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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2021230026

Enrollment

1185

Registered

2023-09-29

Start date

2023-10-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Experimental: BMS-986278 Dose 1 : BMS-986278 Specified dose on specified days Experimental: BMS-986278 Dose 2: BMS-986278 Specified dose on specified days Placebo Comparator: BMS-986278 Placebo: BM

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: History of stroke or transient ischemic attack within 3 months prior to screening Significant cardiac disease within 6 months prior to screening per the investigator's discretion 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. Note: Other protocol-defined inclusion/exclusion criteria apply

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in forced vital capacity (FVC) measured in mL [ Time Frame: At Week 52 ]	—

Secondary

Measure	Time frame
1.Disease progression [ Time Frame: Up to approximately 4 years ] 2.Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score [ Time Frame: At Week 52 and up to approximately 4 years ] 3.Change from baseline in L-PF dyspnea domain score [ Time Frame: At Week 52 and up to approximately 4 years ] etc.	—

Countries

Japan, US

Contacts

Public ContactYan Wang

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026