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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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

Key facts

Study ID

NCT06003426

Run by

Bristol-Myers Squibb

People needed

1255

Starts

2023-09-14

Expected to finish

2027-06-04

Last updated by the study team

2026-03-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations.
• Other protocol-defined Inclusion/Exclusion criteria apply

Where it is running

• Local Institution - 0321 — Brest, France
• Local Institution - 0052 — Dijon, France
• Local Institution - 0022 — Paris, France
• Local Institution - 0342 — Pessac, France
• Local Institution - 0023 — Toulouse, France
• Local Institution - 0339 — Tours, France
• Local Institution - 0126 — Forlì, Italy
• Local Institution - 0069 — Milan, Italy
• Local Institution - 0121 — Monza, Italy
• Local Institution - 0323 — Naples, Italy
• Local Institution - 0125 — Palermo, Italy
• Local Institution - 0122 — Pavia, Italy
• Local Institution - 0120 — Sassari, Italy
• Local Institution - 0114 — Siena, Italy
• Local Institution - 0107 — Chiba, Chiba, Japan
• Local Institution - 0224 — Jongno-gu, Seoul, South Korea
• Local Institution - 0276 — Yongsan-gu, Seoul, South Korea
• Local Institution - 0441 — Dong-gu, Ulsan, South Korea
• Local Institution - 0404 — Bucheon-si, South Korea
• Local Institution - 0227 — Bucheonsi Weonmigu, South Korea
• Local Institution - 0440 — Busan, South Korea
• Local Institution - 0284 — Donggu, South Korea
• Local Institution - 0250 — Gyeonggi-do, South Korea
• Local Institution - 0231 — Haeundae-Gu, South Korea
• Local Institution - 0066 — Bobigny, France

Full record on ClinicalTrials.gov

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