Status:
RECRUITING
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
Lead Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions:
ANCA Associated Vasculitis (AAV)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 u...
Eligibility Criteria
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
- 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；
- Received CYC within 3 months before the first administration or Received rituximab(RTX) 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.
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07168161
Start Date
November 10 2025
End Date
February 29 2028
Last Update
November 25 2025
Active Locations (50)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
4
Peking University International Hospital
Beijing, Beijing Municipality, China, 102206