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BDB-001 Phase III Trial in ANCA-Associated Vasculitis

NCT07168161 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-23

No results posted yet for this study

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

DRUG

BDB-001 injection

Intravenously administered

DRUG

Cyclophosphamide

Intravenously administered

BIOLOGICAL

Rituximab

Intravenously administered

DRUG

Azathioprine

Intravenously administered

DRUG

Prednisone

Intravenously administered

Sponsors & Collaborators

  • Staidson (Beijing) Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Minghui Zhao, M.D. · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-10
Primary Completion
2027-04-16
Completion
2028-02-29

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168161 on ClinicalTrials.gov