Clinical Trials

Date: 2017-03-20

Type of information: Recruitment of the first patient

phase: 3

Announcement: recruitment of the first patient

Company: Boehringer Ingelheim (Germany)

Product: 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.
In animal models, the anti-fibrotic activity of nintedanib was shown to be independent of the cause of the fibrosing lung disease.
Nintedanib is marketed as Ofev®, is approved for a rare lung disease, idiopathic pulmonary fibrosis.

Disease: progressive fibrosing interstitial lung disease (PF-ILD)

Therapeutic area: Lung diseases - Respiratory diseases

Country: Argentina, Canada, Chile, Germany, Italy, Japan, Republic of Korea, Poland, Russian Federation, Spain, UK, USA

Trial details:

This double-blind, randomised, placebo-controlled study will evaluate the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks in patients with PF-ILD. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression. Other clinical evaluations include the absolute change from baseline in the King's Brief Interstitial Lung Disease Questionnaire (K-BILD), which measures the health-related quality of life of patients with ILDs to assess the impact of treatment. Other main secondary endpoints include time to first ILD exacerbation and overall survival. The study will include patients with PF-ILD with documented lung scarring on imaging (high-resolution computer tomography, HRCT), and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment.
The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. (NCT02999178)

Latest news:

• On March 20, 2017, Boehringer Ingelheim announced that the first patient has been enrolled in the PF-ILD (progressive fibrosing interstital lung disease) trial. This study investigates the efficacy and safety of nintedanib in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis (IPF). There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in IPF, it is anticipated that nintedanib will be a new treatment option for patients with PF-ILD.