A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
Purpose
The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.
Condition
- Pulmonary Fibrosis
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
For the idiopathic pulmonary fibrosis (IPF) Cohort - Diagnosis of IPF within 7 years of screening - Female and males ≥ 40 years of age For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort - Evidence of progressive ILD within the 24 months before screening - Female and male ≥ 21 years of age.
Exclusion Criteria
- Women of childbearing potential (WOCBP) - Active Smokers - Current malignancy or previous malignancy up to 5 years prior to screening - History of allergy to BMS-986278 or related compounds Other protocol-defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IPF Dose 1 + Post Treatment Follow-up or OTE |
IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension) |
|
|
Experimental IPF Dose 2 + Post Treatment Follow-up or OTE |
|
|
|
Placebo Comparator IPF Placebo + Post Treatment Follow-up or OTE |
|
|
|
Experimental PF-ILD Dose 1 + Post Treatment Follow-up or OTE |
PF-ILD (Progressive Fibrotic Interstitial Lung Disease) |
|
|
Experimental PF-ILD Dose 2 + Post Treatment Follow-up or OTE |
|
|
|
Placebo Comparator PF-ILD Placebo + Post Treatment Follow-up or OTE |
|
More Details
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb