Neuromyelitis Optica Spectrum Disorder (NMOSD)
Conditions
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)
Interventions
DRUGIMC-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.
DRUGmycophenolate mofetil， MMF
daily oral 0.2g
Sponsors
ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of relapse-free patients | Up to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary Contactjinhua zhou
Outcome results
None listed