Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis
argenx
Summary
The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: * The maximum trial duration for each individual participant will be approximately 28 weeks * The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)
Eligibility
- Age range
- 2–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ability of the participant and/or his/her legally authorized representative to understand the requirements of the trial and provide written informed consent/assent, if applicable (including consent/assent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including attending the required trial visits). 2. Male or female participants between 2 to less than 18 years of age at the time of providing informed consent/assent. Age groups are enrolled in a staggered fashion respectively: 6 pa…
Interventions
- BiologicalEfgartigimod IV
Intravenous infusion of Efgartigimod
Locations (25)
- Ann and Robert H Lurie Children's Hospital of Chicago - Main HospitalChicago, Illinois
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- University of Virginia (UVA) Health - Developmental Pediatrics ClinicCharlottesville, Virginia
- Medizinische Universitat WienVienna
- Universitair Ziekenhuis AntwerpenAntwerp
- Alberta Childrens HospitalCalgary