Baseline characteristics of patients enrolled in FIBRONEER(TM)-IPF, a Phase III randomised placebo-controlled trial of the preferential PDE4B inhibitor BI 1015550 in patients with idiopathic pulmonary fibrosis

Rationale Current antifibrotic (AF) treatments for idiopathic pulmonary fibrosis (nintedanib and pirfenidone) slow, but do not stop decline in pulmonary function. BI 1015550 is an oral preferential phosphodiesterase 4B (PDE4B) inhibitor that is under investigation for treatment of IPF. In a randomized Phase II study, BI 1015550 prevented any decline in lung function over 12 weeks in IPF patients independent of background AF use. A Phase III study, FIBRONEER-IPF (NCT05321069), is currently investigating efficacy and safety of BI 1015550 in patients with IPF, with a sister trial (FIBRONEER-ILD) underway in other progressive pulmonary fibrosis (PPF). Recruitment to FIBRONEER-IPF has completed. Here, we report the baseline demographics and disease characteristics of patients enrolled in this trial.

Methods FIBRONEER-IPF is a randomized, double-blind, placebo-controlled, multicenter study in 45 countries worldwide. Patients aged≥40 years diagnosed with IPF, forced vital capacity (FVC)≥45% predicted and diffusing capacity of the lung for carbon monoxide (DL_CO)≥25% predicted were randomised 1:1:1 to receive 9 mg or 18 mg of BI 1015550 or placebo twice daily over at least 52 weeks, stratified by background AF use. Prednisone or equivalent up to 15 mg/day is permitted. The primary endpoint is absolute change from baseline in FVC at Week 52.

Fig. 1  

Results A total of 1720 patients were screened, 1176 were randomized and 1160 started treatment. Median age:71 years (42–90 years),83% were male. Most patients were White or Asian, with a higher proportion of White patients in the AF group. Median FVC at baseline was 77% and DL_CO was 48% predicted. A total of 191 patients (17%) were on oxygen therapy. A total of 815 patients (70%) were receiving background AF at baseline (480 [41%] nintedanib, 335 [29%] pirfenidone), with 345 (30%) receiving no background AF. Patients receiving background AF had a longer median time from diagnosis to study entry and were more likely to receive oxygen. Baseline characteristics by background AF use are shown in the Table.

Conclusions BI 1015550 is the first preferential PDE4B inhibitor in Phase III trials in IPF and PPF. Characteristics of patients enrolled in the FIBRONEER-IPF trial are representative of the IPF population and consistent with other Phase III trials.

Publikationsverlauf

Artikel online veröffentlicht:
18. März 2025