MG0007
Research type
Research Study
Full title
An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
IRAS ID
289214
Contact name
Katherine Murtagh
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2020-003230-20
Duration of Study in the UK
2 years, 1 months, 12 days
Research summary
Myasthenia gravis (MG) is a serious, sometimes life threatening, debilitating autoimmune disorder associated with numerous symptoms including muscular weakness and fatigue. In autoimmune disorders a patient’s immune system attacks their own body. In the case of MG, the immune system targets and destroys body proteins responsible for communication between nerves and muscles. This then results in muscle weakness.
Several commonly prescribed treatments act, at least in part, by reducing the quantity of circulating immune system proteins. While the standard of care for MG involves the use of a variety of therapeutic agents there remains a need for a safe and effective treatment which is convenient and does not have significant side effects.
Rozanolixizumab (the “study drug”) helps break down circulating immune system proteins, including those which attack the body in MG, lowering their levels in the blood. The participants invited to participate in this study (MG0007) have been treated with this study drug in prior research studies (MG0003, MGC003, MG0004). The MG0007 study allows for continued treatment with the study drug prior to it’s authorisation by regulatory authorities for the treatment of MG.
The purpose of this open-label extension study is to understand:
1. How safe the study drug is and how well participants are able to tolerate it when given in 6-week treatment cycles;
2. How well treatment with the study drug in 6-week cycles may help reduce the symptoms of myasthenia gravis; and,
3. How the study drug acts in participants’ bodies and how their bodies reacts to it.This study will involve about 230 study participants across approximately 120 centres throughout North America, Europe, and Asia (including Japan and China). The Sponsor of this study is UCB Biopharma SRL.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0258
Date of REC Opinion
30 Nov 2020
REC opinion
Further Information Favourable Opinion