A double-blind, randomized, placebo-controlled trial investigating the efficacy and safety of nerandomilast over at least 52 weeks in patients with fibrosing interstitial lung disease at risk for disease progression (FIBRONEER-ACT)

Interstitial lung diseases

Absolute change from baseline in FVC (mL) at Week 52

Absolute change from baseline in total disease extent (TDE [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52, Absolute change from baseline in reticulovascular score (RVS [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52, Absolute change from baseline in FVC (% predicted) at Week 52, Time to development of incident progressive pulmonary fibrosis (PPF) (as assessed and documented by investigator; for further definition, see protocol) or death over the duration of the trial, Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial, Time to relative decline from baseline in FVC (% predicted) of >10% or death over the duration of the trial, Absolute change from baseline in DLCO (% predicted) at Week 52, Time to absolute decline from baseline in DLCO (% predicted) of >10% or death over the duration of the trial

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