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NCT05265273 · ClinicalTrials.gov registry record · Phase 2
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
A Phase 2 study of Myasthenia Gravis, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 19
- Study locations
NCT05265273: Recruiting Phase 2 study of Myasthenia Gravis, sponsored by Janssen Research & Development.
NCT05265273 is a Phase 2 study of Myasthenia Gravis that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 12 participants, below the 191-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (94% lower). The trial reports 19 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05265273, a Phase 2 study of Myasthenia Gravis, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 19
- Study locations
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.
Primary Outcome
Change from baseline in total serum IgG levels were reported.
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 |
What NCT05265273 shows while recruiting
NCT05265273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 191-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (94% lower).
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.
NCT05265273 lists 19 locations in 8 states (Other, California, Pennsylvania).
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.
What interventions are being tested in trial NCT05265273?
The interventions under investigation include: Nipocalimab (DRUG).
Who is sponsoring clinical trial NCT05265273?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05265273's enrollment target sits among peer trials
12 33rd of 32 the lowest of 32 other Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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