Praze Praha
Czechia Revmatologicky Ustav Praha 2
Germany Universitaetsklinikum Essen Essen
Germany Medizinische Hochschule Hannover Hannover
Germany Universitatsmedizin der Johannes Gutenberg Universitat Mainz Mainz
Israel Local Institution Haifa
Israel Local Institution Kfar Saba
Israel Local Institution Tel Aviv
Italy Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco Milan
Italy Local Institution - 0082 Milano
Italy Universita degli Studi di Napoli Federico II Napo
Italy Istituto Scientifico di Pavia Pavia
Korea, Republic of Local Institution Busan
Korea, Republic of Local Institution - 0071 Daejeon
Korea, Republic of Local Institution - 0090 Gwangju
Korea, Republic of Local Institution Seoul
Korea, Republic of Local Institution Seoul
Korea, Republic of Local Institution Seoul
Korea, Republic of Local Institution - 0056 Seoul
Korea, Republic of Local Institution Suwon
Mexico Servicios Hospitalarios de Mexico Chihuahua
Mexico Unidad de Investigacion de las Enfermedades Reumaticas Ciudad de Mexico Distrito Federal
Mexico Centro Integral de Reumatologia Guadalajara Jalisco
Mexico Morales Vargas Centro de Investigacion Leon Guanajuato
Mexico Local Institution - 0094 Mexico Distrito Federal
Mexico Centro de Atencion e Investigacion Cardiovascular del Potosi San Luis Potosi
Mexico Hospital Central Doctor Ignacio Morones Prieto San Luis Potosi
Mexico Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Zapopan Jalisco
Netherlands Maastricht University Medical Centre Maastricht
Netherlands Erasmus Medisch Centrum Rotterdam
Russian Federation Medical Center Kemerovo
Russian Federation City Clinical Hospital #15 named after O.M. Filatova Moscow
Russian Federation V.A. Nasonova Research Rheumatology Institute Moscow
Russian Federation Local Institution - 0015 Saratov
Spain Fundacio Puigvert Barcelona
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitari Vall dHebron Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Regional Universitario de Malaga Hospital General Malaga
Spain Hospital Universitario Nuestra Senora de Valme Sevilla
Taiwan Local Institution Hualien
Taiwan Local Institution Kaohsiung City
Taiwan Local Institution Taichung
Taiwan Local Institution - 0037 Tainan
Taiwan Local Institution Taipei
United Kingdom 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 States Emory University Atlanta Georgia
United States Augusta University Augusta Georgia
United States University of Colorado School of Medicine Aurora Colorado
United States Johns Hopkins University, Office of Research Administration Baltimore Maryland
United States Northeast Clinical Research Center Bethlehem Pennsylvania
United States University of Alabama at Birmingham Birmingham Alabama
United States Brighton Center for Specialty Care Brighton Michigan
United States Local Institution - 0030 Charleston South Carolina
United States Northwestern Medical Faculty Foundation Chicago Illinois
United States The University of Chicago Medicine Chicago Illinois
United States Ohio State University, Wexner Medical Center Columbus Ohio
United States Dallas Nephrology Associates - North Office Dallas Texas
United States Nephrotex Research Group Dallas Texas
United States El Paso Medical Research Institute El Paso Texas
United States Nephrology Associates of Northern Illinois and Indiana - Fort Wayne Fort Wayne Indiana
United States NewYork-Presbyterian Queens Fresh Meadows New York
United States The Nephrology Group Fresno California
United States Local Institution - 0029 Gainesville Florida
United States Northwell Health Physician Partners at Great Neck Great Neck New York
United States East Carolina University Physicians Greenville North Carolina
United States The University of Texas Health Science Center at Houston Houston Texas
United States Clinical Research Consultants - Kansas City Kansas City Missouri
United States Atlanta Nephrology Referral Center Lawrenceville Georgia
United States The Regents of The University of California Los Angeles California
United States Office of Ramesh C. Gupta, MD Memphis Tennessee
United States Columbia University Medical Center New York New York
United States Icahn School of Medicine at Mount Sinai New York New York
United States Local Institution - 0039 New York New York
United States Rutgers New Jersey Medical School Newark New Jersey
United States Local Institution - 0066 Oklahoma City Oklahoma
United States Temple University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States Washington University School of Medicine Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States University of Washington School of Medicine Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Renal and Transplant Associates of New England, PC Springfield Massachusetts
United States Institute for Rheumatic and Autoimmune Diseases Summit New Jersey
United States State University of New York Upstate Medical University Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Czechia,  Germany,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (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. From baseline up to 52 weeks after first dose in Part B
Primary The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (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. From baseline up to 52 weeks after first dose in Part B
Primary The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (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. From baseline up to 52 weeks after first dose in Part B
Primary The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (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. From baseline up to 52 weeks after first dose in Part B
Primary Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B) 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. Week 24
Secondary The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B) 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. Week 24
Secondary The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B) 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. Week 52
Secondary The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B) 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. Week 24
Secondary The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B) 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. Week 52
Secondary 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) 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. Week 24
Secondary 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) 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. Week 52
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