Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
NCT ID: NCT05374590
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2/PHASE3
12 participants
INTERVENTIONAL
2022-08-18
2029-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Efgartigimod or Efgartigimod PH20 SC
Patients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment
Efgartigimod IV or Efgartigimod PH20 SC
Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC
Interventions
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Efgartigimod IV or Efgartigimod PH20 SC
Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC
Eligibility Criteria
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Inclusion Criteria
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
* 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.
2 Years
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital
Chicago, Illinois, 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
Countries
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Other Identifiers
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2023-507379-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-113-2008
Identifier Type: -
Identifier Source: org_study_id