Phase 2 Study of Inebilizumab IV to Assess Safety and Effects in Children Ages 2 to Under 18 With Generalized Myasthenia Gravis

What this Trial Is About

Researchers are evaluating the pharmacokinetics PK, pharmacodynamics PD, safety, and tolerability of inebilizumab in children aged 2 to less than 18 years with generalized myasthenia gravis gMG. This Phase 2 open-label study aims to understand how the drug behaves in the body and affects immune cells in this pediatric population. The study also monitors for any adverse effects experienced by participants. Inebilizumab will be administered intravenously IV to all participants. The study follows a single group design without placebo comparison. Treatment and monitoring occur over a period extending up to 78 weeks, including assessment of drug concentration and immune cell counts up to Week 52 and safety and clinical outcomes through Week 78. Participants will undergo regular evaluations including blood tests to measure drug levels, immune cell counts, and laboratory safety parameters. Clinical assessments include measures of muscle strength, activities of daily living, quality of life, and fatigue. The study tracks adverse events and changes in vital signs throughout the participation. The total study period lasts until Week 78, allowing detailed long-term safety and efficacy monitoring in children with gMG.

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)