A study of IMO-8400 in Patients with Dermatomyositis
Research type
Research Study
Full title
A Phase 2, Randomised, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with Dermatomyositis
IRAS ID
188434
Contact name
Catherine E Hogben
Contact email
Sponsor organisation
Idera Pharmaceuticals, Inc.
Eudract number
2015-003277-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 8 days
Research summary
Dermatomyositis (DM) is a rare, progressively debilitating disorder that affects the muscle (causing weakness) and skin. Additionally, it can also involve multiple bodily systems including the lungs, joints, gut and heart. It is more common in women than in men, with peak age of onset from 45 to 65 years in adults.
The purpose of this study is to see how safe and effective IMO-8400 is in adult participants with DM with active skin and muscle involvement.
Patients with DM who agree to be in this study will receive either IMO-8400 or placebo (treatment containing no drug).To make the comparison between IMO-8400 and placebo as fair as possible, this study is “double blinded.” This means that neither the participant nor the study doctor will know which kind of treatment they are receiving. Which treatment they will be given will be decided randomly, like tossing a coin.
Patients diagnosed with DM over the age of 18 could be eligible to participate in this study. There will be 36 participants in this study at approximately 20 study centres in the U.K. and the U.S.
Participants will come to the study site for a total of about 27 visits over a 32 week period.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1312
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion