A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMC-002, mycophenolate mofetil， MMF.
- Who it may be relevant to
- Registry conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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)
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
Primary outcome measures
- Proportion of relapse-free patients [Time frame: Up to Week 24]
Secondary outcome measures (2)
- Time to first relapse (TFR) [Time frame: Up to Week 24]
- Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study [Time frame: Baseline (Day -28 to Day -1) to Week 24]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06557174 · IMC002-N-01