IM0271015
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 Progressive Pulmonary Fibrosis.
IRAS ID
1008044
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 pulmonary fibrosis 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 idiopathic pulmonary fibrosis 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 IM0271015 Phase 3, multicenter, randomized, double-blind, PBO-controlled clinical study will randomize participants with PPF to BMS-986278 or PBO, by mouth route of administration twice daily (BID). Participants are allowed to continue background therapy, such as antifibrotic and immunosuppressive therapies. The study will utilize a 2-cohort design. Cohort 1 will enroll the first 60 participants with PPF 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 PPF. Cohort 2 will include up to 1032 participants.
Study population will be participants ≥ 21 years at the time of signing the informed consent. Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of disease on screening high-resolution computed tomography (HRCT).
Treatment period is approximately 3 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 3 years, depending on when the last participant completes the Week 52 visit). This period is inclusive of screening, treatment period and safety follow up.
REC name
West of Scotland REC 1
REC reference
24/WS/0028
Date of REC Opinion
9 Apr 2024
REC opinion
Further Information Favourable Opinion