ANCA Associated Vasculitis (AAV)Phase 3NCT07168161

BDB-001 Phase III Trial in ANCA-Associated Vasculitis

A Phase 3 study testing BDB-001 injection, Cyclophosphamide and Rituximab in people with ANCA Associated Vasculitis (AAV), run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 65 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: ANCA Associated Vasculitis (AAV)
What is being tested?: BDB-001 injection, Cyclophosphamide and Rituximab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 65 sitesChina
Study dates: 10 Nov 2025to 29 Feb 2028
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 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；

Who cannot join

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；

Show all 12Show fewer

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.

Trial locations and contacts

65 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aiping Sun contact

+86 010-67519614

sunaiping@staidson.com

City, postcode or hospital

Sites recruiting now only

65 sites in 1 country

China65 sites, 65 recruiting

Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Tian Xinping, +86 13691165939, tianxp@126.com
Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Li Zuo, +86 010-88326666, zuolimd@yeah.net
Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Wen Tang, Doctor, +86 010-82266699, tangwen@126.com
haiyanli1027@hotmail.com
Not yet recruiting
Peking University International Hospital
Beijing, Beijing Municipality, 102206
Yu Feng, +86 13681265231, yufengevert1@sina.com
Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Yuehong Li, +86 010-56112345, lyha01051@btch.edu.cn
Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 710000
Minghui Zhao, 13501243815, mhzhao@bjmu.edu.cn
Not yet recruiting
Cangzhou City People's Hospital
Cangzhou, Hebei, 061000
Jie Hao, 0317-3076120, hjwxd@163.com
Not yet recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Wenpeng Cui, +86 0431-81136566, wenpengcui@163.com
Not yet recruiting
General Hospital of Hunan University of Medicine
Changde, Hunan, 415000
Xiang Ren, +86 0736-7788112, renxiang_88@163.com
Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
Qinghua Zeng, +86 13975882946, 18502865@qq.com
Recruiting
Xiangya Hospital Central South University (Nephrology Department)
Changsha, Hunan, 410008
Xiao Xiangcheng, +86 13787312910, 1376785378@qq.com
Not yet recruiting
Xiangya Hospital Central South University(Rheumatism Immunity Branch)
Changsha, Hunan, 410008
Zhou Yaou, +86 13787252412, 376124490@qq.com
Not yet recruiting
The Third People's Hospital of Chengdu
Chengdu, Sichuan, 610031
Guisen Li, 18981838253, guisenli@163.com
Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Fang Liu, +86 028-85422114, liufangfh@163.com
Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Jing Zhu, +86 028-87393999, 335782136@qq.com
Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Xiaohui Liao, +86 023-63693379, 1263201771@qq.com
Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Yi Yang, 023-68811360, yangyilyx@163.com
Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Yang Li, 020-83882222, Ly20240227@126.com
Not yet recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510120
Lie Dai, +86 020-81332199, liedai2004@163.com
Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Yan Zha, +86 0851-85922979, zhayan72@126.com
Not yet recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Han Fei, +86 13968193317, hanf8876@163.com
Not yet recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jing Xue, +86 0571-87783886, jingxue@zju.edu.cn
Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Yiwen Li, +86 87666666, yiwen1962@163.com
Not yet recruiting
The Second Affiliated Hospital of Harbin
Harbin, Heilongjiang, 150086
Xuanyi Du, +86 0451-86605222, dxy_shennei@126.com
Not yet recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, 010050
Jianrong Zhao, +86 0471-3451120, zjr13848129952@163.com
Not yet recruiting
General Hospital of Hunan University of Medicine
Huaihua, Hunan, 418000
Liang Song, +86 0745-2383694, 18674558206@163.com
Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Rong Wang, +86 0531-87938911, wangronggcp@126.com
Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Jing Wang, 0871-63639921, wjing1981@163.com
Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Yanfei Chen, +86 0931-8625200, chyanfei70@163.com
Not yet recruiting
People's Hospital of Lishui
Lishui, Zhejiang, 323000
Jianyun Peng, 0578-2780028, Pengjianyun1@163.com
Not yet recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Jianfei Li, +86 0772-2662012, 2313385913@qq.com
Not yet recruiting
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, 471003
Xiaofei Shi, +86 13663884080, sxf64817332@163.com
Not yet recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Ke Zhang, 0753-2202723, zhangke@mzrmyy.com
Not yet recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Aimin Zhong, +86 0791-86895550, Aiminzhong@126.com
Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Rui Chen, +86 0791-88692748, tcmclinic@163.com
Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xin wang Duan, 13970085678, 13970085678@163.com
Not yet recruiting
Nanjing Gulou Hospital
Nanjing, Jiangsu, 210000
Rongfu Zhou, rfzhoucn@163.com
Not yet recruiting
Nanjing University School of Medicine Affiliated Gulou Hospital
Nanjing, Jiangsu, 210000
Lingyun Sun, +86 13705186409, lingyunsun2012@163.com
Not yet recruiting
Jiang Su Province Hospital
Nanjing, Jiangsu, 210029
Qiang Wang, 13913889877, jerrytortoise@163.com
Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Zhenhua Yang, +86 0771-5356533, 593456108@qq.com
Not yet recruiting
Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang Autonomous Region (gzar), 530016
Xinxiang Huang, +86 0771-5356566, nnhxx_china@163.com
Not yet recruiting
The Affiliated Hospital of the Medical School of Ningbo University
Ningbo, Zhejiang, 315010
Wen Qin, 0574-87085588, qinwenlx@126.com
Not yet recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jingyuan Xie, +86 021-64370045, nephroxie@163.com
Not yet recruiting
Zhongshan hospital,Fudan University
Shanghai, Shanghai Municipality, 200032
Jiang Lindi, +86 13701973875, jiang.lindi@zs-hospital.sh.cn
Not yet recruiting
Yuebei People's Hospital
Shaoguan, Guangdong, 512026
Hai Wang, 0751-6913281, 13826353566@163.com
Not yet recruiting
Shengjing Hospital of China Medical University
Shengyang, Liaoning, 110004
Zhou Hua, +86 18940251607, zhouh@sj-hospital.org
Not yet recruiting
Guangdong Provincial People's Hospital
Shenzhen, Guangdong, 510080
Lixia Xu, +86 020-81332367, lixia.xu123@outlook.com
Not yet recruiting
Peking university Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zuying Xiong, +86 0755-83923333, xiongzy2005@163.com
Not yet recruiting
The Second Hospital of Hebei Medical University City:Shijiazhuang
Shijiazhuang, Hebei, 050004
Huaying Pei, +86 0311-66002999, huayingpei@163.com
Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Zhichun Liu, 13771994276, lzchun5190@sina.com
Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Liyun Zhang, +86 0351-8379573, liyunzhang_cnto@163.com
Not yet recruiting
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030032
Xiaoxia Wang, +86 0351-3365400, 13753123937@163.com
Not yet recruiting
Kailuan General Hospital
Tangshan, Hebei, 063000
Jierui Wang, 0315-3022243, 15133965508@163.com
Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Suhua Li, +86 0991-4362391, lisuhuanh@sina.com
Not yet recruiting
Weifang People's Hospital
Weifang, Shandong, 261041
Jingjing Ma, +86 0536-8192599, wfmjj001@163.com
Not yet recruiting
Tongji Hospital,Tongji Medical college of Hust
Wuhan, Hubei, 100005
Xu Gang, +86 13507181312, xugang@tjh.tjmu.edu.cn
Not yet recruiting
Xijing Hospital
Xi’an, Shanxi, 710032
Zheng Zhaohui, +86 13571924267, zhengzhimmu@163.com
Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061
Wanhong Lu, +86 13087581233, lu_wanhong@126.com
Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Liping Shao, +86 0592-2132222, shaolepingGCP@yeah.net
Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Dongmei Zhou, 0516-85802999, 13813283017@163.com
Not yet recruiting
Affiliated Hospital of Yanbian University (Yanbian Hospital)
Yanbian, Jilin, 133000
Jingchun Jin, +86 0433 2660170, jingchun680928@163.com
Not yet recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443003
Xiaoqiang Hou, +86 0717-6496666, hxqhjz@163.com
Jianying Huang, 18971116998, znyylcsy@126.com
Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zhao Zhanzheng, +86 13938525666, zhanzhengzhao@zzu.edu.cn
Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Shengyun Liu, 13837192659, fccliusy2@zzu.edu.cn
Not yet recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007
Zhenhua Wen, +86 0731-28561122, 151728544@qq.com
Not yet recruiting

