Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
Study NCT ID:
NCT07172360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients achieving an Assessment of disease activity (signs and symptoms) in ankylosing spondylitis 20% improvement (ASAS20) in response at week 12 of treatment.', 'timeFrame': 'week 12'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Active Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject understands and voluntarily signs the informed consent form (ICF) and is willing and able to comply with the study protocol;\n* The subject is between 18 and 70 years of age (including borderline values) at the time of signing the ICF, regardless of gender;\n* The subject has been diagnosed with AS according to the 1984 New York Revised Criteria for Ankylosing Spondylitis\n\nExclusion Criteria:\n\n* Those who may be allergic to VC005, similar drugs or their excipients.\n* Individuals who have undergone organ transplantation in the past and require continuous use of immunosuppressants.\n* Those who, for any reason, are considered by the investigator to be unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT07172360', 'briefTitle': 'Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu vcare pharmaceutical technology co., LTD'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Active Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'VC005-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VC005 Tablets Low Dose groups', 'interventionNames': ['Drug: VC005 tablets']}, {'type': 'EXPERIMENTAL', 'label': 'VC005 Tablets High Dose groups', 'interventionNames': ['Drug: VC005 tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'VC005 Tablets Placebo groups', 'interventionNames': ['Drug: VC005 Tablets Placebo']}], 'interventions': [{'name': 'VC005 tablets', 'type': 'DRUG', 'description': 'VC005 groups repeat administration for 48 weeks', 'armGroupLabels': ['VC005 Tablets High Dose groups', 'VC005 Tablets Low Dose groups']}, {'name': 'VC005 Tablets Placebo', 'type': 'DRUG', 'description': 'VC005 placebo groups repeat administration for 48 weeks', 'armGroupLabels': ['VC005 Tablets Placebo groups']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Zhanguo Li', 'role': 'CONTACT', 'email': 'Zgli99@aliyun.com', 'phone': '13910713924'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'xiaojuan lai', 'role': 'CONTACT', 'email': 'lai_xiaojuan@vcarepharmatech.com', 'phone': '15358160458'}], 'overallOfficials': [{'name': 'Zhanguo Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Xu Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu vcare pharmaceutical technology co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}