NCT06557174

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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)

Conditions

• Neuromyelitis Optica Spectrum Disorder (NMOSD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-11-10
• Completion: 2026-07-10
• First posted: 2024-08-16
• Last updated: 2024-08-16