Study Details
BI 1015550: A Study Drug to Improve Lung Function in People with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
(IRB#: IRB_00158440)
Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) is a disease that causes lung function to be difficult such as breathing. BI 1015550 is a study drug to help people with PF-ILDs. Research is needed to know the safety, effectiveness, and side effects BI 1015550. The information we gain may aid future patients.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Diagnosis of progressive fibrosing ILD other than IPF
- Patients may be either: - On a stable therapy with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. - not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period and do not plan to start or re-start antifibrotic treatment.
- Childbearing-age participants must use birth control
Exclusion Criteria
- Acute ILD exacerbation (your disease declines suddenly and quickly) within 3 months prior to and/or during the screening period
- Human immunodeficiency virus (HIV) and viral hepatitis
- Patients who have developed Interstitial Lung Disease due to having COVID-19 within the past 12 months
- Major surgery within 6 weeks prior to or planned during the study, e.g. hip replacement. (Registration on lung transplantation list is not considered a planned major surgery.)
- Women who are pregnant, nursing, or who plan to become pregnant while in the study
Will I be paid for my time?
Yes
IRB#: IRB_00158440
PI: Mary Beth Scholand
Department: PULMONARY
Approval Date: 2023-02-08 07:00:00
Specialties: Pulmonary
I am Interested