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

Date Added
January 21st, 2024
PRO Number
Pro00132309
Researcher
John Huggins

List of Studies


Keywords
Interstitial Lung Disease (ILD), Pulmonary
Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study that will randomize participants with Progressive Pulmonary Fibrosis to study drug BMS-986278 60mg, 120mg, or Placebo, administered orally, twice a day. Participants are allowed to continue background therapy, such as antifibrotic and immunosuppressant therapies. This study will consist of two parts (Cohort 1 and 2). Cohort 1 will enroll approximately 60 participants with Progressive Pulmonary Fibrosis to evaluate the safety and tolerability of BMS-986278 in which participants will be randomized to receive 60 mg, 120mg, or placebo and this will last approximately 52 weeks. Cohort 2 is a registrational, double-blinded study which will investigate the efficacy, safety, and tolerability of BMS-986278 compared with placebo. Based on data from Cohort 1, the study will design 2 or 3 treatment arms for Cohort 2.

Institution
MUSC
Recruitment Contact
Robyn Empey
8437920965
recruitment@musc.edu

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

Date Added
January 17th, 2024
PRO Number
Pro00132221
Researcher
John Huggins

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The IM027068 Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study will randomize participants with IPF (Idiopathic Pulmonary Fibrosis) to BMS-986278- 60 mg or 120 mg, or placebo PO BID (orally, twice a day). 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 approximately 60 participants with IPF to evaluate the safety and tolerability of BMS-986278 in which participants will be randomized to receive 60 mg, 120mg, or placebo and this will last approximately 52 weeks. Cohort 2 is a registrational, double-blinded study which will investigate the efficacy, safety, and tolerability of BMS-986278 compared with placebo. Based on data from Cohort 1, the study will design 2 or 3 treatment arms for Cohort 2.

Institution
MUSC
Recruitment Contact
Robyn Empey
8437920965
recruitment@musc.edu



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