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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC
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
...and 6 more locations
Incidence of AEs, SAEs and AESIs
AE : adverse event; SAE : serious adverse event; AESI : adverse event of special interest
Time frame: Up to 4 years
Incidence of ADAs against efgartigimod
ADA : anti-drug antibody
Time frame: Up to 4 years
Incidence of antibodies against rHuPH20
rHuPH20: recombinant human hyaluronidase PH20
Time frame: Up to 4 years
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