NCT06298552

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 2.5 years.

Conditions

• Generalized Myasthenia Gravis
• gMG
• Myasthenia Gravis, Generalized
• Myasthenia Gravis

Interventions

Type	Name	Description
BIOLOGICAL	Efgartigimod IV	Intravenous infusion of efgartigimod
OTHER	Placebo IV	Intravenous infusion of placebo

Timeline

• Start date: 2024-04-16
• Primary completion: 2025-06-30
• Completion: 2027-06-01
• First posted: 2024-03-07
• Last updated: 2025-11-05

Locations

91 sites across 22 countries: United States, Belgium, Canada, China, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study