Status:
UNKNOWN
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
Neuromyelitis Optica Spectrum Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03330418
Start Date
January 29 2018
End Date
December 1 2025
Last Update
November 27 2023
Active Locations (1)
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1
Beijing Hospital
Beijing, Beijing Municipality, China