NCT07168161

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• ANCA Associated Vasculitis (AAV)

Interventions

Type	Name	Description
DRUG	BDB-001 injection	Intravenously administered
DRUG	Cyclophosphamide	Intravenously administered
BIOLOGICAL	Rituximab	Intravenously administered
DRUG	Azathioprine	Intravenously administered
DRUG	Prednisone	Intravenously administered

Timeline

• Start date: 2025-11-10
• Primary completion: 2027-04-16
• Completion: 2028-02-29
• First posted: 2025-09-11
• Last updated: 2025-11-25

Locations

50 sites across 1 country: China