A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Public ClinicalTrials.gov record NCT05265273. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05265273
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 19, 2022
- Primary completion
- Jun 29, 2027
- Completion
- Jul 1, 2029
- Last update posted
- Jul 30, 2026
2022 – 2029
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | Recruiting |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | Completed |
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | 94304 | Recruiting |
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | Recruiting |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Recruiting |
| University of South Florida Morsani Center for Advanced Healthcare | Tampa | Florida | 33613 | Recruiting |
| University of Kansas Medical Center | Lawrence | Kansas | 66045 | Completed |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | Recruiting |
| Penn State Milton S Hershey Medical Ctr | Hershey | Pennsylvania | 17033 | Recruiting |
| Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19106 | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | Terminated |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05265273, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05265273 live on ClinicalTrials.gov.