Clinical Trial

Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

Study acronym: STARGlu-NMO
Not Yet Recruiting Phase 3
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Summary
Neuromyelitis optica spectrum disorder (NMOSD) is a central nervous system autoimmune condition mainly involving the spinal cord, optic nerves, and area postrema. The anti-aquaporin-4 (AQP4)-Immunoglobulin G (IgG) is a specific biomarker for NMOSD. Glucocorticoids(GCs) are used as first-line treatment for NMOSD. Oral glucocorticoids tapering is always suggested following the pused therapy in the maintenance phase. Inebilizumab, a humanized monoclonal antibody targeting CD19, has been proven effective in preventing NMOSD relapses. This study aims to evaluate and compare the efficacy and differences between glucocorticoids slow-tapering and rapid-tapering strategies combined with inebilizumab in preventing relapses in AQP4-IgG-seropositive NMOSD patients following an acute attack, with the goal of determining the optimal approach to steroid tapering and discontinuation after initiation of inebilizumab.
Trial Details
NCT Number NCT07132398
Lead Sponsor Tianjin Medical University General Hospital
Conditions Neuromyelitis Optica (NMO), Neuromyelitis Optica Spectrum Disorders (NMOSD)
Enrollment 170 participants
Start Date 2025-09-01
Primary Completion 2027-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-20