Tezepelumab (Anti-TSLP-mab) in progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia - A prospective two-armed, phase II clinical multicentre randomized, placebo-controlled (2:1), blinded with open-label extension trial (TEFIBEOS)

Progressive pulmonary fibrosis interstitial lung disease with evidence of eosinophilia

Primary endpoint: Change in blood cell count (absolute numbers) after 24 weeks Primary outcome measure: Change in number of eosinophils in differential blood cell count (absolute numbers) between baseline and 24 weeks of treatment compared to placebo.

change from baseline in forced vital capacity (FVC), Change from baseline in King’s Brief Interstitial Lung Disease Questionnaire (K-BILD) or Quality of life in patients with idiopathic pulmonary fibrosis (QPF) Questionnaire at 20 weeks, Time to decrease of FVC > 5% from baseline, Time to decrease of DLCO > 10% from baseline, Time to first acute exacerbation of underlying interstitial lung disease, Time to first all-cause hospitalization, Time to all-cause mortality, Time to composite endpoint of disease progression (defined as decline of FVC ≥ 5% or DLCOcSB ≥ 10% from baseline or death from any cause), Change from baseline in total lung capacity (TLC), Change from baseline in DLCOcSB, Change from baseline in DLCOc/VA, Change from baseline in capillary pO2, Change form baseline in 6-minute walking test distance, Change from baseline in Quality of life in patients with idiopathic pulmonary fibrosis (QPF) Questionnaire score. Key outcome measure: difference placebo vs week 24., Need to increase corticosteroid dose, Need to increase dose of disease-modifying antirheumatic drugs, Need to initiate new disease-modifying antiheumatic drugs

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