Inectolizumab With Steroid Optimization in Newly Treated NMOSD

Sponsor
First Affiliated Hospital of Wenzhou Medical University
Study ID
NCT07159893
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Inebilizumab + Rapid Steroid Tapering group — DRUG
    Drug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ；Day 20 (Week 2): Second dose ；Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \& Tapering:Day 6-19: 60 mg daily；Day 20: 60 mg every other day (EOD) ；Day 34: 30 mg EOD → Day 48: 15 mg EOD → Day 62: 10 mg EOD → Day 76: 5 mg EOD → Day 90: Discontinue Route: Oral
  • Inebilizumab + Standard Steroid Tapering group — DRUG
    Drug 1: Inebilizumab Generic Name: Inebilizumab Formulation: Injection (Intravenous) Dose: 300 mg Frequency:Day 6 (Week 0): First dose ；Day 20 (Week 2): Second dose ；Week 24: Third dose Route: Intravenous infusion Drug 2: Prednisone Generic Name: Prednisone Formulation: Tablet (Oral) Dose \& Tapering:Day 6-34: 60 mg daily;Day 34: 60 mg EOD → Day 62: 30 mg EOD → Day 90: 15 mg EOD → Day 118: 10 mg EOD → Day 146: 5 mg EOD → Day 174:Discontinue; Route: Oral

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inebilizumab with Rapid Steroid Tapering group
    Participants receive: 1. Acute-phase: Methylprednisolone 1.0g IV daily (Days 1-5) 2. Maintenance-phase: * Day 6: Prednisone 60mg po daily + Inebilizumab 300mg IV * Day 20: Second inebilizumab 300mg IV + Prednisone reduced to 60mg po every other day 3. Steroid tapering schedule:Day 34→30mg EOD → Day 48→15mg EOD → Day 62→10mg EOD → Day 76→5mg EOD → Day 90→Discontinue 4. Long-term: Third inebilizumab 300mg IV at Week 24
  • Active Comparator: Inebilizumab with Standard Steroid Tapering group
    Participants receive: 1. Acute-phase (Days 1-5):Methylprednisolone 1.0g IV daily 2. Maintenance-phase: * Day 6: Prednisone 60mg po daily +First inebilizumab 300mg IV * Day 20: Second inebilizumab 300mg IV+Continue prednisone 60mg po daily until Day 34 3. Steroid Tapering Schedule: Day 34→60mg EOD → Day 62→30mg EOD → Day 90→15mg EOD → Day 118→10mg EOD → Day 146→5mg EOD → Day 174→Discontinue 4. Long-term: Third inebilizumab 300mg IV at Week 24

Primary Outcome Measure

The change in the average daily dose of corticosteroids between the two groups during the follow-up period compared to randomization (i.e., baseline [ Time Frame: Baseline, Week 2, Week 4, Week 12, Week 24 ]

Central Contacts

Related Studies