Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-02 @ 12:31 PM
Study NCT ID:
NCT06454357
Status:
RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of B007 in the Treatment of Pemphigus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010392', 'term': 'Pemphigus'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects：Complete remission with minimal treatment', 'timeFrame': 'Approximately36 weeks'}], 'secondaryOutcomes': [{'measure': 'The number of relapses of the disease', 'timeFrame': 'Approximately 1 years'}, {'measure': 'Proportion of subjects：Partial remission', 'timeFrame': 'Approximately 36weeks'}, {'measure': 'Change: PDAI（Pemphigus disease area index）', 'timeFrame': 'Approximately 36 weeks'}, {'measure': 'CR/PR Proportion of subjects：Complete remission /Partial remission', 'timeFrame': 'Approximately 52 weeks'}, {'measure': 'DoR （Duration of Response）', 'timeFrame': 'Approximately 1 years'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Approximately 1 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pemphigus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who voluntarily participate in this study and sign informed consent form;\n2. Subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases;\n3. Subjects with first diagnosis or relapse;\n4. Subjects who have the ability to follow the study protocol as determined by the investigator.\n\nExclusion Criteria:\n\n1. Subjects diagnosed with prescribed diseases;\n2. Since the diagnosis of pemphigus, Disease duration\\>4 years;\n3. Subjects using prescribed drugs;\n4. Presence of a specified disease or history of disease;\n5. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;\n6. A history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs;\n7. Subjects who participate in another interventional clinical trial at a specified time before randomization;\n8. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;\n9. Pregnant and lactating women;\n10. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to the prescribed time after the last dose.\n\n Women who are considered fertile by the investigator must have negative serum pregnancy tests before starting the drug;\n11. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within specified time after the last dose, or male subjects who plan to donate sperm at a specified time during the trial or after the last dose.\n12. Other conditions deemed unsuitable for participation in this study by the researchers.'}, 'identificationModule': {'nctId': 'NCT06454357', 'briefTitle': 'A Clinical Study of B007 in the Treatment of Pemphigus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Jiaolian Drug Research and Development Co., Ltd'}, 'officialTitle': 'A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Pemphigus.', 'orgStudyIdInfo': {'id': 'SPH-B007-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B007', 'interventionNames': ['Drug: B007']}], 'interventions': [{'name': 'B007', 'type': 'DRUG', 'description': 'B007：high dose/low dose: Subcutaneous injection was administered on days 1 and 15', 'armGroupLabels': ['B007']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hang Li', 'role': 'CONTACT'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Zhan', 'role': 'CONTACT'}], 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanyan Feng', 'role': 'CONTACT'}], 'facility': "Chengdu Second People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Li', 'role': 'CONTACT'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sheng Fang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chao Ji', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruzeng Xue', 'role': 'CONTACT'}], 'facility': 'Dermatology Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhu Shen', 'role': 'CONTACT'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Jinan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Furen Zhang', 'role': 'CONTACT'}], 'facility': 'Shandong First Medical University-Affiliated Skin Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meng Pan', 'role': 'CONTACT'}], 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Tao', 'role': 'CONTACT'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianguo Li', 'role': 'CONTACT'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Hang Li', 'role': 'CONTACT', 'email': 'bdyyec@163.com', 'phone': '0086-010-66119025'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiaolian Drug Research and Development Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shanghai Pharmaceuticals Holding Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}