This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. People taking standard medicines for IPF, including antifibrotic medicines, can continue taking them throughout the study. The purpose of the study is to find out whether a medicine called BI 1015550 can slow down the worsening of lung function. Participants are in the study for about 4 months. During this time, they visit the study site about 7 times. At the beginning, they visit the study site every 2 weeks. After 1 month of treatment, they visit the study site every 4 weeks. The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The participants take BI 1015550 or placebo tablets twice a day. The participants have lung function tests at study visits. The results of the lung function tests are compared between the BI 1015550 group and the placebo group. The doctors also regularly check the general health of the participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.
placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.
St. Francis Medical Institute
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
The Lung Research Center, LLC
Chesterfield, Missouri, United States
The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks
The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.
Time frame: Baseline (day 1) and week 12.
The Number of Patients With Treatment Emergent Adverse Event
The number of patients with any adverse event during the on-treatment period.
Time frame: From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
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Creighton University
Omaha, Nebraska, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Diagnostics Research Group
San Antonio, Texas, United States
...and 65 more locations