Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT04302103
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2020-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C035529', 'term': 'RC-18'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline', 'timeFrame': 'week 24', 'description': 'QMG score=Quantitative Myasthenia Gravis Score'}], 'secondaryOutcomes': [{'measure': 'The average variation of clinical absolute score for myasthenia gravis of the twelfth and twenty-fourth weeks compared to Clinical absolute score for myasthenia gravis of baseline', 'timeFrame': 'week 12，24', 'description': 'It is best that the assessors in each center are fixed during the study.'}, {'measure': 'The average variation of QMG score of the twelfth week compared to the OMG scores of baseline', 'timeFrame': 'week 12', 'description': 'QMG score=Quantitative Myasthenia Gravis Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily signed informed consent ;\n2. Patient diagnosed with systemic myasthenia gravis according to The following conditions.\n3. Seropositive at screening for AChR（Acetylcholine receptor）-Ab or MuSK（Muscle specific tyrosine kinase）-Ab;\n4. MGFA（Myasthenia Gravis Foundation of America） Clinical classification Ⅱ-IIIb;\n5. QMG score≥8,and QMG score\\>2 in four or more items;\n6. Maintained any one of the stable standard treatment programs in the trial protocol.\n\nExclusion Criteria:\n\n1. Combined autoimmune diseases, such as systemic lupus erythematosus,rheumatoid arthritis, systemic sclerosis and so on,except for hypothyroidism and hyperthyroidism;\n2. Abnormal laboratory parameters need to be excluded, including but not limited to:\n3. Immunosuppressive agents except agents of standard treatment programs were used within one month prior to randomization.;\n4. Use of biological agents for targeted therapy within 6 months prior to randomization;\n5. Intravenous immunoglobulin therapy or plasma exchange therapy within 2 months before randomization;\n6. Active infection during screening(For example,herpes zoster,HIV antibody positive,active tuberculosis,etc);\n7. Currently suffering from active hepatitis or severe liver lesions and history;\n8. Diabetics with poor blood sugar control:HbAlc\\>9.0% or FBG≥11.1mmol/L;\n9. Currently having a thymic tumor ,or had a thymectomy within 6 months prior to screening;\n10. Received live vaccines within 3 months before randomization,or scheduled to administer vaccine during the trial;\n11. Malignant tumor patients;\n12. Allergic to human biological preparations;\n13. Have participated in any clinical trial within 28 days before randomization,or in 5 times half-life period of the drugs of any clinical trial(taking the longer time).\n14. Pregnant , lactating women and men or women who have birth plans during the research;\n15. Having alcohol or drug abuse that affect the experimental conditions;\n16. Investigator considers candidates not appropriating for the study.'}, 'identificationModule': {'nctId': 'NCT04302103', 'briefTitle': 'A Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'RemeGen Co., Ltd.'}, 'officialTitle': 'A Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Systemic Myasthenia Gravis', 'orgStudyIdInfo': {'id': '18C011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RC18 160mg', 'description': 'Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.', 'interventionNames': ['Biological: RC18 160mg']}, {'type': 'EXPERIMENTAL', 'label': 'RC18 240 mg', 'description': 'Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.', 'interventionNames': ['Biological: RC18 240 mg']}], 'interventions': [{'name': 'RC18 160mg', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection', 'armGroupLabels': ['RC18 160mg']}, {'name': 'RC18 240 mg', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection', 'armGroupLabels': ['RC18 240 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xianhao Xu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RemeGen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}