MOM-M281-004, M281 Injection
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis
IRAS ID
252984
Contact name
Saiju Jacob
Contact email
Sponsor organisation
Momenta Pharmaceuticals, Inc.
Eudract number
2018-002247-28
Duration of Study in the UK
1 years, 2 months, 21 days
Research summary
Myasthenia gravis (MG) is a rare disease that affects the muscles and brain; causes tiredness and weakness in the eye muscles, arms, legs, and neck, and may cause difficulty with breathing. The patient must be diagnosed with myasthenia gravis to be in this study. Myasthenia gravis is caused mainly by antibodies that block or destroy the normal communication between nerves and muscle.
M281, an investigative drug, is designed to block a receptor called FcRn, a receptor that reduces the antibodies that cause Myasthenia gravis and may potentially treat the disease. M281, an investigative drug, has been tested previously in animals and also in healthy human participants for safety evaluation. The results of this previous study showed that M281 was well tolerated at single doses up to 60 mg/kg (the highest single dose tested) and at multiple doses up to 30 mg/kg (the highest repeat dose tested). The purpose of this study is to determine whether M281 is safe and effective in the treatment of this disease, along with the standard treatment. It is expected that approximately 60 participants with MG will be enrolled in this study among 45 study centers internationally.
Participants will have a total of 9 visits to the study site over the next 5 months; each visit will take approximately 5 hours. The study doctor will discuss the requirements of participating in the study and what is needed to qualify. This will include up to 4 weeks of the screening (qualification) period, 8 weeks of study treatment, and an 8-week follow-up period.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0007
Date of REC Opinion
5 Feb 2019
REC opinion
Further Information Favourable Opinion