Neuromyelitis Optica Spectrum Disorders
Conditions
Brief summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
Interventions
BIOLOGICALPlacebo
Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.
BIOLOGICALRC18 160 mg
In the Phase B,the researchers can adjust the dose of RC18 according to the subjects' willingness and recurrence, but the maximum dose of single dose should not exceed 320g.
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity. * EDSS 0-7.5 * Clinical evidence of at least 2 relapses within the first two years of randomization and/ or 1 relapse within the first one year of randomization * Consent to use effective contraception during the study period (women of childbearing age) * Voluntarily signed informed consent
Exclusion criteria
* Abnormal laboratory parameters need to be excluded, including but not limited to: * Currently suffering from active hepatitis or serious liver disease and medical history * Patients were treated with rituximab or other monoclonal antibodies within 6 months prior to randomization . * Any concomitant disease other than neuromyelitis optica（NMO）/ neuromyelitis optica Spectrum disorders（NMOSD）that required treatment with lucocorticoid. * pregnant , lactating women and men or women who have birth plans during the research; * Have a history of allergic reaction to contrast agent for parenteral administration and human biological medicines. * Receipt of intravenous immune globulin （ IVIG） within 28 days prior to randomization. * Receipt of any of the following prior to randomization: Azathioprine,Cyclosporin, Methotrexate Mitoxantrone,Cyclophosphamide,Tocilizumab,Tacrolimus,Mycophenolate,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .If the patients taking leflunomide and teriflunomide,they should need to take colestyramine for elution. * Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking shorter time ). * The patients have severe psychiatric symptoms and are not compatible with clinical studies * Malignant tumor patients ; * patients experienced any of the following events within 12 weeks before screening : myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association class IV heart failure * Patients can't accept magnetic resonance imaging inspection during the trial. * Infection with herpes zoster or HIV virus at the screening; * The anti-hepatitis C virus （anti-HCV） of patients show positive; * Investigator considers candidates not appropriating for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first relapse after randomization | 144 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144 | 144 weeks | The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments. |
| Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144 | week 4,8,12,24,36,48,60,72,96,120,144 | — |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORxianhao Xu
Beijing Hospital
Outcome results
None listed