ARGX-113-1704 - ADAPT
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness
IRAS ID
250761
Contact name
Saiju Jacob
Contact email
Sponsor organisation
argenx BVBA
Eudract number
2018-002132-25
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 0 days
Research summary
Generalised Myasthenia gravis (gMG) is a chronic, autoimmune condition (where the immune system attacks the body) that causes muscle weakness and excessive muscle fatigue. The muscle weakness fluctuates with activity, and symptoms may be relieved temporarily after periods of rest. The treatment of gMG is based on a variety of medications and medical procedures used either alone or in combination. Treatments include acetylcholine inhibitors (which help electrical signals travel between the nerves and muscles, providing temporary reduction in muscle weakness), corticosteroids, immunosuppressants, new treatments such as rituximab and eculizumab, therapeutic plasma exchange (PLEX) (which removes substances such as harmful antibodies from the blood), and surgery to remove the thymus gland. These treatments can help keep the symptoms of gMG under control, but some provide only short periods of relief, requiring several doses each day, and some are associated with frequent and often serious side effects.
The purpose of this clinical study is to evaluate how well the study drug, ARGX-113, works and how safe it is compared to a placebo in participants with gMG. The study will involve about 150 participants with gMG.
Participants will be randomly assigned to either ARGX-113 or a placebo, with a 50% chance (1 in 2) of receiving either option. They will be administered ARGX-113 (dose of 10mg per kg of body weight with a maximum of 1200mg) or a placebo at 4 weekly infusions, for a period of 3 weeks, on an “as needed basis” on top of their standard of care during Treatment Periods. The time between Treatment Periods is based on how long the treatment is effective, and may vary between participants. The study will last for approximately 28 weeks, with the participants needing to visit the study centre at least 19 times over this period.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0372
Date of REC Opinion
31 Jan 2019
REC opinion
Further Information Favourable Opinion