ALXN1720-MG-301
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis
IRAS ID
1006358
Contact name
Maria Leite
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Eudract number
2022-000460-21
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine if the study medication (ALXN1720) is safe and effective in the treatment of generalised Myasthenia gravis (gMG). About 200 participants with gMG of more than 18 years of age will take part in this study. The study duration will be approximately 2 years and 5 months. Patients will have about 39 visits, including 24 visits at the study site and 15 remote visits.
The study has 3 periods: Screening period that will last up to 4 weeks, randomised controlled treatment period that will last 6 months and the open label extension period that will last approximately 1 year and 10 months. The following tests and procedures will be performed:
Questions about you, Physical examination, Height and weight check, Vital signs, Blood and urine collection, Urine tests, Pregnancy tests, Alcohol and drug test, Electrocardiography, Questionnaires, Vaccination and Electronic Diary.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0741
Date of REC Opinion
19 Dec 2022
REC opinion
Further Information Favourable Opinion