Study of Nipocalimab Given by IV Infusion in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis to Evaluate Safety and Treatment Effects

What this Trial Is About

Researchers are evaluating the effects of nipocalimab on children aged 2 to less than 18 years with generalized myasthenia gravis gMG, a condition causing muscle weakness. The study aims to assess the safety, tolerability, and how the body processes nipocalimab in pediatric participants who have not responded well to stable standard treatments. This open-label, multicenter trial is sponsored by Janssen Research & Development, LLC and focuses on both pharmacokinetics and pharmacodynamics over an extended period. Participants are divided into two age groups children aged 2 to less than 12 years and adolescents aged 12 to less than 18 years, with US sites only including those 8 to less than 18 years old. All will receive nipocalimab through an intravenous infusion every two weeks for 24 weeks. After this treatment period, participants may choose to join a long-term extension phase to continue monitoring. Throughout the study, participants will undergo regular evaluations including blood tests to measure total serum immunoglobulin G IgG levels and monitor for adverse events, laboratory abnormalities, vital signs, and physical examinations. Additional assessments include measuring drug concentration and immune response markers. The study also tracks changes in myasthenia gravis symptoms and quality of life over a period of up to three years, with ongoing safety and pharmacokinetic monitoring during this time.

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