A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Recruiting now · Phase 2/Phase 3
Conditions studied: Myasthenia Gravis
In brief
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.
Key facts
- Study ID
- NCT05265273
- Run by
- Janssen Research & Development, LLC
- People needed
- 12
- Starts
- 2022-07-20
- Expected to finish
- 2029-07-02
- Last updated by the study team
- 2026-07-31
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (enrolling)
- Saitama Prefecture Children's Medical Center — Saitama Shi, Japan (enrolling)
- Tokyo Women's Medical University Hospital — Shinjuku-ku, Japan (enrolling)
- Leiden University Medical Center — Leiden, Netherlands (enrolling)
- Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
- Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States (enrolling)
- UCSF Benioff Children's Hospital — San Francisco, California, United States (enrolling)
- Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
- University of South Florida Morsani Center for Advanced Healthcare — Tampa, Florida, United States (enrolling)
- C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
- Penn State Milton S Hershey Medical Ctr — Hershey, Pennsylvania, United States (enrolling)
- Childrens Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Nagano Children's Hospital — Azumino-shi, Japan (enrolling)
- University of Miyazaki Hospital — Miyazaki, Japan (enrolling)
- Hyogo College of Medicine Hospital — Nishinomiya-Shi, Japan (enrolling)
- Childrens Hospital Los Angeles — Los Angeles, California, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- University of Kansas Medical Center — Lawrence, Kansas, United States
- Chiba University Hospital — Chiba, Japan
Full record on ClinicalTrials.gov
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