NCT04980495

An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Generalized Myasthenia Gravis
• MG - Myasthenia Gravis
• gMG

Interventions

Type	Name	Description
BIOLOGICAL	Efgartigimod IV	Intravenous infusions of efgartigimod

Timeline

• Start date: 2021-12-16
• Primary completion: 2023-08-24
• Completion: 2025-10-06
• First posted: 2021-07-28
• Last updated: 2025-11-05

Locations

39 sites across 11 countries: United States, Austria, Belgium, Canada, France, Georgia, Germany, Italy, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study