Other trials in China

About this study

Official title: 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

Conditions: ANCA Associated Vasculitis (AAV)
Being tested: BDB-001 injection, Cyclophosphamide, Rituximab, Azathioprine, Prednisone
Medical subject headings: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BDB-001 injectionDrug
Intravenously administered
CyclophosphamideDrug
Intravenously administered
RituximabDrug
Intravenously administered
AzathioprineDrug
Intravenously administered
PrednisoneDrug
Intravenously administered

Study groups in NCT07168161
Study group	Role	What they receive
BDB-001 injection group	Experimental	BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo. Receives: Drug: BDB-001 injection; Drug: Cyclophosphamide; Drug: Rituximab; Drug: Azathioprine
Prednisone group	Active comparator	BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone. Receives: Drug: Cyclophosphamide; Drug: Rituximab; Drug: Azathioprine; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)
Measured: Week 24

Secondary outcomes (9)

The proportion of patients achieving disease sustained remission assessed by Birmingham Vasculitis Activity Score (BVAS)
Measured: Week 48
Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study
Measured: Week 48
Percentage of Participants With BVAS of 0 at Week 4
Measured: Week 4
In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR)
Measured: 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)
Measured: Baseline, Week 4, 24 and 48
Glucocorticoid-induced Toxicity as Measured by Change From Baseline in the GTI
Measured: Baseline, Week 24 and 48
Cumulative dose of glucocorticoids
Measured: Week 24 and 48
Change from baseline in the Vasculitis Damage Index (VDI)
Measured: Baseline, Week 24 and 48
Change From Baseline in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36
Measured: Baseline, Week 24 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Nov 202529 Feb 2028

First posted11 Sep 2025
Study start10 Nov 2025
Primary completion16 Apr 2027 (estimated)
Study completion29 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ANCA Associated Vasculitis (AAV)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07168161
Sponsor's protocol ID: STS-BDB001-10
Status last verified: Apr 2026
First submitted: 4 Sep 2025
Last updated: 13 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Aiping Sun

+86 010-67519614

sunaiping@staidson.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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ANCA Associated Vasculitis (AAV)
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Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined With Immunosuppressants in the Treatment of Refractory Autoimmune Diseases
Systemic Lupus Erthematosus, Systemic Sclerosis (SSc)
RecruitingPhase 1/2
Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
Systemic Lupus Erthematosus, Systemic Sclerosis (SSc)
RecruitingPhase 2
Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis
ANCA-Associated Glomerulonephritis (AAGN), ANCA-Associated Vasculitis (AAV)
Not yet recruitingEarly Phase 1
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
IgA Nephropathy (IgAN), Membranous Nephropathy

All ANCA Associated Vasculitis (AAV) trials