An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEER™-ON)

idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PPF)

any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99.

Absolute change from baseline in FVC (mL) and in % predicted FVC over time, Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial, Time to first acute IPF/PPF exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial, Time to first acute IPF/PPF exacerbation or death over the duration of the trial, Time to hospitalisation for respiratory cause or death over the duration of the trial, Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial, Time to relative decline in FVC % predicted of >10% from baseline or death over the duration of the trial

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Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden