BI 1015550
Drug18 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.
NCT Number: NCT04419506
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.
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Notify Me40 year and older
All sexes
Interventional
Phase 2
Centro de Investigaciones Metabólicas (CINME), C.a.b.a, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
and
[*stable therapy is defined as the individually and general tolerated regimen of either pirfenidone or nintedanib]
Exclusion criteria
Further exclusion criteria apply.
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.
Time frame: Baseline (day 1) and week 12.
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: From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
The number of patients with any adverse event during the on-treatment period.
Boehringer Ingelheim
Industry
A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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