CWoW - Phase 2 study in patients with IMNM
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Immune-Mediated Necrotizing Myopathy
IRAS ID
267012
Contact name
Hector Chinoy
Contact email
Sponsor organisation
Ra Pharmaceuticals, Inc.
Eudract number
2019-001497-29
Duration of Study in the UK
2 years, 9 months, 8 days
Research summary
Research Summary
The study sponsor, Ra Pharmaceuticals Inc., is developing an investigational medication, zilucoplan, for treatment of patients with Immune-Mediated Necrotising Myopathy (IMNM). IMNM is an autoimmune disease; a disease that occurs when the immune system attacks the body’s own tissues. In IMNM, the immune system attack causes muscle weakness in muscles closest to the centre of the body, such as the forearms, thighs, hips, shoulders, neck, and back.The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with IMNM. Participants will be randomised in a 1:1: ratio to receive daily subcutaneous (under the skin) doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks followed by an open-label long-term extension.
This study will involve approximately 24 participants (male and female aged 18-75 years of age).
Summary of Results
UCB will be providing plain language summaries of all UCB-sponsored clinical trials conducted in the UK that end in 2022 and beyond. Since this clinical trial ended prior to that date, a plain language summary is not planned at this time.REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0445
Date of REC Opinion
20 Aug 2019
REC opinion
Further Information Favourable Opinion