An Open-Label Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis to Evaluate Pharmacokinetics, Safety, and Activity

What this Trial Is About

Researchers are studying the effects of nipocalimab, a drug given by IV infusion, on children and adolescents aged 2 to less than 18 years who have generalized myasthenia gravis gMG and have not responded sufficiently to standard treatments. The study aims to assess the safety, tolerability, and how nipocalimab behaves in the body, including its impact on total serum immunoglobulin G IgG levels. The study is open-label and uncontrolled, focusing on pediatric patients with this condition globally, and specifically for ages 8 to less than 18 years at US sites. Participants are divided into two groups based on age children aged 2 to less than 12 years and adolescents aged 12 to less than 18 years. They will receive nipocalimab once every two weeks for 24 weeks. After completing the 24-week treatment, participants have the option to join a long-term extension LTE to continue receiving the drug. The study tracks various outcomes including IgG levels, safety events, and drug pharmacokinetics over a period of up to three years. During the study, participants will undergo regular blood tests and clinical evaluations to monitor IgG levels, adverse events, and other health markers. Researchers will also assess changes in muscle strength, quality of life, fatigue, and overall disease severity using various scores and questionnaires. Safety will be closely monitored through laboratory tests, vital signs, physical exams, and recording of any adverse events. The study duration includes up to three years of follow-up to evaluate long-term effects and immune responses to the medication.

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