BDB-001 Phase III Trial in ANCA-Associated Vasculitis
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
Staidson (Beijing) Biopharmaceuticals Co., Ltd
300 participants
Nov 10, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- 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 Criteria11
- 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.
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Interventions
Intravenously administered
Intravenously administered
Intravenously administered
Intravenously administered
Intravenously administered
Locations(50)
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NCT07168161