A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis (NCT06392386)
An Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod PH20 SC in Participants From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Carolinas HealthCare System Neurosciences Institute - Neurology — Charlotte, North Carolina
Age range: 2 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Carolinas HealthCare System Neurosciences Institute - Neurology — Charlotte, North Carolina
- Neurology Rare Disease Center — Denton, Texas
- University of Virginia — Charlottesville, Virginia
- 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,
📞 Contact the Study Coordinator
Phone: (857) 350-4834
Email: clinicaltrials@argenx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Generalized Myasthenia Gravis
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- A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis — Scottsdale, Arizona
- Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis — Orange, California
- Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis — Los Angeles, California
- Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis — Phoenix, Arizona
- A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. — Scottsdale, Arizona
Explore by condition: All Generalized Myasthenia Gravis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.