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A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
NCT05265273 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Nipocalimab
Study Locations (19)
Other
- 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
California
- Childrens Hospital Los Angeles — Los Angeles
- Lucile Packard Children's Hospital Stanford — Palo Alto
- UCSF Benioff Children's Hospital — San Francisco
Pennsylvania
- Penn State Milton S Hershey Medical Ctr — Hershey
- Childrens Hospital Of Philadelphia — Philadelphia
- University of Pittsburgh Medical Center — Pittsburgh
Arizona
- Phoenix Children's Hospital — Phoenix
Colorado
- Children's Hospital Colorado — Aurora
Florida
- University of South Florida Morsani Center for Advanced Healthcare — Tampa
Kansas
- University of Kansas Medical Center — Lawrence
Michigan
- C.S. Mott Children's Hospital — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2029-07-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05265273
The ClinicalTrials.gov registry entry for NCT05265273 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 Janssen Research & Development, which has 442 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 Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention — of which Nipocalimab 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: NCT05265273 reports 19 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Pennsylvania. 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 NCT05265273 about?
NCT05265273 is a clinical study titled "A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis". 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...
What is the current status of trial NCT05265273?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2022-07-20. Estimated completion is 2029-07-02.
What conditions does trial NCT05265273 study?
This clinical trial studies the following conditions: 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 NCT05265273?
The interventions under investigation include: Nipocalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05265273?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05265273 being conducted?
This trial has 19 study locations across Arizona, California, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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