BDB-001 Phase III Trial in ANCA-Associated Vasculitis

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

September 29, 2025

Primary Completion Date

April 16, 2027

Study Completion Date

February 29, 2028

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

Trial Locations (50)

100005

Peking Union Medical College Hospital, Beijing

Tongji Hospital,Tongji Medical college of Hust, Wuhan

100044

Peking University People's Hospital, Beijing

100191

Peking University Third Hospital, Beijing

102206

Peking University International Hospital, Beijing

102218

Beijing Tsinghua Changgung Hospital, Beijing

110004

Shengjing Hospital of China Medical University, Shengyang

130041

The Second Hospital of Jilin University, Changchun

133000

Affiliated Hospital of Yanbian University (Yanbian Hospital), Yanbian

150086

The Second Affiliated Hospital of Harbin, Harbin

200025

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

200032

Zhongshan hospital,Fudan University, Shanghai

210000

Nanjing Gulou Hospital, Nanjing

Nanjing University School of Medicine Affiliated Gulou Hospital, Nanjing

250021

Shandong Provincial Hospital, Jinan

261041

Weifang People's Hospital, Weifang

310003

The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou

310009

The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

310014

Zhejiang Provincial People's Hospital, Hangzhou

330006

Jiangxi Provincial People's Hospital, Nanchang

The First Affiliated Hospital of Nanchang University, Nanchang

361003

The First Affiliated Hospital of Xiamen University, Xiamen

400010

The Second Affiliated Hospital of Chongqing Medical University, Chongqing

410005

Hunan Provincial People's Hospital, Changsha

410008

Xiangya Hospital Central South University (Nephrology Department), Changsha

Xiangya Hospital Central South University(Rheumatism Immunity Branch), Changsha

412007

Zhuzhou Central Hospital, Zhuzhou

415000

General Hospital of Hunan University of Medicine, Changde

418000

General Hospital of Hunan University of Medicine, Huaihua

443003

Yichang Central People's Hospital, Yichang

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

471003

The First Affiliated Hospital of Henan University of science and Technology, Luoyang

510080

Guangdong Provincial People's Hospital, Shenzhen

510120

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

518036

Peking university Shenzhen Hospital, Shenzhen

530016

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

530021

The First Affiliated Hospital of Guangxi Medical University, Nanning

545006

Liuzhou People's Hospital, Liuzhou

550002

Guizhou Provincial People's Hospital, Guiyang

610041

West China Hospital of Sichuan University, Chengdu

610072

Sichuan Provincial People's Hospital, Chengdu

710000

Peking University First Hospital, Beijing

710032

Xijing Hospital, Xi’an

710061

The First Affiliated Hospital of Xi'an Jiao Tong University, Xi’an

730000

The First Hospital of Lanzhou University, Lanzhou

830054

The First Affiliated Hospital of Xinjiang Medical University, Ürümqi

050004

The Second Hospital of Hebei Medical University City:Shijiazhuang, Shijiazhuang

010050

Affiliated Hospital of Inner Mongolia Medical University, Hohhot

030032

Shanxi Bethune Hospital, Taiyuan

The Second Hospital of Shanxi Medical University, Taiyuan

All Listed Sponsors
lead

Staidson (Beijing) Biopharmaceuticals Co., Ltd

INDUSTRY