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ENROLLING BY INVITATION
NCT05374590
PHASE2/PHASE3

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

Sponsor: argenx

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2022-08-18

Completion Date

2029-09

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Efgartigimod IV or Efgartigimod PH20 SC

Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC

Locations (16)

Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital

Chicago, Illinois, United States

Atrium Health Neurology Specialty Care

Charlotte, North Carolina, United States

University of Virginia (UVA) Health - Developmental Pediatrics Clinic

Charlottesville, Virginia, United States

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

UZ Gent

Ghent, Belgium

Childrens Hospital of Eastern Ontario

Ottawa, Canada

AP-HM- Hôpital de La Timone

Marseille, France

Universitätsklinikum Essen

Essen, Germany

Hadassah Medical Center- Ein Kerem

Jerusalem, Israel

Leids Universitair Medisch Centrum

Leiden, Netherlands

Uniwersyteckie Centrum Kliniczne w Gdansku

Gdansk, Poland

Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, Poland

Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM

Warsaw, Poland

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Great Ormand Street Hospital for Children NHS Foundation Trust - Great Ormond Street Hospital - Pediatric Neurology

London, United Kingdom

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital Children's Hospital

Oxford, United Kingdom