Inectolizumab With Steroid Optimization in Newly Treated NMOSD
Status:
NOT_YET_RECRUITING
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
Summary
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-nave 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-nave, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.
Phase:
NA
Details
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University