A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
Start Date
6/28/2024
Completion Date
9/30/2026
Summary
The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to \<18 years. The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study. Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study. At the end of the follow-up period, eligible participants may roll over to an open-label extension (OLE) study. The participants will be in the study for up to 14 weeks.
Eligibility Criteria
Age Range: 2 years to 17 years
Interventions
Efgartigimod PH20 SC
Conditions
Locations
Carolinas HealthCare System Neurosciences Institute - Neurology
Charlotte, North Carolina 28207
United States
Neurology Rare Disease Center
Denton, Texas 76208
United States
University of Virginia
Charlottesville, Virginia 22903
United States
UZ Gent
Ghent, 9000
Belgium
Childrens Hospital of Eastern Ontario
Ottawa, K1H 8L1
Canada
Fakultni nemocnice Brno
Brno, 613 00
Czechia
Fakultni nemocnice Ostrava
Ostrava, 708 00
Czechia
AP-HM- Hôpital de La Timone
Marseille, 13385
France
Universitätsklinikum Essen
Essen, 45147
Germany
Hadassah Medical Center- Ein Kerem
Jerusalem, 9112001
Israel
Schneider Children's Medical Center of Israel
Petah Tikvah, 4920235
Israel
Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv, 6423906
Israel
Istituto G Gaslini Ospedale Pediatrico IRCCS
Genova, 16147
Italy
Leiden University Medical Center
Leiden, 2333 ZA
Netherlands
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk, 80-211
Poland
Neurologia Śląska Centrum Medyczne
Katowice, 40-689
Poland
Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM
Warsaw, 02-097
Poland
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Spain
Hôpital Nestlé
Lausanne, 1011
Switzerland
Oxford Children's Hospital
Oxford, OX3 9DU
United Kingdom