Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD

Sponsor
Tianjin Medical University General Hospital
Study ID
NCT07132398
Phase
PHASE3
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

  • Neuromyelitis Optica (NMO)
  • Neuromyelitis Optica Spectrum Disorders (NMOSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Slow-tapering glucocorticoids + Inebilizumab — DRUG
    Slow-tapering glucocorticoids+Inebilizumab arm: A 300 mg intravenous infusion of inebilizumab will be administered on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks thereafter. Prednisone will be initiated at a daily dose of 60 mg as concomitant therapy with inebilizumab. The prednisone dose will be tapered as follows: a reduction of 5 mg every 2 weeks until reaching 20 mg/day(Week 16); thereafter, a reduction of 5 mg every 4 weeks until discontinuation (a total duration of 32 weeks for combined inebilizumab and glucocorticoids therapy).
  • Rapid-tapering glucocorticoids + Inebilizumab — DRUG
    Rapid-tapering glucocorticoids+Inebilizumab arm: A 300 mg intravenous infusion of inebilizumab will be administered on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks thereafter. Prednisone will be initiated at a daily dose of 60 mg as concomitant therapy with inebilizumab, with a tapering schedule of 5 mg reduction per week until discontinuation (a total duration of 12 weeks for combined inebilizumab and glucocorticoids therapy).

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

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

Arms

  • Active Comparator: Slow-tapering glucocorticoids + Inebilizumab arm
  • Active Comparator: Rapid-tapering glucocorticoids + Inebilizumab arm

Primary Outcome Measure

First adjudicated relapse event within 54 weeks [ Time Frame: Baseline, 54 Weeks ]

Central Contacts