Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-29 @ 8:25 AM
Study NCT ID:
NCT07168161
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}], 'ancestors': [{'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719787', 'term': 'BDB001'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, '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': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-02-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)', 'timeFrame': 'Week 24'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients achieving disease sustained remission assessed by Birmingham Vasculitis Activity Score (BVAS)', 'timeFrame': 'Week 48'}, {'measure': 'Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study', 'timeFrame': 'Week 48'}, {'measure': 'Percentage of Participants With BVAS of 0 at Week 4', 'timeFrame': 'Week 4'}, {'measure': 'In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR)', 'timeFrame': 'Baseline, Week 24 and Week 48'}, {'measure': 'In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Urinary albumin:creatinine ratio (UACR)', 'timeFrame': 'Baseline, Week 4, 24 and 48'}, {'measure': 'Glucocorticoid-induced Toxicity as Measured by Change From Baseline in the GTI', 'timeFrame': 'Baseline, Week 24 and 48'}, {'measure': 'Cumulative dose of glucocorticoids', 'timeFrame': 'Week 24 and 48'}, {'measure': 'Change from baseline in the Vasculitis Damage Index (VDI)', 'timeFrame': 'Baseline, Week 24 and 48'}, {'measure': 'Change From Baseline in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36', 'timeFrame': 'Baseline, Week 24 and 48'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ANCA Associated Vasculitis (AAV)']}, 'descriptionModule': {'briefSummary': 'The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years old≤Age≤75 years old, male or female;\n2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；\n3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab；\n4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；\n5. Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\\^2；\n6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；\n\nExclusion Criteria:\n\n1. Active tuberculosis infection;\n2. alveolar hemorrhage requiring pulmonary ventilation support；\n3. Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis,anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis；\n4. HBsAg positive,or HBcAb positive and HBV-DNA positive；\n5. Received CYC within 3 months before the first administration or Received rituximab(RTX) within 12 months before the first administration；\n6. Received glucocorticoid shock therapy within 4 weeks before the first administration；\n7. Received an oral daily dose of a GC of \\> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration；\n8. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration；\n9. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;\n10. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;\n11. Pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT07168161', 'briefTitle': 'BDB-001 Phase III Trial in ANCA-Associated Vasculitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Staidson (Beijing) Biopharmaceuticals Co., Ltd'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis', 'orgStudyIdInfo': {'id': 'STS-BDB001-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BDB-001 injection group', 'description': 'BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.', 'interventionNames': ['Drug: BDB-001 injection', 'Drug: Cyclophosphamide', 'Biological: Rituximab', 'Drug: Azathioprine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisone group', 'description': 'BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.', 'interventionNames': ['Drug: Cyclophosphamide', 'Biological: Rituximab', 'Drug: Azathioprine', 'Drug: Prednisone']}], 'interventions': [{'name': 'BDB-001 injection', 'type': 'DRUG', 'description': 'Intravenously administered', 'armGroupLabels': ['BDB-001 injection group']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Intravenously administered', 'armGroupLabels': ['BDB-001 injection group', 'Prednisone group']}, {'name': 'Rituximab', 'type': 'BIOLOGICAL', 'description': 'Intravenously administered', 'armGroupLabels': ['BDB-001 injection group', 'Prednisone group']}, {'name': 'Azathioprine', 'type': 'DRUG', 'description': 'Intravenously administered', 'armGroupLabels': ['BDB-001 injection group', 'Prednisone group']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Intravenously administered', 'armGroupLabels': ['Prednisone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tian Xinping', 'role': 'CONTACT', 'email': 'tianxp@126.com', 'phone': '+86 13691165939'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Zuo', 'role': 'CONTACT', 'email': 'zuolimd@yeah.net', 'phone': '+86 010-88326666'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen Tang, Doctor', 'role': 'CONTACT', 'email': 'tangwen@126.com', 'phone': '+86 010-82266699'}, {'role': 'CONTACT', 'email': 'haiyanli1027@hotmail.com'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 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