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
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2017-003158-18
ISRCTN Number
ISRCTN12345789
Clinicaltrials.gov Identifier
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