BDB-001 Phase III Trial in ANCA-Associated Vasculitis
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
1 other identifier
interventional
300
1 country
60
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2025
60 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
September 4, 2025
CompletedFirst Posted
Study publicly available on registry
September 11, 2025
CompletedStudy Start
First participant enrolled
November 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 29, 2028
April 23, 2026
April 1, 2026
1.4 years
September 4, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)
Week 24
Secondary Outcomes (9)
The proportion of patients achieving disease sustained remission assessed by Birmingham Vasculitis Activity Score (BVAS)
Week 48
Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study
Week 48
Percentage of Participants With BVAS of 0 at Week 4
Week 4
In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR)
Baseline, Week 24 and Week 48
In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Urinary albumin:creatinine ratio (UACR)
Baseline, Week 4, 24 and 48
- +4 more secondary outcomes
Study Arms (2)
BDB-001 injection group
EXPERIMENTALBDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
Prednisone group
ACTIVE COMPARATORBDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
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 a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab；
- 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;
- alveolar hemorrhage requiring pulmonary ventilation support；
- History of any malignancy of any organ system within 5 years prior to the first dose, except for basal cell carcinoma of the skin or carcinoma in situ (e.g., cervical or breast carcinoma in situ) that has been completely resected and shows no evidence of local recurrence or metastasis.
- 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) or other B-cell antibody 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 (60)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Peking University International Hospital
Beijing, Beijing Municipality, 102206, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Peking University First Hospital
Beijing, Beijing Municipality, 710000, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Meizhou People's Hospital
Meizhou, Guangdong, 514031, China
Yuebei People's Hospital
Shaoguan, Guangdong, 512026, China
Guangdong Provincial People's Hospital
Shenzhen, Guangdong, 510080, China
Peking university Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang Autonomous Region (gzar), 530016, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Cangzhou City People's Hospital
Cangzhou, Hebei, 061000, China
The Second Hospital of Hebei Medical University City:Shijiazhuang
Shijiazhuang, Hebei, 050004, China
Kailuan General Hospital
Tangshan, Hebei, 063000, China
The Second Affiliated Hospital of Harbin
Harbin, Heilongjiang, 150086, 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
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
General Hospital of Hunan University of Medicine
Changde, Hunan, 415000, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Xiangya Hospital Central South University (Nephrology Department)
Changsha, Hunan, 410008, China
Xiangya Hospital Central South University(Rheumatism Immunity Branch)
Changsha, Hunan, 410008, China
General Hospital of Hunan University of Medicine
Huaihua, Hunan, 418000, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
Nanjing Gulou Hospital
Nanjing, Jiangsu, 210000, China
Nanjing University School of Medicine Affiliated Gulou Hospital
Nanjing, Jiangsu, 210000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Affiliated Hospital of Yanbian University (Yanbian Hospital)
Yanbian, Jilin, 133000, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, 110004, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, 010050, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Weifang People's Hospital
Weifang, Shandong, 261041, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Zhongshan hospital,Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030032, China
Xijing Hospital
Xi’an, Shanxi, 710032, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
People's Hospital of Lishui
Lishui, Zhejiang, 323000, China
The Affiliated Hospital of the Medical School of Ningbo University
Ningbo, Zhejiang, 315010, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minghui Zhao, M.D.
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2025
First Posted
September 11, 2025
Study Start
November 10, 2025
Primary Completion (Estimated)
April 16, 2027
Study Completion (Estimated)
February 29, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04