Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
NCT ID: NCT05197842
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
93 participants
INTERVENTIONAL
2022-02-22
2025-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
BDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide
BDB-001 injection
Intravenously administered
Cyclophosphamide
Intravenously administered
Glucocorticoids
Orally administered
Group B
BDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide
BDB-001 injection
Intravenously administered
Cyclophosphamide
Intravenously administered
Glucocorticoids
Orally administered
Group C
Standard dose glucocorticoids in combination with cyclophosphamide
Cyclophosphamide
Intravenously administered
Glucocorticoids
Orally administered
Group D
BDB-001 injection low dose in combination with cyclophosphamide
BDB-001 injection
Intravenously administered
Cyclophosphamide
Intravenously administered
Group E
BDB-001 injection high dose in combination with cyclophosphamide
BDB-001 injection
Intravenously administered
Cyclophosphamide
Intravenously administered
Interventions
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BDB-001 injection
Intravenously administered
Cyclophosphamide
Intravenously administered
Glucocorticoids
Orally administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；
* Newly diagnosed or relapsed GPA or MPA that requires treatment with cyclophosphamide(CYC) and glucocorticoids(GCs)；
* Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；
* Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2；
* At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；
Exclusion Criteria
* Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage requiring pulmonary ventilation support, rapid-onset mononeuritis multiplex or central nervous system involvement；
* 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；
* HBsAg positive,or HBcAb positive and HBV-DNA positive；
* Received CYC within 3 months before the first administration or Received rituximab(RTX) within 12 months before the first administration；
* Received glucocorticoid shock therapy within 4 weeks before the first administration；
* Received an oral daily dose of a GC of \> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration；
* Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration；
* Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;
* Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;
* Pregnant or lactating.
18 Years
75 Years
ALL
No
Sponsors
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Staidson (Beijing) Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Minghui Zhao, Postdoc
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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The Second hospital Of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang Autonomous Region (gzar), China
The Second hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital,Tongji Medical college of Hust
Wuhan, Hubei, China
Xiangya Hospital Central South University (Nephrology Department)
Changsha, Hunan, China
Xiangya Hospital Central South University(Rheumatism Immunity Branch)
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia Hui Autonomous Region(NHAR), China
Zhongshan hospital,Fudan University
Shanghai, Shanghai Municipality, China
Xijing Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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STS-BDB001-07
Identifier Type: -
Identifier Source: org_study_id
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