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RECRUITINGPHASE3

BDB-001 Phase III Trial in ANCA-Associated Vasculitis

A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis

NCT07168161•Staidson (Beijing) Biopharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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;
+1 more criteria

Locations (50)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Peking University International Hospital

Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

November 10, 2025

Primary Completion Date

April 16, 2027

Completion Date

February 29, 2028

Last Updated

November 25, 2025

Enrollment

300

ESTIMATED participants

Conditions

ANCA Associated Vasculitis (AAV)

Interventions

BDB-001 injection

DRUG

Cyclophosphamide

DRUG

Rituximab

BIOLOGICAL

Azathioprine

DRUG

Prednisone

DRUG

Contacts

Aiping Sun

CONTACT

+86 010-67519614 sunaiping@staidson.com

Sponsors

Lead Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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