About this trial
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
Eligibility criteria
Qualifiers
Age 18 to 70 years, inclusive, at the time of informed consent
Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
Confirmation of NMOSD diagnosis with AQP4+ antibodies
The EDSS score should be ≤7.0
Disqualifiers
Have received rituximab or other anti-CD20 drugs treatment within 6 months
Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.
Females who are pregnant or lactating.
Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).
Trial design
Treatments tested in this trial
- IMC-002
- mycophenolate mofetil, MMF