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A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2024-10-10
Completion Date
2026-07-10
Last Updated
2024-08-16
Healthy Volunteers
No
Interventions
IMC-002
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.
mycophenolate mofetil, MMF
daily oral 0.2g