BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Recruiting now · Phase 3

Conditions studied: ANCA Associated Vasculitis (AAV)

In brief

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

Key facts

Study ID

NCT07168161

Run by

Staidson (Beijing) Biopharmaceuticals Co., Ltd

People needed

300

Starts

2025-11-10

Expected to finish

2028-02-29

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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；

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.

Where it is running

• Hunan Provincial People's Hospital — Changsha, Hunan, China (enrolling)
• Peking University Third Hospital — Beijing, Beijing Municipality, China
• Peking university Shenzhen Hospital — Shenzhen, Guangdong, China
• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China
• Peking University First Hospital — Beijing, Beijing Municipality, China
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China
• Guangdong General Hospital — Guangzhou, Guangdong, China
• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China
• Meizhou People's Hospital — Meizhou, Guangdong, China
• Yuebei People's Hospital — Shaoguan, Guangdong, China
• Guangdong Provincial People's Hospital — Shenzhen, Guangdong, China
• Peking University International Hospital — Beijing, Beijing Municipality, China
• Liuzhou People's Hospital — Liuzhou, Guangxi, China
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi Zhuang Autonomous Region (gzar), China
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China
• Cangzhou City People's Hospital — Cangzhou, Hebei, China
• The Second Hospital of Hebei Medical University City:Shijiazhuang — Shijiazhuang, Hebei, China
• Kailuan General Hospital — Tangshan, Hebei, China
• The Second Affiliated Hospital of Harbin — Harbin, Heilongjiang, China
• The First Affiliated Hospital of Henan University of science and Technology — Luoyang, Henan, China
• Peking University People's Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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