A double blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF)

Condition studied

Pulmonary fibrosis, Interstitial lung diseases, Familial pulmonary fibrosis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Time to physiologic or radiologic worsening of ILA/ILD (defined as: relative decline in FVC % predicted of >10% from baseline; or absolute decline in DLCO % predicted >10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) >2% and total disease extent (TDE) >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring, from baseline) over the whole trial

Endpoint detail

Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104, Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104, Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104, Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial, Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial, Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring over 52 weeks and over the whole trial, Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks