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

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507379-23-00

Acronym

ARGX-113-2008

Enrollment

Registered

2024-01-31

Start date

2022-08-18

Completion date

Unknown

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Brief summary

Incidence and severity of adverse events (AEs), Incidence and severity of serious adverse events (SAEs), Incidence and severity of adverse events of special interest (AESIs), Changes in laboratory test results, vital signs, height and weight, and electrocardiogram (ECG) results

Detailed description

Incidence and prevalence of antidrug antibodies (ADAs) against efgartigimod and antibodies against recombinant human hyaluronidase PH20 (rHuPH20).

Interventions

DRUGARGX-113

DRUGVyvgart 20 mg/mL concentrate for solution for infusion

DRUGVyvgart 1 000 mg solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events (AEs), Incidence and severity of serious adverse events (SAEs), Incidence and severity of adverse events of special interest (AESIs), Changes in laboratory test results, vital signs, height and weight, and electrocardiogram (ECG) results	—

Secondary

Measure	Time frame
Incidence and prevalence of antidrug antibodies (ADAs) against efgartigimod and antibodies against recombinant human hyaluronidase PH20 (rHuPH20).	—

Countries

Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026