A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
NCT ID: NCT03330418
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
166 participants
INTERVENTIONAL
2018-01-29
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Comparator
Participants received placebo weekly administered subcutaneously for 48 times in the double-blind treatment period.Once the participants relapse,they should advance to the open phase.All participants were treated with the test drugs.
Placebo
Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.
RC18 160 mg
Patients received the test group RC18 160mg weekly administered subcutaneously for 48 times.Starting with the forty-ninth dose,the trial went into the open phase . All participants were treated with the test drugs.
RC18 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.
Interventions
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Placebo
Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.
RC18 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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xianhao Xu
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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C009NMOSDCLLI
Identifier Type: -
Identifier Source: org_study_id