Project
BI1199.214 Senscis
Completed · 2016 until 2017
Forrer Silvia, Müller Rüdiger, Bartz-Batliner Mira, Hutz Carina Liane, Schmidig Kathrin
Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2016
End Date
2017
Financing
Industry
Study Design
This is a multi-centre, multi-national, prospective, randomised, placebo-controlled, double blind clinical trial to investigate the efficacy and safety of nintedanib at a dose of 150 mg bid, in patients with SSc-ILD. The main efficacy analysis will be assessed at week 52. Patients will stay on treatment up to a maximum of 100 weeks in order to collect follow-up safety and efficacy Information. The trial will end for all ongoing patients at the timepoint when the last patient of the trial has completed his/her primary endpoint visit after 52 weeks and follow-up visit 28 days later (last patient out timepoint).
Keywords
Nintedanib, Systemische Sklerose, interstitielle Lungenkrankheit
Brief description/objective
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).
A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis.