Open-Label Phase 2 Study of Intravenous Inebilizumab in Children Aged 2 to Under 18 With Neuromyelitis Optica Spectrum Disorder Positive for AQP4 Antibodies

What this Trial Is About

Researchers are evaluating inebilizumab in a Phase 2, open-label, multicenter study involving pediatric participants aged 2 to under 18 years with recently active neuromyelitis optica spectrum disorder NMOSD who test positive for autoantibodies against aquaporin-4 AQP4-IgG. The study aims to assess how the body processes the drug pharmacokinetics, its biological effects pharmacodynamics, and its safety in this population. About 15 participants will receive inebilizumab through intravenous infusion over a 28-week treatment period. The entire trial duration per participant is around 80 weeks, which includes up to 4 weeks for screening, 9 visits during the treatment period, and approximately 4 follow-up visits over 52 weeks. Safety evaluations will be conducted regularly throughout the study. Participants will have multiple assessments including blood tests to measure drug levels and immune cell counts, vital signs monitoring, and evaluations of disease activity like time to relapse and relapse rates. Quality of life and disability status will also be measured. The study monitors adverse events and other health indicators from the first day through week 80 to understand the drugs effects and safety over time.

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder