4980495
Last Update Posted: 2025-11-05
Recruiting has ended
All Genders accepted | 18 Years + |
69 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).
Study details include:
The study duration will be up to 138 weeks (including screening and a safety follow-up of up to 9 weeks)
* Part A (regimen comparison period) - 21 weeks
* Part B (extension period) - up to 105 weeks
The visit frequency, including virtual visits, will be weekly through Week 21 and every 5 weeks for the remainder of the study.
The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).
Participants will receive efgartigimod throughout the study. The participants will be randomized to the continuous regimen arm or to the cyclic regimen arm. The study consists of a part A (regimen comparison period) where participants will continue the treatment based on the treatment regimen arm they were assigned at randomization. Following part A, participants will enter part B (extension period) where all participants will receive efgartigimod in the continuous regimen. The study duration for participants is up to 138 weeks.
Eligibility
Relevant conditions:
Generalized Myasthenia Gravis
MG - Myasthenia Gravis
gMG
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov