# BDB-001 Phase III Trial in ANCA-Associated Vasculitis

> **NCT07168161** · PHASE3 · RECRUITING · sponsor: **Staidson (Beijing) Biopharmaceuticals Co., Ltd** · enrollment: 300 (estimated)

## Conditions studied

- ANCA Associated Vasculitis (AAV)

## Interventions

- **DRUG:** BDB-001 injection
- **DRUG:** Cyclophosphamide
- **BIOLOGICAL:** Rituximab
- **DRUG:** Azathioprine
- **DRUG:** Prednisone

## Key facts

- **NCT ID:** NCT07168161
- **Lead sponsor:** Staidson (Beijing) Biopharmaceuticals Co., Ltd
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-11-10
- **Primary completion:** 2027-04-16
- **Final completion:** 2028-02-29
- **Target enrollment:** 300 (ESTIMATED)
- **Last updated:** 2026-04-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07168161

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07168161, "BDB-001 Phase III Trial in ANCA-Associated Vasculitis". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT07168161. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*