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BDB-001 Phase III Trial in AN...

BDB-001 Phase III Trial in ANCA-Associated Vasculitis

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2028-02-29

Brief Summary

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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

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Detailed Description

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Conditions

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ANCA Associated Vasculitis (AAV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BDB-001 injection group

BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.

Group Type EXPERIMENTAL

BDB-001 injection

Intervention Type DRUG

Intravenously administered

Cyclophosphamide

Intervention Type DRUG

Intravenously administered

Rituximab

Intervention Type BIOLOGICAL

Intravenously administered

Azathioprine

Intervention Type DRUG

Intravenously administered

Prednisone group

BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

Intravenously administered

Rituximab

Intervention Type BIOLOGICAL

Intravenously administered

Azathioprine

Intervention Type DRUG

Intravenously administered

Prednisone

Intervention Type DRUG

Intravenously administered

Interventions

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BDB-001 injection

Intravenously administered

Intervention Type DRUG

Cyclophosphamide

Intravenously administered

Intervention Type DRUG

Rituximab

Intravenously administered

Intervention Type BIOLOGICAL

Azathioprine

Intravenously administered

Intervention Type DRUG

Prednisone

Intravenously administered

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 18 years old≤Age≤75 years old, male or female;
2. Diagnosis of granulomatosis with polyangiitis(GPA) or microscopic polyangiitis(MPA)；
3. Newly diagnosed or relapsed GPA or MPA that requires treatment with a full starting dose of prednisone plus cyclophosphamide/azathioprine or rituximab；
4. Positive test for anti-proteinase 3(PR3) or anti-myeloperoxidase (MPO)；
5. Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2；
6. At least 1 major item, or at least 3 non-major items, or at least the 2 renal items on BVAS；

Exclusion Criteria

1. Active tuberculosis infection;
2. alveolar hemorrhage requiring pulmonary ventilation support；
3. 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；
4. HBsAg positive,or HBcAb positive and HBV-DNA positive；
5. Received CYC within 3 months before the first administration or Received rituximab(RTX) within 12 months before the first administration；
6. Received glucocorticoid shock therapy within 4 weeks before the first administration；
7. Received an oral daily dose of a GC of \> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration；
8. Received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration；
9. Received Continuous dialysis treatment for 12 weeks or more before the first administration; Received Dialysis within 1 week before the first administration;
10. Received intravenous immunoglobulin (Ig) or plasma exchange within 4 weeks before the first administration;
11. Pregnant or lactating.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minghui Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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