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

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD)

Treatments: Drug: mycophenolate mofetil， MMF; Drug: IMC-002

Study type: Interventional

Funder types: Other

Identifiers

NCT06557174

IMC002-N-01

Details and patient eligibility

About

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

Full 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)

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

IMC-002

Experimental group

Description:

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

Treatment:

Drug: IMC-002

mycophenolate mofetil， MMF

Active Comparator group

Description:

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

Treatment:

Drug: mycophenolate mofetil， MMF