A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

Purpose

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

Condition

  • Progressive Pulmonary Fibrosis

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT). - If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening. - If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening. - Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening. - Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening. - Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening. - Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test. - Men who are sexually active with women of childbearing potential agree to use male barrier contraception.

Exclusion Criteria

  • Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening. - History of stroke or transient ischemic attack within 3 months prior to screening. - Participants who exhibit symptoms of heart failure at rest. - Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ. - Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BMS-986278 Dose 1
  • Drug: BMS-986278
    Specified dose on specified days
Experimental
BMS-986278 Dose 2
  • Drug: BMS-986278
    Specified dose on specified days
Placebo Comparator
BMS-986278 Placebo
  • Drug: BMS-986278 Placebo
    Specified dose on specified days

Recruiting Locations

The University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Tejaswini Kulkarni, Site 0046
617-480-7076

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033-2360
Contact:
Rebecca Bascom, Site 0205
717-531-2925

The Lung Research Center
Chesterfield, Missouri 63017
Contact:
Neil Ettinger, Site 0004
314-682-3653

Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63110-1010
Contact:
Mary Clare McGregor, Site 0223
314-362-9919

Northern Westchester Hospital
Mount Kisco, New York 10549-3417
Contact:
Bushra Ayad Mina, Site 0068
212-794-2800

Icahn School of Medicine at Mount Sinai
New York, New York 10029-6574
Contact:
Maria Padilla, Site 0357
212-241-5656

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Aparna Swaminathan, Site 0428
610-442-9029

Accellacare US Inc. of Wilmington
Wilmington, North Carolina 28401-7307
Contact:
Hector Sanchez, Site 0392
910-815-6108

Southeastern Research Center
Winston-Salem, North Carolina 27103
Contact:
Reginald Fowler, Site 0325
336-659-8414

University of Cincinnati College Of Medicine
Cincinnati, Ohio 45267
Contact:
Nishant Gupta, Site 0419
513-558-4831

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
Maroun Matta, Site 0186
216-844-8447

The Ohio State University Wexner Medical Center
Columbus, Ohio 43201
Contact:
Derrick Herman, Site 0209
330-554-9628

Mercy St. Vincent Medical Center
Toledo, Ohio 43608-2603
Contact:
James Tita, Site 0343
419-251-4790

OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic
Oklahoma City, Oklahoma 73104-5417
Contact:
Jad Kebbe, Site 0198
405271617354612

Layrek Clinical Research
Tulsa, Oklahoma 74133
Contact:
Hassan Abouhouli, Site 0008
918-307-5490

Oregon Health & Science University - Pulmonary Clinic
Portland, Oregon 97239-3011
Contact:
Daniel Seifer, Site 0037
503-494-1620

Penn Medicine - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104-5161
Contact:
Mary Kreider, Site 0334

Spectrum Health Medical Group Pulmonary
Grand Rapids, Michigan 49546-8293
Contact:
Gayathri Sathiyamoorthy, Site 0050
616-267-9313

Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center
Philadelphia, Pennsylvania 19107-5109
Contact:
Ross Summer, Site 0348
215-955-5161

Temple University Hospital (TUH) - Temple Lung Center (TLC)
Philadelphia, Pennsylvania 19140-5103
Contact:
Gerard Criner, Site 0196
215-707-8113

Pulmonology Associates - Wynnewood
Wynnewood, Pennsylvania 19096
Contact:
Eliot Friedman, Site 0364
610-642-3796

Medical University of South Carolina- College of Medicine
Charleston, South Carolina 29425
Contact:
John Huggins, Site 0071
843-792-3162

Velocity Clinical Research - Durham
Greenville, South Carolina 29615
Contact:
Luis De La Cruz, Site 0373
864-770-0890

Vanderbilt Lung Institute - One Hundred Oaks
Nashville, Tennessee 37204
Contact:
Lisa Lancaster, Site 0363
615-948-8313

Baylor University Medical Center at Dallas
Dallas, Texas 75246
Contact:
Yolanda Mageto, Site 0317
802-847-4652

Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine
Houston, Texas 77030-4202
Contact:
Ivan Rosas, Site 0028
713-798-8842

McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location
Houston, Texas 77030
Contact:
Rodeo Abrencillo, Site 0041
713-500-6851

Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
Contact:
Shahrukh Kureishy, Site 0221
972-838-1892

University of Utah, University Hospital
Salt Lake City, Utah 84108
Contact:
Mary Beth Scholand, Site 0014
801-581-5811

VCU Medical Center
Richmond, Virginia 23298-5002
Contact:
Apostolos Perelas, Site 0414
215-760-2976

Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location
Everett, Washington 98208-6526
Contact:
Tomasz Ziedalski, Site 0190
425-252-1118

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Suha Kadura, Site 0043
206-823-4847

M Health Fairview University of Minnesota Medical Center - CSC - Center for Lung Science and Health
Minneapolis, Minnesota 55455-4800
Contact:
Hyun Kim, Site 0384
612-624-0999

