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Inectolizumab With Steroid Optimization in Newly Treated NMOSD

NCT07159893 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-08

No results posted yet for this study

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-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.

Conditions

Interventions

DRUG

Inebilizumab + Rapid Steroid Tapering group

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

DRUG

Inebilizumab + Standard Steroid Tapering group

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

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Xu Zhang, Bachelor · First Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-05-31
Completion
2026-09-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159893 on ClinicalTrials.gov