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By invitation only Phase 2/3 NCT05374590

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

Phase 2/3 – combined trial
Conditions: Generalized Myasthenia Gravis gMG

Sponsor: argenx

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Efgartigimod IV or Efgartigimod PH20 SC
BIOLOGICAL
Locations 16
Belgium (2)
Universitair Ziekenhuis Antwerpen
Edegem
UZ Gent
Ghent
Canada (1)
Childrens Hospital of Eastern Ontario
Ottawa
France (1)
AP-HM- Hôpital de La Timone
Marseille
Germany (1)
Universitätsklinikum Essen
Essen
Israel (1)
Hadassah Medical Center- Ein Kerem
Jerusalem
Netherlands (1)
Leids Universitair Medisch Centrum
Leiden
Poland (3)
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk
Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice
Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM
Warsaw
Spain (1)
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
United Kingdom (2)
Great Ormand Street Hospital for Children NHS Foundation Trust - Great Ormond Street Hospital - Pediatric Neurology
London
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital Children's Hospital
Oxford
United States (3)
Atrium Health Neurology Specialty Care
Charlotte , North Carolina
University of Virginia (UVA) Health - Developmental Pediatrics Clinic
Charlottesville , Virginia
Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital
Chicago , Illinois
Technical details
Status
By invitation only
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
18.08.2022
Completion date
01.09.2029
Registry ID
NCT05374590
Source
clinicaltrials.gov
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