NCT06909214

A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.

Conditions

• New Onset Generalized Myasthenia Gravis (gMG)

Interventions

Type	Name	Description
BIOLOGICAL	Efgartigimod PH20 SC	Subcutaneous injection of efgartigimod PH20 SC

Timeline

• Start date: 2025-04-17
• Primary completion: 2026-08-01
• Completion: 2027-05-01
• First posted: 2025-04-03
• Last updated: 2026-03-10

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study