Clinical Trial

A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis

Study acronym: ADAPT Jr SC
Recruiting Phase 2/3
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2024-04-26; most recent amendment 2026-06-02.
Status change: Not Yet Recruiting → Recruiting 2024-07-03
Trial Details
NCT Number NCT06392386
Lead Sponsor argenx
Conditions Generalized Myasthenia Gravis
Enrollment 12 participants
Start Date 2024-06-28
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-04