Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

Sponsor
Feng Jinzhou
Study ID
NCT06068829
Status
Unknown

Conditions

  • Neuromyelitis Optica Spectrum Disorders

Eligibility Criteria

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

Interventions

  • Inebilizumab — DRUG
    Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP.
  • Rituximab(RTX) — DRUG
    RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP.

Study Details

To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.

Key Dates

Start date
Oct 20, 2023
Status verified
Sep 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Exposed group 1
    Intravenous methylprednisolone (IVMP) plus Inebilizumab
  • Arm: Exposed group 2
    IVMP plus Rituximab (RTX)

Primary Outcome Measure

Change in Expanded Disability Status Scale Score (EDSS) from baseline. [ Time Frame: 12 months ]

Central Contacts

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