1462-0004: A randomised, double-blind, placebo-controlled, dose-finding study evaluating efficacy, safety, and tolerability of different oral doses of BI 1819479 over at least 24 weeks in patients with idiopathic pulmonary fibrosis (IPF) (1462-0004)

Research summary

A multi-centre, multi-national, prospective, randomized, placebo controlled, double blind clinical trial to investigate the efficacy and safety of BI 1819479 at three different doses (0.3 mg qw, 0.1 mg qd, 0.6 mg qd) in patients with IPF administered for at least 24 weeks and up to 52 weeks. The primary objectives are to demonstrate a non-flat dose response curve based on the annual rate of decline in FVC up to 52 weeks of treatments, using three different oral doses of BI 1819479 (0.3 mg qw, 0.1 mg qd, 0.6 mg qd), and to evaluate the quantitative treatment effect size and the dose-response relationship. The secondary objective is to evaluate the efficacy by comparing the difference in FVC decline (absolute change from baseline in FVC at Week 24) for three different doses of BI 1819479 and placebo. Assessments of secondary and further efficacy and safety parameters will additionally support the selection of a dose (range) for further development.

Principal Investigator

Dr Rachel Hoyles

Contact us

Email: samantha.chilcott@ndm.ox.ac.uk

IRAS number

1009970