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A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Sponsor: Janssen Research & Development, LLC
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.
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
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2022-07-20
Completion Date
2029-07-02
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Nipocalimab
Nipocalimab will be administered as an IV infusion.
Locations (19)
Phoenix Children's Hospital
Phoenix, Arizona, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of South Florida Morsani Center for Advanced Healthcare
Tampa, Florida, United States
University of Kansas Medical Center
Lawrence, Kansas, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Nagano Children's Hospital
Azumino-shi, Japan
Chiba University Hospital
Chiba, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Hyogo College of Medicine Hospital
Nishinomiya-Shi, Japan
Saitama Prefecture Children's Medical Center
Saitama Shi, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Japan
Leiden University Medical Center
Leiden, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland