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203PF203 A Study to Evaluate the Efficacy and Safety of BG00011

  • Research type

    Research Study

  • Full title

    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

  • IRAS ID

    248312

  • Contact name

    Toby Maher

  • Contact email

    t.maher@rbht.nhs.uk

  • Sponsor organisation

    Biogen Idec Research Limited

  • Eudract number

    2017-003158-18

  • ISRCTN Number

    ISRCTN12345789

  • Clinicaltrials.gov Identifier

    NCT12345678

  • Clinicaltrials.gov Identifier

    NA, NA

  • Duration of Study in the UK

    3 years, 2 months, 29 days

  • Research summary

    The purpose of this study is to determine the safety and effectiveness of the study drug (BG00011) compared to placebo in participants with mild to moderate Idiopathic pulmonary fibrosis (IPF) who may or may not be receiving background therapy. The study drug will be given by an injection under the skin, also called subcutaneously (SC), once a week for 52 weeks at a dose of 56mg. Participants must be aged 40 years or older to participate. The study will be conducted at approximately 100 sites in up to 20 countries in North America, Europe, and Rest of World. Approximately 290 participants are planned to be randomised.

  • REC name

    London - Westminster Research Ethics Committee

  • REC reference

    18/LO/1258

  • Date of REC Opinion

    18 Sep 2018

  • REC opinion

    Further Information Favourable Opinion