NCT05265273

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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Nipocalimab	Nipocalimab will be administered as an IV infusion.

Timeline

• Start date: 2022-07-20
• Primary completion: 2026-06-26
• Completion: 2029-07-02
• First posted: 2022-03-03
• Last updated: 2026-03-13

Locations

19 sites across 4 countries: United States, Japan, Netherlands, Poland

Regulatory

• FDA-regulated drug study