Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

Sponsor
Xuanwu Hospital, Beijing
Study ID
NCT05891379
Status
Recruiting
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Conditions

  • Neuromyelitis Optica Spectrum Disorder

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 inelizumab is given during IVMP.
  • oral immunosuppressant — DRUG
    Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP.

Study Details

This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

Key Dates

Start date
Jul 9, 2024
Status verified
Jun 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Exposed group
    intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab
  • Arm: Non-exposed group
    IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine)

Primary Outcome Measure

Change in Expanded Disability Status Scale (EDSS) score from baseline [ Time Frame: 6 months ]

Central Contacts

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