Last updated: November 24, 2023
Sponsor: RemeGen Co., Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Multiple Sclerosis
Treatment
RC18 160 mg
Placebo
Clinical Study ID
NCT03330418
C009NMOSDCLLI
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Meet the 2015 international consensus diagnostic criteria for Neuromyelitis OpticaSpectrum 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 randomizationand/ or 1 relapse within the first one year of randomization
- Consent to use effective contraception during the study period (women of childbearingage)
- Voluntarily signed informed consent
Exclusion
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 monthsprior to randomization .
- Any concomitant disease other than neuromyelitis optica(NMO)/ neuromyelitis opticaSpectrum 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 administrationand 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,andPatients discontinued more than 5 times the half-life of the drug before they couldget into the group .If the patients taking leflunomide and teriflunomide,they shouldneed to take colestyramine for elution.
- Have participated in any clinical trial in the first 28 days of the initial screeningor 5 times half-life period of the study compound (taking shorter time ).
- The patients have severe psychiatric symptoms and are not compatible with clinicalstudies
- 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 HeartAssociation 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.
Study Design
Total Participants: 166
Treatment Group(s): 2
Primary Treatment: RC18 160 mg
Phase: 3
Study Start date:
January 29, 2018
Estimated Completion Date:
December 31, 2025
Connect with a study center
Beijing Hospital
Beijing, Beijing
ChinaActive - Recruiting
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