Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis (IM027-040)
Phase 2
Completed
- Conditions
- Pulmonary Fibrosis
- Registration Number
- jRCT2080225297
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
IPF Cohort: -Diagnosis of IPF within 7 years ->=40 years of age PF-ILD Cohort: -Evidence of progressive ILD within 24 months ->= 21 years of age
Exclusion Criteria
-Women who are of childbearing potential -Smokers
- Concurrent malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Randomized, double-blind clinical trial
- Primary Outcome Measures
Name Time Method - efficacy
- Secondary Outcome Measures
Name Time Method Evaluate AEs, SAEs, laboratory test results, etc. as safety 26 weeks Evaluate AEs, SAEs, laboratory test results, etc. as safety
Evaluate the percent change in ppFCV in PF-ILD subjects 26 weeks Evaluate the percent change in ppFCV in PF-ILD subjects
Evaluate PK parameters including Cmax, Tmax, and AUC of BMS-986278 Day1 and Week 4 Evaluate PK parameters including Cmax, Tmax, and AUC of BMS-986278
Trial Locations
- Locations (1)
Japan/Asia except Japan/North America/South America/Europe/Oceania
Location not specified
Japan/Asia except Japan/North America/South America/Europe/Oceania