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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
StatusRecruiting
PhasePhase 2/3
Sponsorargenx
Started2024-06-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 30, 2026 → Sep 2027
See other at-risk trials from Argenx

Amendment history

2026-09-10
Study Status, Contacts/Locations v12
Primary completion pushed: 2026-09-30 → 2027-09
Completion pushed: 2026-09-30 → 2027-09
Study sites20→21
2026-06-02
Study Status, Contacts/Locations v11
Study sites21→20
2026-06-02
Study Status, Contacts/Locations v10
Study sites20→21
2026-04-22
Study Status, Contacts/Locations v9
Study sitescontacts updated at 11 of 20 sites
2025-12-01
Study Status, Oversight, Contacts/Locations v8
Study sites17→20
Show 7 earlier versions
2025-08-14
Study Status, Contacts/Locations v7
Study sites16→17
2025-07-16
Study Identification, Study Status, Contacts/Locations v6
Study sites9→16
Study titlerevised
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age withWith Generalized Myasthenia Gravis
2025-02-28
Study Status, Contacts/Locations v5
Study sites8→9
2025-01-23
Study Status, Contacts/Locations v4
Study sites5→8
2024-12-09
Study Status, Contacts/Locations v3
Study sites3→5
2024-10-08
Study Identification, Study Status, Oversight, Contacts/Locations v2
Study sites1→3
Study titlerevised
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age Withwith Generalized Myasthenia Gravis
2024-07-03
Not Yet Recruiting→Recruiting Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
PhasePhase 3→Phase 2/3
Start dateestimated 2024-05-31→confirmed 2024-06-28
Study sites0→1
Secondary endpoints26 entries, reordered
2024-04-26
Original filing
Argenx
56 trials monitored
See 2 trials at risk
Myasthenia Gravis
187 trials monitored
See 7 trials at risk
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.
Trial Details
NCT Number NCT06392386
Lead Sponsor argenx
Conditions Generalized Myasthenia Gravis
Enrollment 12 participants
Start Date 2024-06-28
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-28