Study of Ofatumumab Treatment in Adults with AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder

What this Trial Is About

Researchers are evaluating the efficacy and safety of ofatumumab in adult patients with neuromyelitis optica spectrum disorder NMOSD who are AQP4-IgG seropositive. NMOSD is a rare and serious disorder that mainly affects adults and involves an immune response against the aquaporin-4 water channel. Monoclonal antibodies targeting CD20 have been effective in preventing relapses, and this study aims to assess ofatumumab, a fully humanized anti-CD20 antibody approved for multiple sclerosis, for NMOSD treatment in China. In this open-label, single-arm, multicenter pilot study, participants receive ofatumumab 20 mg0.4 ml as a subcutaneous injection at baseline, Day 7, Day 14, and then monthly for a total of 48 weeks. The first four doses are administered at the study center, while subsequent doses are given at home with a nurse conducting online interviews to supervise the infusion. Participants will be monitored through various assessments including changes in annual relapse rate, disability status EDSS, lesion burden on MRI, optic coherence tomography measures, circulating B cell subsets, immune landscape, biochemical indicators, functional questionnaires, and adverse events. These evaluations occur at baseline and at multiple time points up to 12 months. The studys total duration for each participant is approximately 48 weeks, with continuous safety and efficacy monitoring throughout this period.

Ofatumumab in AQP4-IgG Seropositive NMOSD