Date: 2015-12-08
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 is a small molecule tyrosine kinase inhibitor developed by Boehringer Ingelheim. This compound targets several growth factor receptors, it inhibits platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR).
Disease: systemic sclerosis
Therapeutic area: Autoimmune diseases - Rare diseases
Country: Australia, Belgium, Canada, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, The Netherlands, Poland, Portugal, Spain, Switzerland, UK, USA
Trial
details: SENSCIS™ is a randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks up to a maximum of 100 weeks in people with systemic sclerosis associated interstitial lung disease (SSc-ILD). The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression. Key secondary endpoints include the absolute change from baseline in the modified Rodnan Skin Score (mRSS), which is an evaluation of people’s skin thickness, and the absolute change from baseline in the Saint George’s Respiratory Questionnaire (SGRQ) total score, which measures the health-related quality of life of people with lung diseases to assess the impact of treatment. (NCT02597933)
Latest
news: * On December 8, 2015, Boehringer Ingelheim announced that the first person has been enrolled in the SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS) study. The global Phase III trial, which is now open for recruitment, is investigating the efficacy and safety of nintedanib in people with systemic sclerosis (SSc) who also developed interstitial lung disease (SSc-ILD). In total, 520 people are expected to be enrolled in clinical trial centres worldwide.
