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

NCT ID: NCT06557174

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2026-07-10

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)

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IMC-002

intravenous injection of 0.8mg/kg、1.2mg/kg

Group Type: EXPERIMENTAL

IMC-002

Intervention Type: DRUG

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

mycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral.

Group Type: ACTIVE_COMPARATOR

mycophenolate mofetil， MMF

Intervention Type: DRUG

daily oral 0.2g

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.

Intervention Type: DRUG

mycophenolate mofetil， MMF

daily oral 0.2g

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

jinhua zhou

Role: CONTACT

jinhua.zhou@immuneonco.com

02138016387

Other Identifiers

IMC002-N-01

Identifier Type: -

Identifier Source: org_study_id