ADAPT NXT
Research type
Research Study
Full title
A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG)
IRAS ID
1004454
Contact name
Antonio Guglietta
Contact email
Sponsor organisation
argenx BV
Eudract number
2021-002504-12
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to look at the effectiveness and safety of different dosing schedules of the study drug, efgartigimod, in AChR-Ab seropositive adults with generalised myasthenia gravis (gMG). The participants of this study will be people of all genders over the age of 18.
The study will have 72 participants globally and will involve two treatment parts. Part A will last 21 weeks and Part B will last up to 105 weeks, there will also be a 2 week screening period before the start of Part A. This is an open label study, so the participant and study doctor will know what treatment the participant will be receiving.
Participants will be assigned to one of four groups which will determine how often they are given a dose of the study drug and will stay in the group throughout the study. Participants will have a site visit or virtual site visit every week during Part A and every 5 weeks during Part B.
REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0066
Date of REC Opinion
31 Mar 2022
REC opinion
Further Information Unfavourable Opinion