A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients

A Phase Ib/III Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients

The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.

This is a phase Ib/III study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg dose level, Phase III study is a multi-center, randomized, double-blind, positive control study to evaluate the safety and efficacy of IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD)

Inclusion Criteria:

• 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 clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening

Exclusion Criteria:

• 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).