Study design of BI 1015550 for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis: a plain language summary

Abstract

Two ongoing clinical studies are part of a programme called FIBRONEER. The FIBRONEER studies are testing the drug BI 1015550 as a treatment for people with idiopathic pulmonary fibrosis (IPF) and people with progressive pulmonary fibrosis (PPF). IPF is a severe lung disease where scar tissue builds up in the lungs. The ‘idiopathic’ part means that doctors do not know the cause of the lung scarring. PPF is a general term to describe the worsening of lung scarring in any disease where scar tissue forms in the lungs, both from known causes such as other underlying diseases and for unknown reasons. While IPF can be considered to be a typical form of worsening lung scarring, in clinical studies, IPF and PPF are usually considered separately. In both IPF and PPF, scar tissue builds up in the lungs, making them smaller and no longer able to take in oxygen well. This leads to difficulty in breathing and getting oxygen to the tissues, making it difficult to perform daily activities and reducing the patient's quality of life. The symptoms and outcomes of PPF are often similar to IPF. BI 1015550 is a new study drug being developed to reduce scarring in the lungs in IPF and PPF. In the FIBRONEER studies, some participants are taking BI 1015550 and others are taking placebo. The placebo looks identical to BI 1015550 but does not contain any medicine. Researchers will compare the study drug to placebo to find out how well the study drug works. Participants may also take another approved medicine to treat their lung scarring. The FIBRONEER studies are investigating the effects of BI 1015550 alone and in combination with any existing medicines the participants are taking. The goal is to see whether BI 1015550 can slow down or stop a decline in lung function in people with IPF and PPF, and how well it is tolerated.