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

September 16, 2022 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 1871
        • Liverpool Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Belgium
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liège Site Sart Tilman
  • Canada
      • Quebec, Canada, G1V 3M7
        • Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Sheldon M. Chumir Health Center
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Toronto Western Hospital
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Local Institution
    • Shan3xi
      • Xian, Shan3xi, China, 710061
        • Local Institution
  • Czechia
      • Praha, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
      • Praha 2, Czechia, 12850
        • Revmatologicky Ustav
  • Germany
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Mainz, Germany, 55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
  • Israel
      • Haifa, Israel, 3339419
        • Local Institution
      • Kfar Saba, Israel, 4428164
        • Local Institution
      • Tel Aviv, Israel, 6423906
        • Local Institution
  • Italy
      • Milan, Italy, 20157
        • Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco
      • Milano, Italy, 20132
        • Local Institution - 0082
      • Napo, Italy, 80131
        • Universita degli Studi di Napoli Federico II
      • Pavia, Italy, 27100
        • Istituto Scientifico di Pavia
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Local Institution
      • Daejeon, Korea, Republic of, 35015
        • Local Institution - 0071
      • Gwangju, Korea, Republic of, 61469
        • Local Institution - 0090
      • Seoul, Korea, Republic of, 137-701
        • Local Institution
      • Seoul, Korea, Republic of, 05030
        • Local Institution
      • Seoul, Korea, Republic of, 05505
        • Local Institution
      • Seoul, Korea, Republic of, 03080
        • Local Institution - 0056
      • Suwon, Korea, Republic of, 442-723
        • Local Institution
  • Mexico
      • Chihuahua, Mexico, 31217
        • Servicios Hospitalarios de Mexico
      • San Luis Potosi, Mexico, 78200
        • Centro de Atención e Investigación Cardiovascular del Potosí
      • San Luis Potosi, Mexico, 78240
        • Hospital Central Doctor Ignacio Morones Prieto
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 06090
        • Unidad de Investigacion de las Enfermedades Reumaticas
      • Mexico, Distrito Federal, Mexico, 11850
        • Local Institution - 0094
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro Integral de Reumatología
      • Zapopan, Jalisco, Mexico, 45030
        • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Centre
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
  • Russian Federation
      • Kemerovo, Russian Federation, 650070
        • Medical Center
      • Moscow, Russian Federation, 111539
        • City Clinical Hospital #15 named after O.M. Filatova
      • Moscow, Russian Federation, 115522
        • V.A. Nasonova Research Rheumatology Institute
      • Saratov, Russian Federation, 410053
        • Local Institution - 0015
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08025
        • Fundacio Puigvert
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall dHebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de Malaga Hospital General
      • Sevilla, Spain, 41014
        • Hospital Universitario Nuestra Señora de Valme
  • Taiwan
      • Hualien, Taiwan, 97002
        • Local Institution
      • Kaohsiung City, Taiwan, 833
        • Local Institution
      • Taichung, Taiwan, 40705
        • Local Institution
      • Tainan, Taiwan, 71004
        • Local Institution - 0037
      • Taipei, Taiwan, 112
        • Local Institution
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Brighton and Sussex University Hospitals NHS Trust
      • Cambridge, United Kingdom, CB2 2QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Leicester, United Kingdom, LE5 4PW
        • University Hospitals of Leicester NHS Trust
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust
      • Surrey, United Kingdom, SM5 1AA
        • Epsom and Saint Helier University Hospitals NHS Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • California
      • Fresno, California, United States, 93720
        • The Nephrology Group
      • Los Angeles, California, United States, 90095
        • The Regents of the University of California
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine
    • Florida
      • Gainesville, Florida, United States, 32603
        • Local Institution - 0029
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Lawrenceville, Georgia, United States, 30046
        • Atlanta Nephrology Referral Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine
      • Chicago, Illinois, United States, 60611-5966
        • Northwestern Medical Faculty Foundation
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University, Office of Research Administration
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Renal and Transplant Associates of New England, PC
    • Michigan
      • Brighton, Michigan, United States, 48116
        • Brighton Center for Specialty Care
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Clinical Research Consultants - Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
      • Summit, New Jersey, United States, 07901
        • Institute for Rheumatic and Autoimmune Diseases
    • New York
      • Fresh Meadows, New York, United States, 11365
        • NewYork-Presbyterian Queens
      • Great Neck, New York, United States, 11021
        • Northwell Health Physician Partners at Great Neck
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • Local Institution - 0039
      • Syracuse, New York, United States, 13210-2342
        • State University of New York Upstate Medical University
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University Physicians
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University, Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Local Institution - 0066
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Northeast Clinical Research Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0030
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Office of Ramesh C. Gupta, MD
    • Texas
      • Dallas, Texas, United States, 75231
        • Nephrotex Research Group
      • Dallas, Texas, United States, 75240
        • Dallas Nephrology Associates - North Office
      • El Paso, Texas, United States, 79902
        • El Paso Medical Research Institute
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98195-6340
        • University of Washington School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)
Time Frame: 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.
From baseline up to 52 weeks after first dose in Part B
The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)
Time Frame: 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.
From baseline up to 52 weeks after first dose in Part B
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
Time Frame: 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.
From baseline up to 52 weeks after first dose in Part B
The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)
Time Frame: 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.
From baseline up to 52 weeks after first dose 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)
Time Frame: 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.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)
Time Frame: 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.
Week 24
The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)
Time Frame: 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.
Week 52
The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)
Time Frame: 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.
Week 24
The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)
Time Frame: 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.
Week 52
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)
Time Frame: 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.
Week 24
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)
Time Frame: 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.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2019

Primary Completion (ACTUAL)

October 29, 2020

Study Completion (ACTUAL)

September 17, 2021

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (ACTUAL)

May 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 17, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-073
  • 2018-004142-42 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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