A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Start Date
7/20/2022
Completion Date
7/2/2029
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.
Eligibility Criteria
Age Range: 2 years to 17 years
Interventions
Nipocalimab
Conditions
Locations
Phoenix Children's Hospital
Phoenix, Arizona 85016
United States
Childrens Hospital Los Angeles
Los Angeles, California 90027
United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California 94304
United States
UCSF Benioff Children's Hospital
San Francisco, California 94158
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
University of South Florida Morsani Center for Advanced Healthcare
Tampa, Florida 33613
United States
University of Kansas Medical Center
Lawrence, Kansas 66045
United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan 48109
United States
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania 17033
United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania 19106
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15224
United States
Nagano Children's Hospital
Azumino-shi, 399-8288
Japan
Chiba University Hospital
Chiba, 260 8677
Japan
University of Miyazaki Hospital
Miyazaki, 889-1692
Japan
Hyogo College of Medicine Hospital
Nishinomiya-Shi, 663-8501
Japan
Saitama Prefecture Children's Medical Center
Saitama Shi, 330-8777
Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666
Japan
Leiden University Medical Center
Leiden, 2333 ZA
Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 211
Poland