A new study testing the safety and efficacy of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD) is now open.
The multicenter, prospective, real-world study will compare the effect of inebilizumab in the acute phase of the disease to oral immunosuppressant.
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The study aims to recruit 50 patients who are seropositive for antiaquaporin-4 antibodies and who are in the acute phase of the disease at around 10 centers in China. Patients were all at least 18 years of age.
Participants will be divided into 2 groups. Those in the first group will be given 300 mg of intravenous inebilizumab plus intravenous methylprednisolone on day 1 and intravenous inebilizumab only on day 15, while those in the second group will be given intravenous methylprednisolone plus be initiated on oral immunosuppressants (azathioprine or mycolate mofetil).
The primary outcome measure will be any change in Expanded Disability Status Scale score from baseline to month 6.
Secondary outcome measures will include the percentage of participants with disability improvements, time to first relapse, the number of new and/or enlarging T2 hyperintense lesions as detected by magnetic resonance imaging, any change in the timed 25 foot walk time from baseline, the number of rescue treatments related to NMOSD attacks, and any change from baseline in the low-contrast visual acuity, levels of aquaporin-4 antibody titers, glial fibrillary acidic protein in the serum, and retinal nerve fiber layer loss.
The study is not yet recruiting participants. It is estimated to start on July 20, 2023, and be completed on July 31, 2025.
NMOSD is a rare chronic inflammatory disease of the central nervous system characterized by the presence of autoantibodies against the astrocyte aquaporin-4 water channel in most cases.
Inebilizumab is a monoclonal antibody against CD19 indicated for the treatment of adults with antiaquaporin-4 antibody-positive NMOSD.
Reference
Inebilizumab in acute neuromyelitis optica spectrum disorders. US National Library of Medicine. Last updated June 6, 2023. Accessed June 9, 2023.
