A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Trial end date: 2026-10-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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.