Clinical Trials

Date: 2016-06-30

Type of information: Recruitment of the first patient

phase: 3

Announcement: recruitment of the first patient

Company: Boehringer Ingelheim (Germany)

Product: Ofev® (nintedanib)

Action mechanism:

kinase inhibitor/tyrosine kinase inhibitor. Nintedanib targets three growth factors: the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR). These receptors have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis. By blocking these signaling pathways that are involved in fibrotic processes, it is hypothesized that there may be potential to reduce disease progression, and thereby slow the decline of lung function.

Disease: idiopathic pulmonary fibrosis (IPF)

Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases

Country:

Trial details:

Latest news:

• On June 30, 2016, Boehringer Ingelheim announced that the first patient has been enrolled in a new study, INMARK™, investigating the effect of Ofev® (nintedanib) on changes in specific blood biomarkers. These changes in biomarkers indicate the excessive scarring (fibrosis) in the lungs of patients with idiopathic pulmonary fibrosis (IPF). INMARK™ will measure changes in various extracellular matrix (ECM*) turnover biomarkers already shown to predict disease progression in IPF patients. ECM turnover is part of healthy tissue maintenance. However uncontrolled or excessive turnover is a key driver for the structural changes seen in IPF lungs, leading to progressive scarring and loss of lung function.
INMARK™ will investigate the effect of OFEV® on the rate of change of ECM turnover biomarkers compared to placebo in patients with IPF.Two thirds of patients will be treated with placebo for the first 12 weeks of the trial; one third of the patients will receive treatment with nintedanib (150 mg twice daily). Following the 12 week placebo controlled period, all patients in the trial will continue further treatment with nintedanib for 40 weeks.This will allow active treatment for patients previously on placebo. The study aims to include 350 patients across Australia, Asia, Europe and North America.