NCT05374590
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
Enrolling by Invitation
PHASE2Ages 2–18InterventionalTreatmentargenx
~12 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Efgartigimod IV or Efgartigimod PH20 SC
At a glance
Recruiting sites
0 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of AEs, SAEs and AESIs
Measured over Up to 4 years
Conditions
Where it's being run
16 sites across 12 statesPoland3
Belgium2
United Kingdom2
Illinois1
North Carolina1
Virginia1
Canada1
France1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
The participant completed ARGX-113-2006, defined as:
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.
Exclusion
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.
What this trial measures
- Incidence of AEs, SAEs and AESIsUp to 4 years
AE : adverse event; SAE : serious adverse event; AESI : adverse event of special interest