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NCT06392386 · ClinicalTrials.gov registry record · Phase 2
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis
A Phase 2 study of Generalized Myasthenia Gravis, sponsored by argenx.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 20
- Study locations
NCT06392386 is a Phase 2 study of Generalized Myasthenia Gravis that is actively recruiting participants, run by argenx. The registered enrollment target is 12 participants, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT06392386, a Phase 2 study of Generalized Myasthenia Gravis, is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Efgartigimod PH20 SC
Study Locations (20)
Other
- UZ Gent - Ghent
- Childrens Hospital of Eastern Ontario - Ottawa
- Fakultni nemocnice Brno - Brno
- Fakultni nemocnice Ostrava - Ostrava
- AP-HM- Hôpital de La Timone - Marseille
- Universitätsklinikum Essen - Essen
- Hadassah Medical Center- Ein Kerem - Jerusalem
- Schneider Children's Medical Center of Israel - Petah Tikvah
- Tel Aviv Sourasky Medical Center Ichilov - Tel Aviv
- Istituto G Gaslini Ospedale Pediatrico IRCCS - Genova
- Leiden University Medical Center - Leiden
- Uniwersyteckie Centrum Kliniczne w Gdansku - Gdansk
- Neurologia Śląska Centrum Medyczne - Katowice
- Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM - Warsaw
- Hospital Universitari i Politecnic La Fe de Valencia - Valencia
- Hôpital Nestlé - Lausanne
- Oxford Children's Hospital - Oxford
North Carolina
- Carolinas HealthCare System Neurosciences Institute - Neurology - Charlotte
Texas
- Neurology Rare Disease Center - Denton
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-06-28 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06392386
The ClinicalTrials.gov registry entry for NCT06392386 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (91% lower). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention - of which Efgartigimod PH20 SC is the first listed.
NCT06392386 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT06392386 about?
NCT06392386 is a clinical study titled "A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis". 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...
What is the current status of trial NCT06392386?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2024-06-28. Estimated completion is 2026-09-30.
What conditions does trial NCT06392386 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT06392386?
The interventions under investigation include: Efgartigimod PH20 SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT06392386?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06392386 being conducted?
This trial has 20 study locations across North Carolina, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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