Clinical Trial

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Study acronym: ADAPT Jr
Recruiting Phase 2/3
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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)
Protocol Amendment History 24 amendments
This ClinicalTrials.gov record has been amended 24 times since 2021-04-02; most recent amendment 2026-02-16.
Status change: Not Yet Recruiting → Recruiting 2021-11-26
Trial Details
NCT Number NCT04833894
Lead Sponsor argenx
Conditions Generalized Myasthenia Gravis
Enrollment 12 participants
Start Date 2021-10-26
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-18