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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