Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis
1 other identifier
interventional
93
1 country
22
Brief Summary
The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection substitution of glucocorticoid in patients with ANCA-associated vasculitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2022
Typical duration for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedStudy Start
First participant enrolled
February 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2025
CompletedAugust 7, 2025
August 1, 2025
3.1 years
December 2, 2021
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients achieving disease complete remission or partial remission assessed by Birmingham Vasculitis Activity Score (BVAS)
12 weeks
Secondary Outcomes (11)
The proportion of patients achieving disease complete remission assessed by Birmingham Vasculitis Activity Score (BVAS)
12 weeks
Change from baseline in the Birmingham Vasculitis Activity Score (BVAS)
4 weeks、8 weeks、12 weeks
Change from baseline in the Vasculitis Damage Index (VDI)
12 weeks
Change from baseline in Estimated glomerular filtration rate (eGFR)、Urinary albumin:creatinine ratio (UACR)、Urine erythrocyte
4 weeks、8 weeks、12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
0-24weeks
- +6 more secondary outcomes
Study Arms (5)
Group A
EXPERIMENTALBDB-001 injection low dose plus reduced dose glucocorticoids in combination with cyclophosphamide
Group B
EXPERIMENTALBDB-001 injection high dose plus reduced dose glucocorticoids in combination with cyclophosphamide
Group C
ACTIVE COMPARATORStandard dose glucocorticoids in combination with cyclophosphamide
Group D
EXPERIMENTALBDB-001 injection low dose in combination with cyclophosphamide
Group E
EXPERIMENTALBDB-001 injection high dose in combination with cyclophosphamide
Interventions
Eligibility Criteria
You may qualify if:
- years old≤Age≤75 years old, male or female;
- 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；
You may not qualify if:
- Active tuberculosis infection;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
The Second hospital Of Anhui Medical University
Hefei, Anhui, 230601, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University International Hospital
Beijing, Beijing Municipality, 102206, China
Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang Autonomous Region (gzar), 530016, China
The Second hospital of Hebei Medical University
Shijiazhuang, Hebei, 050004, China
The Third hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, 471003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital,Tongji Medical college of Hust
Wuhan, Hubei, 100005, China
Xiangya Hospital Central South University (Nephrology Department)
Changsha, Hunan, 410008, China
Xiangya Hospital Central South University(Rheumatism Immunity Branch)
Changsha, Hunan, 410008, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410205, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, 110004, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia Hui Autonomous Region(NHAR), 750003, China
Zhongshan hospital,Fudan University
Shanghai, Shanghai Municipality, 200032, China
Xijing Hospital
Xi’an, Shanxi, 710032, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minghui Zhao, Postdoc
Peking University First Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2021
First Posted
January 20, 2022
Study Start
February 22, 2022
Primary Completion
March 19, 2025
Study Completion
March 19, 2025
Last Updated
August 7, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share