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

JRCT ID: jRCT2021230026

Registered date:29/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Idiopathic Pulmonary Fibrosis
• Date of first enrollment: 26/10/2023
• Target sample size: 1185
• Countries of recruitment: US,Japan
• Study type: Interventional

Intervention(s)

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: BMS-986278 Placebo
Specified dose on specified days

Outcome(s)

• Primary Outcome: Absolute change from baseline in forced vital capacity (FVC) measured in mL [ Time Frame: At Week 52 ]

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Wang Yan