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Taking people in ChinaPhase 3

Tests BDB-001 injection in adults with ANCA-associated vasculitis

Tests BDB-001 injection, with or without standard drugs, in adults with ANCA-associated vasculitis.

Plain-language title generated from the registry record
Registry title: BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Key facts

Where
Beijing, Cangzhou, Changchun, Changde, Changsha, Chengdu, Chongqing, Guangzhou, Guiyang, Hangzhou, Harbin, Hohhot, Huaihua, Jinan, Kunming, Lanzhou, Lishui, Liuzhou, Luoyang, Meizhou, Nanchang, Nanjing, Nanning, Ningbo, Shanghai, Shaoguan, Shengyang, Shenzhen, Shijiazhuang, Suzhou, Taiyuan, Tangshan, Ürümqi, Weifang, Wuhan, Xi'an, Xi’an, Xiamen, Xuzhou, Yanbian, Yichang, Zhengzhou, and Zhuzhou, ChinaSee the 64 sites
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT07168161, who can take part

Where in China

  • Beijing Tsinghua Changgung HospitalBeijing, ChinaNot yet recruiting
  • Peking Union Medical College HospitalBeijing, ChinaNot yet recruiting
  • Peking University First HospitalBeijing, ChinaNot yet recruiting
  • Peking University International HospitalBeijing, ChinaNot yet recruiting
  • Peking University People's HospitalBeijing, ChinaNot yet recruiting
  • Peking University Third HospitalBeijing, ChinaNot yet recruiting
  • Cangzhou City People's HospitalCangzhou, ChinaNot yet recruiting
  • The Second Hospital of Jilin UniversityChangchun, ChinaNot yet recruiting
  • General Hospital of Hunan University of MedicineChangde, ChinaNot yet recruiting
  • Hunan Provincial People's HospitalChangsha, ChinaTaking people
  • Xiangya Hospital Central South University (Nephrology Department)Changsha, ChinaNot yet recruiting
  • Xiangya Hospital Central South University(Rheumatism Immunity Branch)Changsha, ChinaNot yet recruiting
  • Sichuan Provincial People's HospitalChengdu, ChinaNot yet recruiting
  • The Third People's Hospital of ChengduChengdu, ChinaNot yet recruiting
  • West China Hospital of Sichuan UniversityChengdu, ChinaNot yet recruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting
  • The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting
  • Guangdong General HospitalGuangzhou, ChinaNot yet recruiting
  • Sun Yat Sen Memorial Hospital of Sun Yat sen UniversityGuangzhou, ChinaNot yet recruiting
  • Guizhou Provincial People's HospitalGuiyang, ChinaNot yet recruiting
  • The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaNot yet recruiting
  • The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNot yet recruiting
  • Zhejiang Provincial People's HospitalHangzhou, ChinaNot yet recruiting
  • The Second Affiliated Hospital of HarbinHarbin, ChinaNot yet recruiting
  • Affiliated Hospital of Inner Mongolia Medical UniversityHohhot, ChinaNot yet recruiting
  • General Hospital of Hunan University of MedicineHuaihua, ChinaNot yet recruiting
  • Shandong Provincial HospitalJinan, ChinaNot yet recruiting
  • The First People's Hospital of Yunnan ProvinceKunming, ChinaNot yet recruiting
  • The First Hospital of Lanzhou UniversityLanzhou, ChinaNot yet recruiting
  • People's Hospital of LishuiLishui, ChinaNot yet recruiting
  • Liuzhou People's HospitalLiuzhou, ChinaNot yet recruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaNot yet recruiting
  • Meizhou People's HospitalMeizhou, ChinaNot yet recruiting
  • Jiangxi Provincial People's HospitalNanchang, ChinaNot yet recruiting
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaNot yet recruiting
  • The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaNot yet recruiting
  • Jiang Su Province HospitalNanjing, ChinaNot yet recruiting
  • Nanjing Gulou HospitalNanjing, ChinaNot yet recruiting
  • Nanjing University School of Medicine Affiliated Gulou HospitalNanjing, ChinaNot yet recruiting
  • Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous RegionNanning, ChinaNot yet recruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaNot yet recruiting
  • The Affiliated Hospital of the Medical School of Ningbo UniversityNingbo, ChinaNot yet recruiting
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaNot yet recruiting
  • Zhongshan Hospital,Fudan UniversityShanghai, ChinaNot yet recruiting
  • Yuebei People's HospitalShaoguan, ChinaNot yet recruiting
  • Shengjing Hospital of China Medical UniversityShengyang, ChinaNot yet recruiting
  • Guangdong Provincial People's HospitalShenzhen, ChinaNot yet recruiting
  • Peking University Shenzhen HospitalShenzhen, ChinaNot yet recruiting
  • The Second Hospital of Hebei Medical University City:ShijiazhuangShijiazhuang, ChinaNot yet recruiting
  • The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaNot yet recruiting
  • Shanxi Bethune HospitalTaiyuan, ChinaNot yet recruiting
  • The Second Hospital of Shanxi Medical UniversityTaiyuan, ChinaNot yet recruiting
  • Kailuan General HospitalTangshan, ChinaNot yet recruiting
  • The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, ChinaNot yet recruiting
  • Weifang People's HospitalWeifang, ChinaNot yet recruiting
  • Tongji Hospital Tongji Medical College of HustWuhan, ChinaNot yet recruiting
  • Xijing hospitalXi'an, ChinaNot yet recruiting
  • The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, ChinaNot yet recruiting
  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaNot yet recruiting
  • The affiliated hospital of xuzhou medical universityXuzhou, ChinaNot yet recruiting
  • Affiliated Hospital of Yanbian University (Yanbian Hospital)Yanbian, ChinaNot yet recruiting
  • Yichang Central People's HospitalYichang, ChinaNot yet recruiting
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNot yet recruiting
  • Zhuzhou Central HospitalZhuzhou, ChinaNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Trial code
NCT07168161
Record updated
13 August 2026
Original description
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 rituximabRead full original descriptionShow less

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

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

Inclusion: 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；.

Exclusion: 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; 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; Active tuberculosis infection; alveolar hemorrhage requiring pulmonary ventilation support；; 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；; Pregnant or lactating.

ClinicalTrials.gov NCT07168161