NCT05374590

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

A Long-term, Single-Arm, Open-label, Multicenter Trial to Evaluate Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: argenx · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively. Participants will receive efgartigimod IV or efgartigimod PH20 SC, using the dose administered in the antecedent studies. Participants who have not reached the age of 18 can remain in the study until efgartigimod becomes commercially available in the respective country or available through another continued access program for gMG. Participants who have reached the age of 18 can remain in the study for a maximum of 2 years, until efgartigimod becomes commercially available in the respective country or available through another continued access program for gMG, whichever comes first.

Conditions

• Generalized Myasthenia Gravis
• gMG

Interventions

Type	Name	Description
BIOLOGICAL	Efgartigimod IV or Efgartigimod PH20 SC	Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC

Timeline

• Start date: 2022-08-18
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2022-05-16
• Last updated: 2026-02-02

Locations

16 sites across 10 countries: United States, Belgium, Canada, France, Germany, Israel, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study