OncoMatch/Clinical Trials/NCT06392386
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
Is NCT06392386 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Efgartigimod PH20 SC for generalized myasthenia gravis.
Treatment: Efgartigimod PH20 SC — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: immunosuppressant
unsatisfactory response to immunosuppressants
Must have received: corticosteroid
unsatisfactory response to corticosteroids
Must have received: acetylcholinesterase inhibitor
unsatisfactory response to acetylcholinesterase inhibitors
Cannot have received: plasma exchange
Exception: documented lack of clinical response
documented lack of clinical response to plasma exchange (PLEX)
Cannot have received: live or live-attenuated vaccine
Exception: within <4 weeks before screening
Received a live or live-attenuated vaccine within <4 weeks before screening
Cannot have received: thymectomy
Exception: within 3 months before screening or planned during study
Received a thymectomy within 3 months before screening or is planning to get a thymectomy during their participation in the study
Cannot have received: other study drug
Exception: within <12 before screening
Has received a different study drug in another clinical study within <12 before screening
Cannot have received: efgartigimod
Exception: previous participation and received at least one dose
Has previously participated in an efgartigimod clinical study and received at least one dose of study drug
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Carolinas HealthCare System Neurosciences Institute - Neurology · Charlotte, North Carolina
- Neurology Rare Disease Center · Denton, Texas
- University of Virginia · Charlottesville, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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