Spots Global Cancer Trial Database for A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
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
Study ID: NCT05265273
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
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
Childrens Hospital Of Philadelphia, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Nagano Children's Hospital, Azumino-shi, Nagano, , 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
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
