A study to find out whether BI 1015550 improves lung functionin people with Progressive Fibrosing Interstitial Lung Diseases(PF-ILDs)
- Conditions
- Progressive Fibrosing Interstitial Lung Diseases
- Registration Number
- JPRN-jRCT2031220475
- Lead Sponsor
- Yamamoto Akiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1041
Patients 18 years old and older at the time of signed consent
-Progressive fibrosing ILD other than IPF based on predefined criteria
-Forced Vital Capacity (FVC) 45% and grater of predicted normal
-Diffusing Capacity for Carbon Monoxide (DLCO) 25% and grater and less than 90% predicted of normall
-On stable treatment with nintedanib for at least 12 weeks or not on treatment with nintedanib for at least 8 weeks
-Relevant airways obstruction (prebronchodilator FEV1/FVC less than 0.7)
-Acute ILD exacerbation within 3 months and/or during the screening period
-Treated with prednisone more than15 mg/day or equivalent within 4 weeks; cyclophosphamide, tocilizumab, mycophenolate, pirfenidone within 8 weeks; rituximab within 6 months
-Active, unstable or uncontrolled vasculitis within 8 weeks
-Any suicidal behavior in the past 2 years
-Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method