Study of Ublituximab Treatment in Children and Teenagers With Relapsing Multiple Sclerosis

What this Trial Is About

Researchers are studying ublituximab in children and teenagers aged 10 to less than 18 years who have relapsing forms of multiple sclerosis RMS and weigh between 25 and 40 kilograms. The study aims to understand how the drug behaves in the body pharmacokinetics and pharmacodynamics, compare ublituximab to another treatment called fingolimod, and evaluate the long-term safety and effectiveness of ublituximab. The study has three parts Part A focuses on how ublituximab is processed in the body and its effects over 24 weeks Part B compares ublituximab with fingolimod and placebo over 96 weeks and Part C is an extension phase to observe long-term safety and efficacy for up to 168 weeks. Ublituximab is given as an intravenous infusion, while fingolimod and placebo capsules are taken orally. Participants will undergo various assessments including blood tests to measure drug levels and immune cells, magnetic resonance imaging MRI scans to monitor brain lesions, and evaluations of relapse rates and disability status. Safety will be monitored by tracking adverse events and changes in mental health. The study lasts several years, with ongoing evaluations to understand the impact of treatments on pediatric RMS symptoms and progression.

Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis