A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis (NCT05265273)
An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.
Who can join: Review the eligibility criteria below.
Location: Phoenix Children's Hospital — Phoenix, Arizona
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 (19 Sites)
- Phoenix Children's Hospital — Phoenix, Arizona
- Childrens Hospital Los Angeles — Los Angeles, California
- Lucile Packard Children's Hospital Stanford — Palo Alto, California
- UCSF Benioff Children's Hospital — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- University of South Florida Morsani Center for Advanced Healthcare — Tampa, Florida
- University of Kansas Medical Center — Lawrence, Kansas
- C.S. Mott Children's Hospital — Ann Arbor, Michigan
- Penn State Milton S Hershey Medical Ctr — Hershey, Pennsylvania
- Childrens Hospital Of Philadelphia — Philadelphia, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Nagano Children's Hospital — Azumino-shi,
- Chiba University Hospital — Chiba,
- University of Miyazaki Hospital — Miyazaki,
- Hyogo College of Medicine Hospital — Nishinomiya-Shi,
- Saitama Prefecture Children's Medical Center — Saitama Shi,
- Tokyo Women's Medical University Hospital — Shinjuku-ku,
- Leiden University Medical Center — Leiden,
- Uniwersyteckie Centrum Kliniczne — Gdansk,
📞 Contact the Study Coordinator
Phone: (844) 434-4210
Email: Participate-In-This-Study1@its.jnj.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 Myasthenia Gravis
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- Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis — Phoenix, Arizona
- Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis — Boston, Massachusetts
- Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis — Saint Paul, Minnesota
- A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG) — Colorado Springs, Colorado
Explore by condition: All 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.