Phase III Evaluation of Satralizumab Treatment for Children Aged 2 to 11 with AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder

What this Trial Is About

Researchers are evaluating the pharmacokinetics of satralizumab in children aged 2 to 11 years who have anti-aquaporin-4 AQP4 antibody-positive neuromyelitis optica spectrum disorder NMOSD. The study also observes the drugs efficacy, safety, tolerability, and pharmacodynamics in a descriptive way due to the small number of participants. This is a phase III treatment trial sponsored by Hoffmann-La Roche. Participants will receive satralizumab by subcutaneous injection with dosing schedules depending on body weight cohorts. Doses are given at Weeks 0, 2, 4, and then every 4 weeks thereafter. Treatment lasts for at least 48 weeks, after which participants may enter an optional extension period to continue satralizumab treatment. During the study, participants will have regular assessments including blood sampling to measure satralizumab levels and pharmacokinetic parameters up to Week 48. Researchers will monitor relapse rates, disability scores, visual acuity, pain levels, quality of life, and adverse events throughout treatment. The total participation duration spans at least 48 weeks with ongoing safety and efficacy evaluations.

A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)