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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental BMS-986278 Dose 1 |
|
|
Experimental BMS-986278 Dose 2 |
|
|
Placebo Comparator BMS-986278 Placebo |
|
Recruiting Locations
Birmingham, Alabama 35294
Tejaswini Kulkarni, Site 0046
617-480-7076
Hershey, Pennsylvania 17033-2360
Rebecca Bascom, Site 0205
717-531-2925
Mount Kisco, New York 10549-3417
Bushra Ayad Mina, Site 0068
212-794-2800
New York, New York 10029-6574
Maria Padilla, Site 0357
212-241-5656
Durham, North Carolina 27710
Aparna Swaminathan, Site 0428
610-442-9029
Wilmington, North Carolina 28401-7307
Hector Sanchez, Site 0392
910-815-6108
Winston-Salem, North Carolina 27103
Reginald Fowler, Site 0325
336-659-8414
Cleveland, Ohio 44106
Maroun Matta, Site 0186
216-844-8447
Columbus, Ohio 43201
Derrick Herman, Site 0209
330-554-9628
Toledo, Ohio 43608-2603
James Tita, Site 0343
419-251-4790
Tulsa, Oklahoma 74133
Hassan Abouhouli, Site 0008
918-307-5490
Portland, Oregon 97239-3011
Daniel Seifer, Site 0037
503-494-1620
Philadelphia, Pennsylvania 19107-5109
Rafael Perez, Site 0348
215-955-8855
Chesterfield, Missouri 63017
Neil Ettinger, Site 0004
314-682-3653
Philadelphia, Pennsylvania 19140-5103
Gerard Criner, Site 0196
215-707-8113
Wynnewood, Pennsylvania 19096
Eliot Friedman, Site 0364
610-642-3796
Charleston, South Carolina 29425
John Huggins, Site 0071
843-792-3162
Dallas, Texas 75246
Yolanda Mageto, Site 0317
802-847-4652
Houston, Texas 77030
Rodeo Abrencillo, Site 0041
713-500-6829
McKinney, Texas 75069
Shahrukh Kureishy, Site 0221
972-838-1892
Salt Lake City, Utah 84108
Mary Beth Scholand, Site 0014
801-581-5811
Richmond, Virginia 23298-5002
Apostolos Perelas, Site 0414
215-760-2976
Everett, Washington 98208-6526
Tomasz Ziedalski, Site 0190
425-252-1118
Seattle, Washington 98195
Lawrence Ho, Site 0043
Saint Louis, Missouri 63110-1010
Mary Clare McGregor, Site 0223
314-362-9919
Minneapolis, Minnesota 55455-4800
Hyun Kim, Site 0384
612-624-0999
Orange, California 92868-3201
Huawei Dong, Site 0366
714-456-6776
Clearwater, Florida 33765
Francis Averill, Site 0013
727-210-4606
Sacramento, California 95817
Timothy Albertson, Site 0341
916-734-3650
San Francisco, California 94143-2202
Jeffrey Golden, Site 0015
415-353-2060
Stanford, California 94305
Rishi Raj, Site 0352
650-725-8083
Aurora, Colorado 80045
Joyce Lee, Site 0321
303-724-6109
Denver, Colorado 80206
Michael Mohning, Site 0376
720-945-8608
New Haven, Connecticut 06510
Mridu Gulati, Site 0211
203-785-4196
Stamford, Connecticut 06902-3602
Caroline Gulati, Site 0418
203-785-2104
Washington, District of Columbia 20007-2113
Cristina Reichner, Site 0354
202-444-0895
Brandon, Florida 33511-5706
Rafael Martinez, Site 0195
813-413-7218
Celebration, Florida 34747-1818
Fortune Alabi, Site 0380
877-352-5864
DeBary, Florida 32713-1817
Dany Obeid, Site 0396
386-668-4202
Ann Arbor, Michigan 48109-5000
Jamie Sheth, Site 0207
Gainesville, Florida 32610
Christopher Harden, Site 0193
352-284-5069
Loxahatchee Groves, Florida 33411
Neal Warshoff, Site 0073
561-795-1022
Pensacola, Florida 32504
Peter Bercz, Site 0452
850-477-7900
Saint Petersburg, Florida 33704
Warren Abel, Site 0389
727-822-6661
Dublin, Georgia 31021-2561
Vishal Agrawal, Site 0368
478-272-3209
Iowa City, Iowa 522242-1009
Nabeel Hamzeh, Site 0080
319-356-8343
Kansas City, Kansas 66103-2937
Mark Hamblin, Site 0049
Louisville, Kentucky 40218-2497
John McConnell, Site 0361
502-587-8000
Baltimore, Maryland 21201-1544
Edward Britt, Site 0305
410-328-8141
Boston, Massachusetts 02114-3108
Barry Shea, Site 0404
617-643-7716
Boston, Massachusetts 02135-2907
Peter LaCamera, Site 0436
617-789-2545
Guaynabo, Puerto Rico 968
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.com855-907-3286
Clinical.Trials@bms.com