IM027068
Research type
Research Study
Full title
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.
IRAS ID
1008043
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Research summary
There remains a large unmet need for a safe, well-tolerated and effective therapy for idiopathic pulmonary fibrosis (IPF) that improves pulmonary function, delays disease progression, and reduces mortality. BMS-986278, a lysophosphatidic acid receptor 1 antagonist, is an orally administered investigational product being developed for the treatment of patients with IPF and progressive pulmonary fibrosis (PPF). A Phase 2 study in participants with lung fibrosis (Study IM027040) has shown favorable safety and efficacy with BMS-986278 as monotherapy and in participants on antifibrotic therapy.
The IM027068 Phase 3, multicenter, randomized, double-blind, PBO-controlled clinical study will randomize participants with IPF to BMS-986278 or PBO, PO BID. Participants are allowed to continue antifibrotic therapy for IPF with nintedanib or pirfenidone. The study will utilize a 2-cohort design. Cohort 1 will enroll the first 60 participants with IPF to allow an unblinded review committee to assess safety before opening Cohort 2. Cohort 2 will investigate the efficacy, safety, and tolerability of BMS-986278 in participants with IPF. Cohort 2 will include approximately 1125 participants.
Participants with IPF aged ≥ 40 years at the time of signing the informed consent form with a 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.
Treatment period is approximately 4 years from the Day 1 visit for the first randomized participant through the last participant’s end of treatment (a participant’s individual study duration could be from a minimum of 52 weeks up to approximately 4 years, depending on when the last participant completes the Week 52 visit).
Study intervention consists of blinded IMP of either BMS-986278 or PBO BID.REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0695
Date of REC Opinion
2 Nov 2023
REC opinion
Further Information Favourable Opinion