The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
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
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).
Parallel
IMC-002
Drugintravenous injection: Weekly administered for a period of first 4 weeks, then rest for 20 weeks. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued.
mycophenolate mofetil， MMF
Drugdaily oral 0.2g
Proportion of relapse-free patients
Time to first relapse (TFR)
Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
