BDB-001 Phase III Trial in ANCA-Associated Vasculitis (NCT07168161) | Clinical Trial Compass
RecruitingPhase 3
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
China300 participantsStarted 2025-11-10
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)；
✕. 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；
What they're measuring
1
The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS)
✕. 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；