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
Medstar Georgetown University Hospital
Washington, District of Columbia 20007-2113
Washington, District of Columbia 20007-2113
Contact:
Cristina Reichner, Site 0367
202-444-0895
Cristina Reichner, Site 0367
202-444-0895
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Study Connect Contact Center www.BMSStudyConnect.com855-907-3286
Clinical.Trials@bms.com