This trial is part of the FIBRONEER international programme, which comprises two Phase III studies, FIBRONEER-IPF and FIBRONEER-ILD.
FIBRONEER-IPF is being carried out in IPF patients while FIBRONEER-ILD is for individuals with other progressive fibrosing interstitial lung diseases (ILDs).
These double-blind, randomised, placebo-controlled trials are designed to evaluate the safety, efficacy, and tolerability of BI 1015550 over a minimum of 52 weeks in IPF and progressive fibrosing ILD patients.
The absolute variation in forced vital capacity (FVC ) from baseline at week 52 is the primary endpoint of both studies.
The time to the first incidence of any of the following components of the composite endpoint: time to first exacerbation of acute IPF/ILD, first hospital admission for respiratory cause, or mortality during the studies is the key secondary endpoint.
Subject-reported outcomes will be evaluated as the additional secondary endpoints of the trials.
An oral investigational therapy, BI 1015550 is an inhibitor of phosphodiesterase 4B (PDE4B).
In February this year, the therapy was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for IPF.
Boehringer Ingelheim Pulmonary Fibrosis director Dr Donald Zoz said: “As the global market leader in pulmonary fibrosis, our ambition is to move beyond slowing down disease progression and one day provide a cure for this devastating condition.
“Enrolling the first patient in our Phase III programme is a critical step to help bring forward this next generation of treatment to those in need as quickly as possible.”
In May this year, the company reported Phase II trial data where BI 1015550 demonstrated to reduce the rate of lung function decline in IPF patients.