Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease

NCT07159893 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	First Affiliated Hospital of Wenzhou Medical University
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	25
Start date	2025-09
Completion	2026-09

Conditions

• Neuromyelitis Optica
• Autoimmune Diseases
• Demyelinating Autoimmune Diseases, CNS

Interventions

• Inebilizumab + Rapid Steroid Tapering group
• Inebilizumab + Standard Steroid Tapering group

Primary outcomes

• The change in the average daily dose of corticosteroids between the two groups during the follow-up period compared to randomization (i.e., baseline — Baseline, Week 2, Week 4, Week 12, Week 24
  Record the corticosteroid dose for patients at randomization (baseline) and during the follow-up period
• Time to first clinical relapse — From the date of randomization (baseline) to the date of first documented clinical relapse (as defined by protocol criteria), assessed up to 24 weeks.
  Accurately document the time of symptom onset in patients.