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BDB-001 Phase III Trial in ANCA-Associated Vasculitis

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Interventions: Azathioprine (Drug), BDB-001 injection (Drug), Cyclophosphamide (Drug), Prednisone (Drug), Rituximab (Biological) to Azathioprine (Drug), BDB-001 injection (Drug), Cyclophosphamide (Drug), Prednisone (Drug), Rituximab (Drug)v6
  2. Trial sites expanded: 60 → 65 locationsv5
  3. Study sites: 50 to 60
    • Eligibility criteria expanded, about 53 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 29, 2025 to Nov 10, 2025
    • Site details revised at 50 of 50 sites
    v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07168161
Lead Sponsor Staidson (Beijing) Biopharmaceuticals Co., Ltd
Conditions
(from sponsor)		 ANCA Associated Vasculitis (AAV)
Related terms Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov