Design of Phase III, Randomized, Placebo-Controlled Trials of BI 1015550 in Patients with Progressive Fibrosing Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis (FIBRONEER-ILD / -IPF)

Background/Purpose There is a need for better treatments that modify the disease course and improve symptoms of idiopathic pulmonary fibrosis (IPF) and other progressive fibrosing interstitial lung diseases (PF-ILD). BI 1015550, a preferential phosphodiesterase 4B inhibitor, prevented lung function decline in a Phase II study in IPF. Based on its anti-inflammatory and antifibrotic properties it may provide an additional treatment option, alone or with nintedanib, in patients with IPF or PF-ILD. Methods We describe the design of the FIBRONEER-ILD TM and FIBRONEER-IPF™ trials, two randomized, placebo-controlled, Phase III studies evaluating the efficacy and safety of BI 1015550 in patients with PF-ILD (NCT05321082) or with IPF (NCT05321069). Patients will be randomized in a 1:1:1 ratio to either BI 1015550 18 mg twice daily (BID), 9 mg BID, or placebo in addition to standard of care, over at least 52 weeks ([ Figure 1 ]). The primary endpoint is the absolute change from baseline in FVC (mL) at Week 52. The key secondary endpoint is the time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death, over the duration of the trial. FIBRONEER-ILD TM will be stratified by HRCT pattern (UIP vs other fibrotic pattern), and by baseline use of nintedanib (yes/no); FIBRONEER-IPF™ by the presence or absence of background treatment with antifibrotics ([ Fig. 2 ]). Fig. 1 Study design schematic. Fig. 2 Main inclusion and exclusion criteria Results In Germany the trials are planned to be conducted in 70 patients each at 25 study sites, with a recruitment start in Q.4/2022 and a planned completion date in March 2025. Conclusion The FIBRONEER-ILD TM and FIBRONEER-IPF™ trials are designed to investigate the potential use of BI 1015550 as a treatment option for patients with non-IPF progressive fibrosing ILDs or IPF, respectively, with and without background antifibrotic medication. Funding The studies are sponsored by Boehringer Ingelheim International GmbH Publication History Article published online: 09 March 2023 © 2023. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany