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
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 0189
617-480-7076
Philadelphia, Pennsylvania 19107-5109
Ross Summer, Site 0388
215-955-5161
Chesterfield, Missouri 63017-3425
Neil Ettinger, Site 0096
314-682-3653
Saint Louis, Missouri 63110-1010
Mary Clare McGregor, Site 0174
314-362-9919
Mount Kisco, New York 10549-3417
Bushra Ayad Mina, Site 0154
212-794-2800
Durham, North Carolina 27710
Aparna Swaminathan, Site 0433
610-442-9029
Wilmington, North Carolina 28401-7307
Hector Sanchez, Site 0366
910-815-6108
Winston-Salem, North Carolina 27103
Reginald Fowler, Site 0368
336-659-8414
Cincinnati, Ohio 45267-0595
Nishant Gupta, Site 0201
513-558-4831
Columbus, Ohio 43201
Derrick Herman, Site 0197
330-554-9628
Toledo, Ohio 43608-2603
James Tita, Site 0417
419-251-4790
Oklahoma City, Oklahoma 73104-5417
Jad Kebbe, Site 0181
405271617354612
Tulsa, Oklahoma 74133
Hassan Abouhouli, Site 0373
918-307-5490
Portland, Oregon 97239-3011
Daniel Seifer, Site 0021
503-494-1620
Hershey, Pennsylvania 17033-2360
Rebecca Bascom, Site 0067
717-531-2925
Philadelphia, Pennsylvania 19104-5161
Mary Kreider, Site 0406
Philadelphia, Pennsylvania 19140-5103
Gerard Criner, Site 0199
215-707-8113
Boston, Massachusetts 02135-2907
Peter LaCamera, Site 0040
617-789-2545
Pittsburgh, Pennsylvania 15213
Kevin Gibson, Site 0202
412-692-2149
Wynnewood, Pennsylvania 19096-3432
Eliot Friedman, Site 0346
610-642-3796
Anderson, South Carolina 29621
Abhijit Raval, Site 0375
423-741-6106
Charleston, South Carolina 29425
John Huggins, Site 0188
843-792-3162
Nashville, Tennessee 37204
Lisa Lancaster, Site 0400
615-948-8313
Dallas, Texas 75245-2017
Yolanda Mageto, Site 0377
802-847-4652
Houston, Texas 77030-4202
Ivan Rosas, Site 0039
713-798-8842
Houston, Texas 77030
Rodeo Abrencillo, Site 0097
713-500-6851
McKinney, Texas 75069
Shahrukh Kureishy, Site 0029
972-838-1892
San Antonio, Texas 78229-4404
Dean Kellogg, Site 0048
210-617-5256
Salt Lake City, Utah 84108
Mary Beth Scholand, Site 0027
801-581-5811
Richmond, Virginia 23298
Apostolos Perelas, Site 0184
215-760-2976
Everett, Washington 98208-6526
Tomasz Ziedalski, Site 0191
425-252-1118
Seattle, Washington 98195
Suha Kadura, Site 0362
206-823-4847
Ann Arbor, Michigan 48109-5000
Jamie Sheth, Site 0472
Boston, Massachusetts 02114
Barry Shea, Site 0380
617-643-7716
Phoenix, Arizona 85013-4220
Rajat Walia, Site 0361
602-406-4000
DeBary, Florida 32713-1817
Dany Obeid, Site 0425
386-668-4202
La Jolla, California 92037-1027
Jacqueline Chang, Site 0396
858-824-5404
Los Angeles, California 90033-5313
Toby Maher, Site 0193
323-865-9854
Los Angeles, California 90095-3075
John Belperio, Site 0398
310-968-6324
Orange, California 92868-3201
Huawei Dong, Site 0389
714-456-6776
Sacramento, California 95817
Timothy Albertson, Site 0405
916-734-3650
San Francisco, California 94143-2202
Jeffrey Golden, Site 0185
415-353-2060
Stanford, California 94305
Rishi Raj, Site 0186
650-725-8083
Aurora, Colorado 80045
Joyce Lee, Site 0363
303-724-6109
Denver, Colorado 80206
Michael Mohning, Site 0194
720-945-8608
New Haven, Connecticut 06510
Mridu Gulati, Site 0175
203-785-4196
Newark, Delaware 19713-1337
Renee Dixon, Site 0151
302-623-7600
Washington, District of Columbia 20007-2113
Cristina Reichner, Site 0367
202-444-0895
Brandon, Florida 33511-5706
Rafael Martinez, Site 0101
813-413-7218
Clearwater, Florida 33765
Francis Averill, Site 0436
727-210-4606
Gainesville, Florida 32610
Christopher Harden, Site 0079
352-284-5069
Baltimore, Maryland 21201-1544
Edward Britt, Site 0354
410-328-8141
Chicago, Illinois 60611
Rade Tomic, Site 0178
312-695-1800
Louisville, Kentucky 40202-1332
John McConnell, Site 0393
502-587-8000
Kansas City, Kansas 66160
Mark Hamblin, Site 0204
Iowa City, Iowa 522242-1009
Nabeel Hamzeh, Site 0180
319-356-8343
Peoria, Illinois 61637-0001
Ossama Ikladios, Site 0325
309-672-5682
Maywood, Illinois 60153-3328
Daniel Dilling, Site 0085
Chicago, Illinois 60612-3841
Xiaoping Wu, Site 0183
312-942-5873
Dublin, Georgia 31021-2561
Vishal Agrawal, Site 0372
478-272-3209
Hialeah, Florida 33016
Juan Fernandez, Site 0352
Tampa, Florida 33606
Debabrata Bandyopadhyay, Site 0364
813-844-7137
Saint Petersburg, Florida 33704
Warren Abel, Site 0206
727-822-6661
Pensacola, Florida 32503-2670
Peter Bercz, Site 0418
850-477-7900
Ocala, Florida 34471
Raj Karunakara, Site 0187
352-629-5800
Loxahatchee Groves, Florida 33411
Neal Warshoff, Site 0153
561-795-1022
Kissimmee, Florida 34746-4654
Fortune Alabi, Site 0370
877-352-5864
Guaynabo, Puerto Rico 968
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.com855-907-3286
Clinical.Trials@bms.com