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

<bold>Background:</bold> 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. <bold>Aims:</bold> To report the baseline demographics of patients in the FIBRONEER-ILD trial. <bold>Methods:</bold> 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. <bold>Results:</bold> 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. <bold>Conclusions:</bold> 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. <fig><object-id>erj;64/suppl_68/PA671/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>