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

Lupus Nephritis Clinical Trial

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

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
• 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
• 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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls