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Clinical Trials in the UK / NCT05374590
Enrolling by invitation Phase 2/3

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

NCT05374590 · tracked via the Priya Life Science UK tracker
Sponsor
argenx
Phase
Phase 2/3
Started
2022-08-18
Last updated
2026-04-23

Condition(s) studied

Generalized Myasthenia GravisgMG

Investigational drug(s) / intervention(s)

Efgartigimod IV or Efgartigimod PH20 SC

Efgartigimod IV or Efgartigimod PH20 SC: Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * The participant completed ARGX-113-2006, defined as: 1. 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. 2. 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital Chicago Illinois
Atrium Health Neurology Specialty Care Charlotte North Carolina
University of Virginia (UVA) Health - Developmental Pediatrics Clinic Charlottesville Virginia
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05374590 on ClinicalTrials.gov ↗ ← All trials in the UK