BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Sponsor
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study ID
NCT07168161
Phase
PHASE3
Status
Recruiting
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Conditions

  • ANCA Associated Vasculitis (AAV)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BDB-001 injection — DRUG
    Intravenously administered
  • Cyclophosphamide — DRUG
    Intravenously administered
  • Rituximab — BIOLOGICAL
    Intravenously administered
  • Azathioprine — DRUG
    Intravenously administered
  • Prednisone — DRUG
    Intravenously administered

Study Details

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

Key Dates

Start date
Nov 10, 2025
Status verified
Apr 2026
Primary completion
Apr 16, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BDB-001 injection group
    BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
  • Active Comparator: Prednisone group
    BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.

Primary Outcome Measure

The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS) [ Time Frame: Week 24 ]

Central Contacts

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