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

Purpose

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

Condition

  • Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subjects with IPF aged ≥ 40 years at the time of signing the informed consent. - Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia. - 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. - 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

  • 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. - 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 0189
617-480-7076

Penn Medicine - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104-5161
Contact:
Mary Kreider, Site 0406

The Lung Research Center
Chesterfield, Missouri 63017-3425
Contact:
Neil Ettinger, Site 0096
314-682-3653

Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63110-1010
Contact:
Mary Clare McGregor, Site 0174
314-362-9919

Northern Westchester Hospital
Mount Kisco, New York 10549-3417
Contact:
Bushra Ayad Mina, Site 0154
212-794-2800

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Aparna Swaminathan, Site 0433
610-442-9029

Accellacare US Inc. of Wilmington
Wilmington, North Carolina 28401-7307
Contact:
Hector Sanchez, Site 0366
910-815-6108

Southeastern Research Center
Winston-Salem, North Carolina 27103
Contact:
Reginald Fowler, Site 0368
336-659-8414

University of Cincinnati College Of Medicine
Cincinnati, Ohio 45267-0595
Contact:
Nishant Gupta, Site 0201
513-558-4831

The Ohio State University Wexner Medical Center
Columbus, Ohio 43201
Contact:
Derrick Herman, Site 0197
330-554-9628

Mercy St. Vincent Medical Center
Toledo, Ohio 43608-2603
Contact:
James Tita, Site 0417
419-251-4790

OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic
Oklahoma City, Oklahoma 73104-5417
Contact:
Jad Kebbe, Site 0181
405271617354612

Layrek Clinical Research
Tulsa, Oklahoma 74133
Contact:
Hassan Abouhouli, Site 0373
918-307-5490

Oregon Health & Science University - Pulmonary Clinic
Portland, Oregon 97239-3011
Contact:
Daniel Seifer, Site 0021
503-494-1620

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033-2360
Contact:
Rebecca Bascom, Site 0067
717-531-2925

Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center
Philadelphia, Pennsylvania 19107-5109
Contact:
Ross Summer, Site 0388
215-955-5161

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Barry Shea, Site 0380
617-643-7716

Temple University Hospital (TUH) - Temple Lung Center (TLC)
Philadelphia, Pennsylvania 19140-5103
Contact:
Gerard Criner, Site 0199
215-707-8113

(UPMC) - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD)
Pittsburgh, Pennsylvania 15213
Contact:
Kevin Gibson, Site 0202
412-692-2149

Lankenau Medical Center
Wynnewood, Pennsylvania 19096-3432
Contact:
Eliot Friedman, Site 0346
610-642-3796

AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina 29621
Contact:
Abhijit Raval, Site 0375
423-741-6106

Medical University of South Carolina- College of Medicine
Charleston, South Carolina 29425
Contact:
John Huggins, Site 0188
843-792-3162

Vanderbilt Lung Institute - One Hundred Oaks
Nashville, Tennessee 37204
Contact:
Lisa Lancaster, Site 0400
615-948-8313

Baylor University Medical Center at Dallas
Dallas, Texas 75245-2017
Contact:
Yolanda Mageto, Site 0377
802-847-4652

Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine
Houston, Texas 77030-4202
Contact:
Ivan Rosas, Site 0039
713-798-8842

McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location
Houston, Texas 77030
Contact:
Rodeo Abrencillo, Site 0097
713-500-6851

Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
Contact:
Shahrukh Kureishy, Site 0029
972-838-1892

University of Utah, University Hospital
Salt Lake City, Utah 84108
Contact:
Mary Beth Scholand, Site 0027
801-581-5811

VCU Medical Center
Richmond, Virginia 23298
Contact:
Apostolos Perelas, Site 0184
215-760-2976

Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location
Everett, Washington 98208-6526
Contact:
Tomasz Ziedalski, Site 0191
425-252-1118

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Suha Kadura, Site 0362
206-823-4847

Steward St. Elizabeth Medical Center
Boston, Massachusetts 02135-2907
Contact:
Peter LaCamera, Site 0040
617-789-2545

University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland 21201-1544
Contact:
Edward Britt, Site 0354
410-328-8141

St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013-4220
Contact:
Rajat Walia, Site 0361
602-406-4000

