BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with idiopathic pulmonary fibrosis.
- Study Sponsor: Bristol-Myers Squibb
- Start Date: September 2023
- Estimated Primary Completion Date: October 2026
- Phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with idiopathic pulmonary fibrosis.
Primary Outcome Measure:
- Cohort 1: Number of participants that experience spontaneous syncopal events [Timeframe: at approximately 4 weeks]
- Cohort 2: Absolute change from baseline in forced vital capacity (FVC) measured in mL [Timeframe: at Week 52]
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.