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 Sex
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; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations. - 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 4049979, Alabama 4829764 35294
Contact:
Tejaswini Kulkarni, Site 0046
617-480-7076

St. Joseph's Hospital and Medical Center
Phoenix 5308655, Arizona 5551752 85013-4220
Contact:
Rajat Walia, Site 0314
602-406-4000

Scripps Clinic Torrey Pines
La Jolla 5363943, California 5332921 92037-1027
Contact:
Jacqueline Chang, Site 0336
858-824-5404

University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic
Los Angeles 5368361, California 5332921 90033-5313
Contact:
Toby Maher, Site 0212
323-865-9854

David Geffen School of Medicine at UCLA
Los Angeles 5368361, California 5332921 90095-3075
Contact:
John Belperio, Site 0019
310-968-6324

UC Irvine Medical Center
Orange 5379513, California 5332921 92868-3201
Contact:
Huawei Dong, Site 0366
714-456-6776

University of California UC Davis Medical Center
Sacramento 5389489, California 5332921 95817
Contact:
Timothy Albertson, Site 0341
916-734-3650

University of California, San Francisco Medical Center- Pulmonary Practice
San Francisco 5391959, California 5332921 94143-2202
Contact:
Jeffrey Golden, Site 0015
415-353-2060

Stanford Hospital and Clinics
Stanford 5398563, California 5332921 94305
Contact:
Rishi Raj, Site 0352
650-725-8083

University of Colorado Anschutz Medical Campus - Department of Family Medicine
Aurora 5412347, Colorado 5417618 80045
Contact:
Joyce Lee, Site 0321
303-724-6109

National Jewish Health
Denver 5419384, Colorado 5417618 80206
Contact:
Michael Mohning, Site 0376
720-945-8608

Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06510
Contact:
Mridu Gulati, Site 0211
203-785-4196

Stamford Health Medical Group - Stamford - 29 Hospital Plaza Suite 605
Stamford 4843564, Connecticut 4831725 06904
Contact:
Caroline Gulati, Site 0418
203-785-2104

Christiana Care Pulmonary Associates - Newark
Newark 4143861, Delaware 4142224 19713-1337
Contact:
Renee Dixon, Site 0067
302-623-7600

Medstar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007-2113
Contact:
Cristina Reichner, Site 0354
202-444-0895

Meris Clinical Research
Brandon 4148757, Florida 4155751 33511-5706
Contact:
Rafael Martinez, Site 0195
813-413-7218

Florida Lung, Asthma and Sleep Specialists - Celebration
Celebration 4150394, Florida 4155751 34747-1818
Contact:
Fortune Alabi, Site 0380
877-352-5864

St Francis Sleep Allergy & Lung Institute
Clearwater 4151316, Florida 4155751 33765
Contact:
Francis Averill, Site 0013
727-210-4606

Omega Research Consultants LLC
DeBary 4152926, Florida 4155751 32713-1817
Contact:
Kwabena Ayesu, Site 0396
386-668-4202

Malcom Randall VA Medical Center
Gainesville 4156404, Florida 4155751 32608
Contact:
Faye Pais, Site 0036
35254860001076298

University of Florida (UF) Health Shands Hospital
Gainesville 4156404, Florida 4155751 32610
Contact:
Christopher Harden, Site 0193
352-284-5069

Pulmonary Specialists of the Palm Beaches
Loxahatchee Groves 4162948, Florida 4155751 33411
Contact:
Neal Warshoff, Site 0073
561-795-1022

Avanza Medical Research Center
Pensacola 4168228, Florida 4155751 32503
Contact:
Peter Bercz, Site 0452
850-477-7900

Coastal Pulmonary & Critical Care, P.L.C.
St. Petersburg 4171563, Florida 4155751 33704
Contact:
Warren Abel, Site 0389
727-822-6661

Tampa General Hospital
Tampa 4174757, Florida 4155751 33601-1289
Contact:
Debabrata Bandyopadhyay, Site 0316
813-844-7137

Emory Clinic
Atlanta 4180439, Georgia 4197000 30322-1013
Contact:
Srihari Veeraraghavan, Site 0070
404-778-5736

Pulmonology, Sleep, Asthma & Allergy Center of Dublin
Dublin 4192205, Georgia 4197000 31021-2561
Contact:
Vishal Agrawal, Site 0368
478-272-3209

Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
Contact:
Bradford Bemiss, Site 0435
708-216-0160

The University of Chicago Medicine
Chicago 4887398, Illinois 4896861 60637-1447
Contact:
Ayodeji Adegunsoye, Site 0023
205-585-9948

Loyola University Health System
Maywood 4901514, Illinois 4896861 60153-3328
Contact:
Daniel Dilling, Site 0082

University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 522242-1009
Contact:
Nabeel Hamzeh, Site 0080
319-356-8343

University of Kansas Medical Center (KUMC)
Kansas City 4273837, Kansas 4273857 66103-2937
Contact:
Mark Hamblin, Site 0049

Norton Healthcare, Inc.
Louisville 4299276, Kentucky 6254925 40218-2497
Contact:
John McConnell, Site 0361
502-587-8000

University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore 4347778, Maryland 4361885 21201-1544
Contact:
Edward Britt, Site 0305
410-328-8141

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114-2621
Contact:
Barry Shea, Site 0404
617-726-1721

University of Michigan Health System - A. Alfred Taubman Health Care Center - Pulmonary Clinic
Ann Arbor 4984247, Michigan 5001836 48109-5000
Contact:
Jamie Sheth, Site 0207

Spectrum Health Medical Group Pulmonary
Grand Rapids 4994358, Michigan 5001836 49546-8293
Contact:
Gayathri Sathiyamoorthy, Site 0050
616-267-9313

