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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
322
BI 1819479
Placebo matching BI 1819479
University of Alabama at Birmingham
Birmingham, Alabama, United States
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado, United States
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, United States
SEC Clinical Research
Pensacola, Florida, United States
The Iowa Clinic, PC
West Des Moines, Iowa, United States
Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year]
Time frame: Up to 52 weeks
Absolute change from baseline in FVC at Week 24 [in milliLiter]
Time frame: At baseline and at week 24
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Advanced Pulmonary Research
Warren, Michigan, United States
Memorial Hospital Gulfport
Gulfport, Mississippi, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina, United States
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States
...and 153 more locations