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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
NCT06392386 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06392386 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, North Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06392386?
The interventions under investigation include: Efgartigimod PH20 SC (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06392386?
This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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