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NOT YET RECRUITING
NCT06557174
PHASE1/PHASE2

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

Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

mycophenolate mofetil, MMF

daily oral 0.2g