MycarinGstudy
Research type
Research Study
Full title
A randomized, open-label extension study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis.
IRAS ID
266376
Contact name
Katherine Murtagh
Contact email
Sponsor organisation
UCB BIOPHARMA SPRL
Eudract number
2019-000969-21
Clinicaltrials.gov Identifier
132407, IND number
Duration of Study in the UK
1 years, 1 months, 18 days
Research summary
Myasthenia gravis (MG) is a serious debilitating condition which causes muscle weakness, tiredness. In MG some types of cells, Immunoglobulin G (IgG) or antibodies (body proteins) that normally fight infections, go wrong, and affect the communication between nerves and muscles which results in the muscle weakness and tiredness.\n\nSeveral commonly available treatment currently in the market acts by reducing the concentration of abnormal IgG autoantibodies in the blood. Rozanolixizumab is a molecule which works by increasing the break down of IgG. This reduces the total level of IgG including the disease-causing antibodies. By reducing the level of antibodies, it is postulated that the disease will get better controlled.\n\nThe MG0004 study is an extension of the lead-in study, MG0003. In this study, we want to see long-term safety, tolerability and effectiveness of rozanolixizumab. Study participants in MG0003 who require rescue medication (other than IVIg or PEX) during the observation period will be invited to be rerandomised in MG0004: this will offer all study participants, even those previously treated with placebo, a chance to be treated with rozanolixizumab. MG0004 offers study participants the chance to benefit from long-term treatment of rozanolixizumab.\n\nParticipants will be randomly assigned to 1 of 2 treatment arms, either 7mg/kg or 10 mg/kg rozanolixizumab dose. Both the participant and the study doctor will know which dose of rozanolixizumab participant is receiving. \n\nThe study will last for up to 60 weeks. The treatment period of 52 weeks and an observation period of 8 weeks. \n\nOnce all study visits are completed in the MG0004 study, participants will have the possibility to continue receiving rozanolixizumab through a managed access program as per applicable local regulations.\n\nSponsor is UCB Biopharma SPRL. \n\n240 participants will be enrolled at up to 100 sites from North America and Europe. \n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0579
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion