drugset / Trial / NCT05265273

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

NCT05265273

Phase 2/3 Recruiting 12 enrolled Janssen Research & Development, LLC
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-20
Primary completion
2026-06-26
Completion
2029-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Nipocalimab Monoclonal antibody Intravenous

Indications