Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
Sponsor: argenx
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
Conditions
Interventions
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