Omega Research Consultants LLC
DeBary, Florida 32713-1817
Contact:
Dany Obeid, Site 0425
386-668-4202

University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic
Los Angeles, California 90033-5313
Contact:
Toby Maher, Site 0193
323-865-9854

David Geffen School of Medicine at UCLA
Los Angeles, California 90095-3075
Contact:
John Belperio, Site 0398
310-968-6324

UC Irvine Medical Center
Orange, California 92868-3201
Contact:
Huawei Dong, Site 0389
714-456-6776

University of California UC Davis Medical Center
Sacramento, California 95817
Contact:
Timothy Albertson, Site 0405
916-734-3650

University of California, San Francisco Medical Center- Pulmonary Practice
San Francisco, California 94143-2202
Contact:
Jeffrey Golden, Site 0185
415-353-2060

Stanford University School of Medicine
Stanford, California 94305
Contact:
Rishi Raj, Site 0186
650-725-8083

University of Colorado Anschutz Medical Campus - Department of Family Medicine
Aurora, Colorado 80045
Contact:
Joyce Lee, Site 0363
303-724-6109

National Jewish Health
Denver, Colorado 80206
Contact:
Michael Mohning, Site 0194
720-945-8608

Yale New Haven Hospital
New Haven, Connecticut 06510
Contact:
Mridu Gulati, Site 0175
203-785-4196

Christiana Care Pulmonary Associates - Newark
Newark, Delaware 19713-1337
Contact:
Renee Dixon, Site 0151
302-623-7600

Medstar Georgetown University Hospital
Washington, District of Columbia 20007-2113
Contact:
Cristina Reichner, Site 0367
202-444-0895

Meris Clinical Research
Brandon, Florida 33511-5706
Contact:
Rafael Martinez, Site 0101
813-413-7218

St Francis Sleep Allergy & Lung Institute
Clearwater, Florida 33765
Contact:
Francis Averill, Site 0436
727-210-4606

University of Florida (UF) Health Shands Hospital
Gainesville, Florida 32610
Contact:
Christopher Harden, Site 0079
352-284-5069

Norton Pulmonary Specialists
Louisville, Kentucky 40202-1332
Contact:
John McConnell, Site 0393
502-587-8000

Harmony Medical Research Institute, Inc
Hialeah, Florida 33016
Contact:
Juan Fernandez, Site 0352

Clinical Research Specialists, LLC - Kissimmee
Kissimmee, Florida 34746-4654
Contact:
Fortune Alabi, Site 0370
877-352-5864

Pulmonary Specialists of the Palm Beaches
Loxahatchee Groves, Florida 33411
Contact:
Neal Warshoff, Site 0153
561-795-1022

Renstar Medical Research
Ocala, Florida 34471
Contact:
Raj Karunakara, Site 0187
352-629-5800

Avanza Medical Research Center
Pensacola, Florida 32503-2670
Contact:
Peter Bercz, Site 0418
850-477-7900

Coastal Pulmonary & Critical Care, P.L.C.
Saint Petersburg, Florida 33704
Contact:
Warren Abel, Site 0206
727-822-6661

University of South Florida
Tampa, Florida 33606
Contact:
Debabrata Bandyopadhyay, Site 0364
813-844-7137

Pulmonology, Sleep, Asthma & Allergy Center of Dublin
Dublin, Georgia 31021-2561
Contact:
Vishal Agrawal, Site 0372
478-272-3209

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Rade Tomic, Site 0178
312-695-1800

Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building
Chicago, Illinois 60612-3841
Contact:
Xiaoping Wu, Site 0183
312-942-5873

Loyola University Health System
Maywood, Illinois 60153-3328
Contact:
Daniel Dilling, Site 0085

Illinois Lung & Critical Care Institute
Peoria, Illinois 61637-0001
Contact:
Ossama Ikladios, Site 0325
309-672-5682

University of Iowa Hospitals and Clinics
Iowa City, Iowa 522242-1009
Contact:
Nabeel Hamzeh, Site 0180
319-356-8343

University of Kansas Medical Center (KUMC)
Kansas City, Kansas 66160
Contact:
Mark Hamblin, Site 0204

Alliance Pulmonary Group
Guaynabo, Puerto Rico 968
Contact:
Alvaro Aranda, Site 0198
7873978809

More Details

NCT ID
NCT06003426
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