A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Summary

This study is open to adults aged 40 and older who have idiopathic pulmonary fibrosis (IPF). You may be eligible to join if you are either not receiving treatment for IPF or have been on stable treatment for at least 3 months prior to starting the study. The goal is to determine if a medicine called BI 1819479 can benefit people with IPF. Three different doses of BI 1819479 will be tested in the study.

If eligible, you will be randomly assigned to one of four groups. Three groups will receive varying doses of BI 1819479, while one group will receive placebo. The placebo tablets look like BI 1819479 but contain no active medicine. The treatment period lasts between 6 months to 1 year, and you will be involved in the study for up to 14 months. During this time, you will visit the study site 10 to 12 times and receive phone calls from the site staff.

At each visit, the study team will perform regular lung function tests to assess breathing capacity, comparing results between those taking BI 1819479 and the placebo. The study team will also monitor your overall health and document any side effects.

Eligibility

Currently recruiting participants: Yes

Eligible ages: 40 to 75

Inclusion criteria:

1 . 40 years old or older at the time of signed informed consent.
2. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
3. On stable treatment with nintedanib or pirfenidone for at least 12 weeks or not on treatment with either nintedanib or pirfenidone for at least 12 weeks

Exclusion criteria:

1. Under the age of 40.
2. Acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within at least 12 weeks prior to screening and/or during the screening period (investigator-determined).
3. Treated with immunosuppressive medications (other than oral corticosteroids) or prednisone >15 mg/day or equivalent for respiratory or pulmonary reasons.
4. Enrolled in another investigational device or drug trial.
5. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.

Participate

Fill out the following form if you want to participate in this research

Method of contact

Collection of personal information
Your personal information is collected under the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If you have any questions about the collection or use of this information, please visit our Access to Information page.

Additional information

Contact information

If you are interesting in participating in this study, contact the study coordinator, Madison Kong, at 403-210-7827.

Principal investigator:

Amanda Grant-Orser

Clinical trial:

Yes

REB-ID:

REB24-1369