1199.214 Nintedanib vs placebo in scleroderma related lung fibrosis
A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD).
Duration of Study in the UK
2 years, 5 months, 27 days
This is a randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of nintedanib in patients with SSc-ILD (systemic sclerosis associated interstitial lung disease). All eligible patients will be randomly allocated to receive nintedanib or placebo for a maximum of 100 weeks. The study will be performed by investigators specialized in the treatment of SSc-ILD. The study is sponsored by Boehringer Ingelheim, a pharmaceutical company.
London - Hampstead Research Ethics Committee
Date of REC Opinion
10 Nov 2015
Further Information Favourable Opinion