MOM-M281-005, M281 Injection
Research type
Research Study
Full title
An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis
IRAS ID
252987
Contact name
Saiju Jacob
Contact email
Sponsor organisation
Momenta Pharmaceuticals, Inc.
Eudract number
2018-003618-41
Duration of Study in the UK
1 years, 7 months, 27 days
Research summary
Myasthenia gravis a rare disease that affects the muscles;causes tiredness and weakness in the eye muscles,arms,legs,and neck,and may cause difficulty with breathing.Myasthenia gravis is caused mainly by antibodies that block or destroy the normal communication between nerves and muscle.M281 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 has been tested previously in animals and also in healthy human subjects for safety evaluation.The results of this previous study showed that M281 was well tolerated at single doses up to 60mg/kg(the highest single dose)and at multiple doses up to 30mg/kg(the highest repeat dose).The purpose 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 subjects with MG will be enrolled in this study.This study is an open-label extension to the blinded study MOM-M281-004,which the patient should have completed to be able to participate in this study.If the participant has not completed the study MOM-M281-004 because rescue medication was administered,the patient still may participate in the open-label extension study,if the study doctor decided this is appropriate for the patient.In this study,all patients will be receiving treatment with M281,both patient and the study doctor will be aware of the treatment administered.Starting dose will be30 mg/kg every 4 weeks.Dose and frequency may be changed 8 weeks after baseline (not higher than 60mg/kg and not more often than every 2 weeks).Depending on the chosen frequency total of 17 to 28 visits to the study site over the next 15 months will happen;visits will take from 3 to 5 hours.This will include up to 4 weeks of the screening period,52 weeks of study treatment,an 8-week follow-up period.M281 has not yet been approved by any regulatory agency for any use.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0131
Date of REC Opinion
5 Jun 2019
REC opinion
Further Information Favourable Opinion