Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naĆÆve AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) patients, while assessing its impact on EDSS score improvement during acute-phase treatment. The study will further explore treatment-related biomarkers, including dynamic changes in: immunoglobulin levels, lymphocyte subset profiles, serum AQP4-IgG titers, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NFL) levels. Study Design:This is a single-center, randomized, open-label, prospective clinical study planning to enroll 25 treatment-naĆÆve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.
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The change in the average daily dose of corticosteroids between the two groups during the follow-up period compared to randomization (i.e., baseline
Timeframe: Baseline, Week 2, Week 4, Week 12, Week 24
Time to first clinical relapse
Timeframe: From the date of randomization (baseline) to the date of first documented clinical relapse (as defined by protocol criteria), assessed up to 24 weeks.