Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-02-23 @ 12:11 AM
Study NCT ID:
NCT03330418
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2017-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009471', 'term': 'Neuromyelitis Optica'}], 'ancestors': [{'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035529', 'term': 'RC-18'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2017-10-31', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first relapse after randomization', 'timeFrame': '144 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144', 'timeFrame': '144 weeks', 'description': 'The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.'}, {'measure': 'Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144', 'timeFrame': 'week 4,8,12,24,36,48,60,72,96,120,144'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromyelitis Optica Spectrum Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity.\n* EDSS 0-7.5\n* 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\n* Consent to use effective contraception during the study period (women of childbearing age)\n* Voluntarily signed informed consent\n\nExclusion Criteria:\n\n* Abnormal laboratory parameters need to be excluded, including but not limited to:\n* Currently suffering from active hepatitis or serious liver disease and medical history\n* Patients were treated with rituximab or other monoclonal antibodies within 6 months prior to randomization .\n* Any concomitant disease other than neuromyelitis optica（NMO）/ neuromyelitis optica Spectrum disorders（NMOSD）that required treatment with lucocorticoid.\n* pregnant , lactating women and men or women who have birth plans during the research;\n* Have a history of allergic reaction to contrast agent for parenteral administration and human biological medicines.\n* Receipt of intravenous immune globulin （ IVIG） within 28 days prior to randomization.\n* 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.\n* 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 ).\n* The patients have severe psychiatric symptoms and are not compatible with clinical studies\n* Malignant tumor patients ;\n* 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\n* Patients can't accept magnetic resonance imaging inspection during the trial.\n* Infection with herpes zoster or HIV virus at the screening;\n* The anti-hepatitis C virus （anti-HCV） of patients show positive;\n* Investigator considers candidates not appropriating for the study."}, 'identificationModule': {'nctId': 'NCT03330418', 'briefTitle': 'A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'RemeGen Co., Ltd.'}, 'officialTitle': 'A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders.', 'orgStudyIdInfo': {'id': 'C009NMOSDCLLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo Comparator', 'description': '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.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'RC18 160 mg', 'description': '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.', 'interventionNames': ['Biological: RC18 160 mg']}], 'interventions': [{'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.', 'armGroupLabels': ['Placebo Comparator']}, {'name': 'RC18 160 mg', 'type': 'BIOLOGICAL', 'description': "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.", 'armGroupLabels': ['RC18 160 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianhao Xu', 'role': 'CONTACT', 'email': 'bjyyxcc@bjhmoh.cn', 'phone': '010-65282171'}], 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Binghua Xiao', 'role': 'CONTACT', 'email': 'xiaosir522@163.com', 'phone': '86-010-58076833'}], 'overallOfficials': [{'name': 'xianhao Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RemeGen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}