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Purpose

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

Condition

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

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

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

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

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

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

McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location
Houston, Texas 77030
Contact:
Rodeo Abrencillo, Site 0097
713-500-6829

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

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

Infectious Disease Associates Of NW Ohio Inc - Toledo
Toledo, Ohio 43608-2669
Contact:
James Tita, Site 0417
419-251-4790

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

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

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

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

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

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

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

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

OSF Saint Francis Medical Center
Peoria, Illinois 61637-0001
Contact:
Ossama Ikladios, Site 0325
309-672-5682

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

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

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

Renstar Medical Research
Ocala, Florida 34470
Contact:
Raj Karunakara, Site 0187
352-629-5800

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

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

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

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

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

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

National Jewish Health
Denver, Colorado 80206
Contact:
Michael Mohning, Site 0194
612-597-1224

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 Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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