University of Michigan Health System - A. Alfred Taubman Health Care Center - Pulmonary Clinic
Ann Arbor, Michigan 48109-5000
Contact:
Jamie Sheth, Site 0207

St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013-4220
Contact:
Rajat Walia, Site 0314
602-406-4000

St Francis Sleep Allergy & Lung Institute
Clearwater, Florida 33765
Contact:
Francis Averill, Site 0013
727-210-4606

University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic
Los Angeles, California 90033-5313
Contact:
Toby Maher, Site 0212
323-865-9854

David Geffen School of Medicine at UCLA
Los Angeles, California 90095-3075
Contact:
John Belperio, Site 0019
310-968-6324

UC Irvine Medical Center
Orange, California 92868-3201
Contact:
Huawei Dong, Site 0366
714-456-6776

University of California UC Davis Medical Center
Sacramento, California 95817
Contact:
Timothy Albertson, Site 0341
916-734-3650

University of California, San Francisco Medical Center- Pulmonary Practice
San Francisco, California 94143-2202
Contact:
Jeffrey Golden, Site 0015
415-353-2060

Stanford Hospital and Clinics
Stanford, California 94305
Contact:
Rishi Raj, Site 0352
650-725-8083

University of Colorado Anschutz Medical Campus - Department of Family Medicine
Aurora, Colorado 80045
Contact:
Joyce Lee, Site 0321
303-724-6109

National Jewish Health
Denver, Colorado 80206
Contact:
Michael Mohning, Site 0376
720-945-8608

Yale New Haven Hospital
New Haven, Connecticut 06510
Contact:
Mridu Gulati, Site 0211
203-785-4196

Stamford Health Medical Group - Stamford - 29 Hospital Plaza Suite 605
Stamford, Connecticut 06902-3602
Contact:
Caroline Gulati, Site 0418
203-785-2104

Christiana Care Pulmonary Associates - Newark
Newark, Delaware 19713-1337
Contact:
Renee Dixon, Site 0067
302-623-7600

Medstar Georgetown University Hospital
Washington, District of Columbia 20007-2113
Contact:
Cristina Reichner, Site 0354
202-444-0895

Meris Clinical Research
Brandon, Florida 33511-5706
Contact:
Rafael Martinez, Site 0195
813-413-7218

Florida Lung, Asthma and Sleep Specialists - Celebration
Celebration, Florida 34747-1818
Contact:
Fortune Alabi, Site 0380
877-352-5864

Omega Research Consultants LLC
DeBary, Florida 32713-1817
Contact:
Dany Obeid, Site 0396
386-668-4202

Steward St. Elizabeth Medical Center
Boston, Massachusetts 02135-2907
Contact:
Peter LaCamera, Site 0436
617-789-2545

Malcom Randall VA Medical Center
Gainesville, Florida 32608
Contact:
Faye Pais, Site 0036
35254860001076298

University of Florida (UF) Health Shands Hospital
Gainesville, Florida 32610
Contact:
Christopher Harden, Site 0193
352-284-5069

Pulmonary Specialists of the Palm Beaches
Loxahatchee Groves, Florida 33411
Contact:
Neal Warshoff, Site 0073
561-795-1022

Avanza Medical Research Center
Pensacola, Florida 32504
Contact:
Peter Bercz, Site 0452
850-477-7900

Coastal Pulmonary & Critical Care, P.L.C.
Saint Petersburg, Florida 33704
Contact:
Warren Abel, Site 0389
727-822-6661

Tampa General Hospital
Tampa, Florida 33601-1289
Contact:
Debabrata Bandyopadhyay, Site 0316
813-844-7137

Pulmonology, Sleep, Asthma & Allergy Center of Dublin
Dublin, Georgia 31021-2561
Contact:
Vishal Agrawal, Site 0368
478-272-3209

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Rade Tomic, Site 0435
312-695-1800

Loyola University Health System
Maywood, Illinois 60153-3328
Contact:
Daniel Dilling, Site 0082

University of Iowa Hospitals and Clinics
Iowa City, Iowa 522242-1009
Contact:
Nabeel Hamzeh, Site 0080
319-356-8343

University of Kansas Medical Center (KUMC)
Kansas City, Kansas 66103-2937
Contact:
Mark Hamblin, Site 0049

Norton Healthcare, Inc.
Louisville, Kentucky 40218-2497
Contact:
John McConnell, Site 0361
502-587-8000

University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland 21201-1544
Contact:
Edward Britt, Site 0305
410-328-8141

Massachusetts General Hospital
Boston, Massachusetts 02114-2621
Contact:
Barry Shea, Site 0404
617-643-7716

Alliance Pulmonary Group
Guaynabo, Puerto Rico 968
Contact:
Alvaro Aranda, Site 0214
7873978809

More Details

NCT ID
NCT06025578
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center