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

Enrolling by invitation · Phase 2/Phase 3

Conditions studied: Generalized Myasthenia Gravis, gMG

In brief

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.

Key facts

Study ID

NCT05374590

Run by

argenx

People needed

12

Starts

2022-08-18

Expected to finish

2029-09-01

Last updated by the study team

2026-04-23

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant completed ARGX-113-2006, defined as:
• The participant reached End of Trial in trial ARGX-113-2006 or End of Study in ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial.
• The participant qualifies for retreatment in trial ARGX-113-2006, but cannot complete a Treatment Period (TP) and the required Intertreatment Period (IP) visits within the ARGX-113-2006 trial's timeframe.
• Either the participant or the participant's legally authorized representative can understand the requirements of the trial and provide written informed consent/assent, and willingness and ability to comply with the trial protocol procedures.
• Contraceptive use for sexually active participants should be consistent with local regulations for those participating in clinical studies.

You may not qualify if…

• Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, or the participant intends to become pregnant during their participation in the study.
• Discontinued early from ARGX-113-2006 or ARGX-113-2207 treatment.
• Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at study entry not sufficiently resolved in the investigator's opinion or known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or put the participant at undue risk.

Where it is running

• 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

Full record on ClinicalTrials.gov

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