Baseline characteristics of patients enrolled in the FIBRONEER-ILD trial of nerandomilast (BI 1015550)

Background Current antifibrotic (AF) treatment for progressive pulmonary fibrosis (PPF) slows, but does not prevent, pulmonary function decline. Nerandomilast (BI 1015550), an oral preferential inhibitor of PDE4B, is being evaluated in a 52-week, randomised Phase III trial in PPF.

Aim To report the baseline demographics of patients in the FIBRONEER-ILD trial.

Methods Patients with pulmonary fibrosis other than idiopathic pulmonary fibrosis that met criteria for progression were randomised to nerandomilast 9 mg, 18 mg, or placebo twice daily. Randomisation is stratified by HRCT pattern (usual interstitial pneumonia-like vs other fibrotic patterns) and presence of background AF treatment. Baseline characteristics were collected prior to randomisation. The primary endpoint is absolute change from baseline in FVC (mL) at Week 52.

Results Database as of 10 Jan 2024: 1782 patients screened and 1177 randomised. For the 1166 treated patients, the median age is 68 years, 56% are male and 43% are receiving AF therapy. Median FVC and DLco at baseline were 69% predicted and 47% predicted, respectively. Further characteristics by AF use are shown in the Figure. This analysis is based on interim data. Updated data will be presented.

Fig. 1  

Conclusions The trial will provide insights into the efficacy and safety of nerandomilast in patients with PPF. These interim data suggest the population may be similar to that of the INBUILD trial.

Interim baseline patient and disease characteristics by

background AF use

(FIBRONEER-ILD trial)

Values are median (interquartile range) for continuous variables unless stated otherwise, based on interim data as of 10 January 2024.

*Two patients in the background AF group and two in the no background AF group identified in more than one race category.

AF, antifibrotic; DLco, diffusing capacity of the lung for carbon monoxide; FVC, forced vital capacity; HRCT, high-resolution computed tomography; HP, hypersensitivity pneumonitis; IIP, idiopathic interstitial pneumonia; ILD, interstitial lung disease; iNSIP, idiopathic non-specific interstitial pneumonia; MCTD-ILD, mixed connective tissue disease-associated ILD; RA-ILD, rheumatoid arthritis-associated ILD; SSc-ILD, systemic sclerosis-associated ILD; UIP, usual interstitial pneumonia.

Poster previously presented at the ERS, 2024

Publikationsverlauf

Artikel online veröffentlicht:
18. März 2025