Investigating the effects of nintedanib on biomarkers of extracellular matrix turnover in patients with IPF: design of the randomised placebo-controlled INMARK®trial.

BMJ Open Respiratory Research
Toby M MaherR Gisli Jenkins

Abstract

A feature of the pathogenesis of idiopathic pulmonary fibrosis (IPF) is the excess accumulation of extracellular matrix (ECM) in the lungs. Cleavage of the ECM by metalloproteinases (MMPs) generates free-circulating protein fragments known as neoepitopes. The PROFILE study suggested that changes in ECM turnover proteins may be of value as markers of disease progression in patients with IPF. Nintedanib is an approved treatment for IPF that slows disease progression by reducing decline in forced vital capacity (FVC). The INMARK® trial is evaluating the effect of nintedanib on the rates of change of biomarkers of ECM turnover in patients with IPF, the value of changes in these biomarkers as predictors of disease progression and whether nintedanib affects the associations between changes in these biomarkers and disease progression. Following a screening period, 347 patients with IPF and FVC ≥80% predicted were randomised 1:2 to receive nintedanib 150 mg two times a day or placebo for 12 weeks, followed by an open-label period in which all patients will receive nintedanib for 40 weeks. The primary endpoint is the rate of change in C reactive protein degraded by MMP-1/8 from baseline to week 12. This trial is being conducted in compl...Continue Reading

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Citations

Mar 2, 2019·Breathe·Olivier BurgyJana De Brandt
Mar 16, 2019·Respiratory Research·Martin Kolb, Martina Vašáková
Sep 6, 2019·European Respiratory Review : an Official Journal of the European Respiratory Society·Vivien SomogyiMichael Kreuter
Mar 20, 2019·The European Respiratory Journal·Paul J Wolters, Vincent Cottin
Jan 8, 2020·Respiratory Research·Claudia ValenzuelaMichael Kreuter
Mar 29, 2021·Pharmacology & Therapeutics·Gang LiuPhilip M Hansbro

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Methods Mentioned

BETA
bronchoalveolar
lavage
biopsy
X-ray

Clinical Trials Mentioned

NCT02788474

Software Mentioned

INMARK®
PROFILE

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