Inectolizumab With Steroid Optimization in Newly Treated NMOSD

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-naïve 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-naïve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.

NCT Number	NCT07159893
Lead Sponsor	First Affiliated Hospital of Wenzhou Medical University
Conditions	Neuromyelitis Optica, Autoimmune Diseases, Demyelinating Autoimmune Diseases, CNS
Enrollment	25 participants
Start Date	2025-09
Primary Completion	2026-05 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-09-08