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RecruitingPhase 3NCT07168161

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

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Enrollment

300 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

ANCA Associated Vasculitis (AAV)

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Azathioprine, a drug called BDB-001 injection, and others for people with anca associated vasculitis (aav). The study is currently recruiting participants at 60 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBDB-001 injection

Intravenously administered

DRUGCyclophosphamide

Intravenously administered

BIOLOGICALRituximab

Intravenously administered

DRUGAzathioprine

Intravenously administered

DRUGPrednisone

Intravenously administered

Locations(60)

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 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

Guangdong General Hospital

Guangzhou, Guangdong, China

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

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Yuebei People's Hospital

Shaoguan, Guangdong, China

Guangdong Provincial People's Hospital

Shenzhen, Guangdong, China

Peking university Shenzhen Hospital

Shenzhen, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi Zhuang Autonomous Region (gzar), China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Cangzhou City People's Hospital

Cangzhou, Hebei, China

The Second Hospital of Hebei Medical University City:Shijiazhuang

Shijiazhuang, Hebei, China

Kailuan General Hospital

Tangshan, Hebei, China

The Second Affiliated Hospital of Harbin

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital,Tongji Medical college of Hust

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

General Hospital of Hunan University of Medicine

Changde, Hunan, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Xiangya Hospital Central South University (Nephrology Department)

Changsha, Hunan, China

Xiangya Hospital Central South University(Rheumatism Immunity Branch)

Changsha, Hunan, China

General Hospital of Hunan University of Medicine

Huaihua, Hunan, China

Zhuzhou Central Hospital

Zhuzhou, Hunan, China

Nanjing Gulou Hospital

Nanjing, Jiangsu, China

Nanjing University School of Medicine Affiliated Gulou Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Affiliated Hospital of Yanbian University (Yanbian Hospital)

Yanbian, Jilin, China

Shengjing Hospital of China Medical University

Shengyang, Liaoning, China

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Neimenggu, China

Shandong Provincial Hospital

Jinan, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Zhongshan hospital,Fudan University

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Xijing Hospital

Xi’an, Shanxi, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

People's Hospital of Lishui

Lishui, Zhejiang, China

The Affiliated Hospital of the Medical School of Ningbo University

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT07168161

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