M Health Fairview University of Minnesota Medical Center - CSC - Center for Lung Science and Health
Minneapolis 5037649, Minnesota 5037779 55455-4800
Contact:
Hyun Kim, Site 0384
612-624-0999

The Lung Research Center
Chesterfield 4381072, Missouri 4398678 63017
Contact:
Neil Ettinger, Site 0004
314-682-3653

Washington University School of Medicine in St. Louis
St Louis 4407066, Missouri 4398678 63110-1010
Contact:
Mary Clare McGregor, Site 0223
314-362-9919

Renown Regional Medical Center
Reno 5511077, Nevada 5509151 89502-1576
Contact:
Farah Kassamali Madhani-Lovely, Site 0525
775-982-4100

Northern Westchester Hospital
Mount Kisco 5127744, New York 5128638 10549-3417
Contact:
Bushra Ayad Mina, Site 0068
212-794-2800

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029-6574
Contact:
Maria Padilla, Site 0357
212-241-5656

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Contact:
Aparna Swaminathan, Site 0428
610-442-9029

Accellacare US Inc. of Wilmington
Wilmington 4499379, North Carolina 4482348 28401-7307
Contact:
Hector Sanchez, Site 0392
910-815-6108

Southeastern Research Center
Winston-Salem 4499612, North Carolina 4482348 27103
Contact:
Reginald Fowler, Site 0325
336-659-8414

University of Cincinnati College Of Medicine
Cincinnati 4508722, Ohio 5165418 45267
Contact:
Nishant Gupta, Site 0419
513-558-4831

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Maroun Matta, Site 0186
216-844-8447

The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43201
Contact:
Derrick Herman, Site 0209
330-554-9628

Mercy St. Vincent Medical Center
Toledo 5174035, Ohio 5165418 43608-2603
Contact:
Vinod Khatri, Site 0343
419-251-4919

OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic
Oklahoma City 4544349, Oklahoma 4544379 73104-5417
Contact:
Jad Kebbe, Site 0198
405271617354612

Layrek Clinical Research
Tulsa 4553433, Oklahoma 4544379 74133
Contact:
Hassan Abouhouli, Site 0008
918-307-5490

Oregon Health & Science University - Pulmonary Clinic
Portland 5746545, Oregon 5744337 97239-3011
Contact:
Daniel Seifer, Site 0037
503-494-1620

Penn State Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033-2360
Contact:
Rebecca Bascom, Site 0205
717-531-2925

Penn Medicine - Perelman Center for Advanced Medicine
Philadelphia 4560349, Pennsylvania 6254927 19104-5161
Contact:
Kathryn Flack, Site 0334

Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center
Philadelphia 4560349, Pennsylvania 6254927 19107-5109
Contact:
Ross Summer, Site 0348
215-955-5161

Temple University Hospital (TUH) - Temple Lung Center (TLC)
Philadelphia 4560349, Pennsylvania 6254927 19140-5103
Contact:
Gerard Criner, Site 0196
215-707-8113

Pulmonology Associates - Wynnewood
Wynnewood 5220230, Pennsylvania 6254927 19096
Contact:
Eliot Friedman, Site 0364
610-642-3796

AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine
Anderson 4569298, South Carolina 4597040 29621
Contact:
Abhijit Raval, Site 0531
423-741-6106

Medical University of South Carolina- College of Medicine
Charleston 4574324, South Carolina 4597040 29425
Contact:
Timothy Whelan, Site 0071
843-792-3167

Velocity Clinical Research Inc.
Greenville 4580543, South Carolina 4597040 29615
Contact:
Luis De La Cruz, Site 0373
864-770-0890

Vanderbilt Lung Institute - One Hundred Oaks
Nashville 4644585, Tennessee 4662168 37204
Contact:
Margaret Salisbury, Site 0363
314-608-6188

University of Texas Southwestern Medical Center - Pulmonary Specialty Clinic
Dallas 4684888, Texas 4736286 75235-5351
Contact:
Corey Kershaw, Site 0024
214-645-7108

Baylor University Medical Center at Dallas
Dallas 4684888, Texas 4736286 75246
Contact:
Yolanda Mageto, Site 0317
000-000-0000

Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine
Houston 4699066, Texas 4736286 77030-4202
Contact:
Ivan Rosas, Site 0028
713-798-8842

McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location
Houston 4699066, Texas 4736286 77030
Contact:
Rodeo Abrencillo, Site 0041
713-500-6851

Metroplex Pulmonary and Sleep Center
McKinney 4710178, Texas 4736286 75069
Contact:
Shahrukh Kureishy, Site 0221
972-838-1892

South Texas Veterans Health Care System - Audie L. Murphy VA Hospital
San Antonio 4726206, Texas 4736286 78229-4404
Contact:
Anoop Nambiar, Site 0217

University of Utah, University Hospital
Salt Lake City 5780993, Utah 5549030 84108
Contact:
Mary Beth Scholand, Site 0014
801-581-5811

The University of Vermont
Burlington 5234372, Vermont 5242283 05401
Contact:
Ena Gupta, Site 0504
802-847-1158

VCU Medical Center
Richmond 4781708, Virginia 6254928 23298-5002
Contact:
Apostolos Perelas, Site 0414
215-760-2976

Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location
Everett 5793933, Washington 5815135 98208-6526
Contact:
Tomasz Ziedalski, Site 0190
425-252-1118

University of Washington Medical Center
Seattle 5809844, Washington 5815135 98195
Contact:
Chi Hung, Site 0043
206-897-5377

Alliance Pulmonary Group
Guaynabo 4565119, PR, 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