CompletedPhase 2

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

United States322 participantsStarted 2024-09-05

Plain-language summary

This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study. Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff. At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. Patients ≥40 years old at the time of signed informed consent.
✓. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
✓. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
✓. 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
✓. Forced Vital Capacity (FVC) ≥45% of predicted normal.
✓. Diffusion capacity of the lung for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb).
✓. Women of childbearing potential (WOCBP) must use highly effective methods of birth control with low user dependency and additional barrier contraception for male partners (use of condom) until end of follow-up period.
✓. Male trial participants with WOCBP partners must use contraception (condom) to avoid exposure via seminal fluid. Female partners of male trial participants must use highly effective methods of contraception during treatment until end of follow-up period.

Exclusion criteria

What they're measuring

Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year]

Timeframe: Up to 52 weeks

Trial details

NCT IDNCT06335303

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-25

View on ClinicalTrials.gov More Idiopathic Pulmonary Fibrosis trials