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

Phase 1

Not yet recruiting

• Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD)
• Interventions: Drug: IMC-002; Drug: mycophenolate mofetil， MMF

• Registration Number: NCT06557174
• Lead Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Brief 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)

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Study Start: 2024-10-10
• Primary Completion: 2025-11-10
• Study Completion: 2026-07-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 116

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMC-002	IMC-002	intravenous injection of 0.8mg/kg、1.2mg/kg
mycophenolate mofetil， MMF	mycophenolate mofetil， MMF	mycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral.

Primary Outcome Measures

Name	Time	Method
Proportion of relapse-free patients	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
Time to first relapse (TFR)	Up to Week 24
Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study	Baseline (Day -28 to Day -1) to Week 24	The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability