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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
argenx
Study ID
NCT05374590
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Generalized Myasthenia Gravis
  • gMG

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 18, 2022
Status verified
Jan 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod or Efgartigimod PH20 SC
    Patients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment

Primary Outcome Measure

Incidence of AEs, SAEs and AESIs [ Time Frame: Up to 4 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Ann and Robert H Lurie Children's Hospital of Chicago - Main HospitalChicagoIllinois60611-
Atrium Health Neurology Specialty CareCharlotteNorth Carolina28207-
University of Virginia (UVA) Health - Developmental Pediatrics ClinicCharlottesvilleVirginia22903-

Find similar trials in Chicago, IL

By research site
Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital· Chicago, ILAtrium Health Neurology Specialty Care· Charlotte, NCUniversity of Virginia (UVA) Health - Developmental Pediatrics Clinic· Charlottesville, VA

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