Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05265273
PHASE2/PHASE3

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

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