Clinical Trial

BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Recruiting Phase 3
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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
Protocol Amendment History 1 change
notable Trial sites expanded: 60 -> 65 locations 2026-07-29
Trial Details
NCT Number NCT07168161
Lead Sponsor Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions ANCA Associated Vasculitis (AAV)
Enrollment 300 participants
Start Date 2025-11-10
Primary Completion 2027-04-16 (estimated)
Study Completion 2028-02-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-13