Actively Recruiting
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
Led by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Updated on 2026-04-23
300
Participants Needed
60
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
- Newly diagnosed or relapsed GPA or MPA requiring treatment with full starting dose prednisone plus cyclophosphamide/azathioprine or rituximab
- Positive test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO)
- Estimated glomerular filtration rate (eGFR) of at least 15 mL/min/1.73 m²
- Presence of at least 1 major item, or at least 3 non-major items, or at least the 2 renal items on Birmingham Vasculitis Activity Score (BVAS)
You will not qualify if you...
- Active tuberculosis infection
- Alveolar hemorrhage requiring pulmonary ventilation support
- History of any malignancy within 5 years except completely resected basal cell carcinoma or carcinoma in situ without recurrence or metastasis
- Other known multi-system autoimmune diseases including eosinophilic granulomatosis with polyangiitis, systemic lupus erythematosus, IgA vasculitis, rheumatoid vasculitis, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis
- Positive hepatitis B surface antigen or positive hepatitis B core antibody with detectable HBV-DNA
- Received cyclophosphamide within 3 months or rituximab/B-cell antibodies within 12 months before first dose
- Received glucocorticoid shock therapy within 4 weeks before first dose
- Taken daily oral prednisone equivalent over 10 mg for more than 6 weeks before first dose
- Received anti-tumor necrosis factor or other biological treatments within 12 weeks before first dose
- Received continuous dialysis for 12 weeks or more or dialysis within 1 week before first dose
- Received intravenous immunoglobulin or plasma exchange within 4 weeks before first dose
- Pregnant or lactating
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 60 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Not Yet Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Not Yet Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Not Yet Recruiting
4
Peking University International Hospital
Beijing, Beijing Municipality, China, 102206
Not Yet Recruiting
5
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Not Yet Recruiting
6
Peking University First Hospital
Beijing, Beijing Municipality, China, 710000
Not Yet Recruiting
7
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
8
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Not Yet Recruiting
9
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
10
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
11
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
12
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Not Yet Recruiting
13
Meizhou People's Hospital
Meizhou, Guangdong, China, 514031
Not Yet Recruiting
14
Yuebei People's Hospital
Shaoguan, Guangdong, China, 512026
Not Yet Recruiting
15
Guangdong Provincial People's Hospital
Shenzhen, Guangdong, China, 510080
Not Yet Recruiting
16
Peking university Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Not Yet Recruiting
17
Liuzhou People's Hospital
Liuzhou, Guangxi, China, 545006
Not Yet Recruiting
18
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
19
Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang Autonomous Region (gzar), China, 530016
Not Yet Recruiting
20
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Not Yet Recruiting
21
Cangzhou City People's Hospital
Cangzhou, Hebei, China, 061000
Not Yet Recruiting
22
The Second Hospital of Hebei Medical University City:Shijiazhuang
Shijiazhuang, Hebei, China, 050004
Not Yet Recruiting
23
Kailuan General Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
24
The Second Affiliated Hospital of Harbin
Harbin, Heilongjiang, China, 150086
Not Yet Recruiting
25
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China, 471003
Not Yet Recruiting
26
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
27
Tongji Hospital,Tongji Medical college of Hust
Wuhan, Hubei, China, 100005
Not Yet Recruiting
28
Yichang Central People's Hospital
Yichang, Hubei, China, 443003
Not Yet Recruiting
29
General Hospital of Hunan University of Medicine
Changde, Hunan, China, 415000
Not Yet Recruiting
30
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
Actively Recruiting
31
Xiangya Hospital Central South University (Nephrology Department)
Changsha, Hunan, China, 410008
Not Yet Recruiting
32
Xiangya Hospital Central South University(Rheumatism Immunity Branch)
Changsha, Hunan, China, 410008
Not Yet Recruiting
33
General Hospital of Hunan University of Medicine
Huaihua, Hunan, China, 418000
Not Yet Recruiting
34
Zhuzhou Central Hospital
Zhuzhou, Hunan, China, 412007
Not Yet Recruiting
35
Nanjing Gulou Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
36
Nanjing University School of Medicine Affiliated Gulou Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
37
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221002
Not Yet Recruiting
38
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
39
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
40
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
Not Yet Recruiting
41
Affiliated Hospital of Yanbian University (Yanbian Hospital)
Yanbian, Jilin, China, 133000
Not Yet Recruiting
42
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China, 110004
Not Yet Recruiting
43
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, China, 010050
Not Yet Recruiting
44
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Not Yet Recruiting
45
Weifang People's Hospital
Weifang, Shandong, China, 261041
Not Yet Recruiting
46
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
47
Zhongshan hospital,Fudan University
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
48
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Not Yet Recruiting
49
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030032
Not Yet Recruiting
50
Xijing Hospital
Xi’an, Shanxi, China, 710032
Not Yet Recruiting
51
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
52
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
53
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
54
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
Not Yet Recruiting
55
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China, 650032
Not Yet Recruiting
56
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
57
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
58
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
59
People's Hospital of Lishui
Lishui, Zhejiang, China, 323000
Not Yet Recruiting
60
The Affiliated Hospital of the Medical School of Ningbo University
Ningbo, Zhejiang, China, 315010
Not Yet Recruiting
Research Team
A
Aiping Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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