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

NCT03943147 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM011-0732018-004142-42
• Study Type: interventional
• Target: 16
• Locations: 16 countries
• Sites: 100

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).

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• 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) at Week 52 in the Blinded Treatment Period (Part B)

  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) at Week 52 in the Blinded Treatment Period (Part B)

  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)

  Week 24

Study Arms (4)

BMS-986165 Dose 1

EXPERIMENTAL

Specified Dose on Specified Days

Drug: BMS-986165; Drug: Mycophenolate Mofetil

BMS-986165 Dose 2

EXPERIMENTAL

Specified Dose on Specified Days

Drug: BMS-986165; Drug: Mycophenolate Mofetil

Placebo for BMS-986165

PLACEBO COMPARATOR

Specified Dose on Specified Days

Drug: Placebo; Drug: Mycophenolate Mofetil

Mycophenolate Mofetil (MMF)

EXPERIMENTAL

Specified Dose on Specified Days

Drug: Mycophenolate Mofetil

Interventions

BMS-986165 DRUG

Specified dose on specified days

BMS-986165 Dose 1; BMS-986165 Dose 2

Placebo DRUG

Specified dose on specified days

Placebo for BMS-986165

Mycophenolate Mofetil DRUG

Specified dose on specified days

BMS-986165 Dose 1; BMS-986165 Dose 2; Mycophenolate Mofetil (MMF); Placebo for BMS-986165

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (100)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

The Nephrology Group

Fresno, California, 93720, United States

Location

The Regents of The University of California

Los Angeles, California, 90095, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Local Institution - 0029

Gainesville, Florida, 32603, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Atlanta Nephrology Referral Center

Lawrenceville, Georgia, 30046, United States

Location

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611-5966, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Nephrology Associates of Northern Illinois and Indiana - Fort Wayne

Fort Wayne, Indiana, 46804, United States

Location

Johns Hopkins University, Office of Research Administration

Baltimore, Maryland, 21205, United States

Location

Renal and Transplant Associates of New England, PC

Springfield, Massachusetts, 01107, United States

Location

Brighton Center for Specialty Care

Brighton, Michigan, 48116, United States

Location

Clinical Research Consultants - Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Institute for Rheumatic and Autoimmune Diseases

Summit, New Jersey, 07901, United States

Location

NewYork-Presbyterian Queens

Fresh Meadows, New York, 11365, United States

Location

Northwell Health Physician Partners at Great Neck

Great Neck, New York, 11021, United States

Location

Local Institution - 0039

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210-2342, United States

Location

East Carolina University Physicians

Greenville, North Carolina, 27834, United States

Location

Ohio State University, Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Local Institution - 0066

Oklahoma City, Oklahoma, 73104, United States

Location

Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Local Institution - 0030

Charleston, South Carolina, 29425, United States

Location

Office of Ramesh C. Gupta, MD

Memphis, Tennessee, 38119, United States

Location

Nephrotex Research Group

Dallas, Texas, 75231, United States

Location

Dallas Nephrology Associates - North Office

Dallas, Texas, 75240, United States

Location

El Paso Medical Research Institute

El Paso, Texas, 79902, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195-6340, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 1871, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liege Site Sart Tilman

Liège, 4000, Belgium

Location

Sheldon M. Chumir Health Center

Calgary, Alberta, T2N 4Z6, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 3A9, Canada

Location

Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval

Québec, Quebec, G1V 3M7, Canada

Location

Local Institution

Guangzhou, Guangdong, 510080, China

Location

Local Institution

Xi'an, Shan3xi, 710061, China

Location

Vseobecna Fakultni Nemocnice v Praze

Prague, 128 08, Czechia

Location

Revmatologicky Ustav

Prague, 12850, Czechia

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, 55131, Germany

Location

Local Institution

Haifa, 3339419, Israel

Location

Local Institution

Kfar Saba, 4428164, Israel

Location

Local Institution

Tel Aviv, 6423906, Israel

Location

Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Local Institution - 0082

Milan, 20132, Italy

Location

Universita degli Studi di Napoli Federico II

Napo, 80131, Italy

Location

Istituto Scientifico di Pavia

Pavia, 27100, Italy

Location

Morales Vargas Centro de Investigacion

León, Guanajuato, 37000, Mexico

Location

Centro Integral de Reumatologia

Guadalajara, Jalisco, 44160, Mexico

Location

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Zapopan, Jalisco, 45030, Mexico

Location

Unidad de Investigacion de las Enfermedades Reumaticas

Mexico City, Mexico City, 06090, Mexico

Location

Local Institution - 0094

Mexico City, Mexico City, 11850, Mexico

Location

Servicios Hospitalarios de Mexico

Chihuahua City, 31217, Mexico

Location

Centro de Atencion e Investigacion Cardiovascular del Potosi

San Luis Potosí City, 78200, Mexico

Location

Hospital Central Doctor Ignacio Morones Prieto

San Luis Potosí City, 78240, Mexico

Location

Maastricht University Medical Centre

Maastricht, 6229 HX, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Medical Center

Kemerovo, 650070, Russia

Location

City Clinical Hospital #15 named after O.M. Filatova

Moscow, 111539, Russia

Location

V.A. Nasonova Research Rheumatology Institute

Moscow, 115522, Russia

Location

Local Institution - 0015

Saratov, 410053, Russia

Location

Local Institution

Busan, 602-715, South Korea

Location

Local Institution - 0071

Daejeon, 35015, South Korea

Location

Local Institution - 0090

Gwangju, 61469, South Korea

Location

Local Institution - 0056

Seoul, 03080, South Korea

Location

Local Institution

Seoul, 05030, South Korea

Location

Local Institution

Seoul, 05505, South Korea

Location

Local Institution

Seoul, 137-701, South Korea

Location

Local Institution

Suwon, 442-723, South Korea

Location

Fundacio Puigvert

Barcelona, 08025, Spain

Location

Hospital Universitari Vall dHebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario de Malaga Hospital General

Málaga, 29010, Spain

Location

Hospital Universitario Nuestra Senora de Valme

Seville, 41014, Spain

Location

Local Institution

Hualien City, 97002, Taiwan

Location

Local Institution

Kaohsiung City, 833, Taiwan

Location

Local Institution

Taichung, 40705, Taiwan

Location

Local Institution - 0037

Tainan, 71004, Taiwan

Location

Local Institution

Taipei, 112, Taiwan

Location

Brighton and Sussex University Hospitals NHS Trust

Brighton, BN2 5BE, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 2QQ, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE5 4PW, United Kingdom

Location

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Epsom and Saint Helier University Hospitals NHS Trust

Surrey, SM5 1AA, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Lupus Nephritis

Interventions

deucravacitinib; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Limitations and Caveats

Due to low enrollment, the Sponsor chose to terminate the study on 01-Jul-2021 and consequently there is limited data available from a single randomized participant. Due to lack of sufficient data, no formal statistical analyses of endpoints were conducted.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 9, 2019
• Study Start: July 15, 2019
• Primary Completion: October 29, 2020
• Study Completion: September 17, 2021
• Last Updated: October 17, 2022
• Results First Posted: October 17, 2022

Record last verified: 2022-09

Locations

ES (6); IL (3); KR (8); CN (2); IT (4); RU (4); AU (2); BE (2); CA (3); NL (2); TW (5); GB (6); CZ (2); US (40); DE (3); ME (8)