drugset / Trial / NCT07168161
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2025-11-10
- Primary completion
- 2027-04-16
- Completion
- 2028-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisone | Other / unclassified | — | Intravenous |
| Subject | Resiquimod | Small molecule | — | Intravenous |
| Background | Azathioprine | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |