1199.214 Nintedanib vs placebo in scleroderma related lung fibrosis

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  185104

• Contact name

  Christopher Denton

• Contact email

  c.denton@ucl.ac.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2015-000392-28

• Duration of Study in the UK

  2 years, 5 months, 27 days

• Research summary

  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.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  15/LO/1681

• Date of REC Opinion

  10 Nov 2015

• REC opinion

  Further Information Favourable Opinion