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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
116
intravenous 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.
daily oral 0.2g
Proportion of relapse-free patients
Time frame: Up to Week 24
Time to first relapse (TFR)
Time frame: Up to Week 24
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
Time frame: Baseline (Day -28 to Day -1) to Week 24
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