A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders

Summary

This is a phase II/III multicenter, randomized, double-blind, placebo-controlled study, to investigate the efficacy and safety of BAT4406F injection in patients with neuromyelitis optica lineage disease (NMOSD) who are positive for aquaporin 4 antibody (AQP4-IgG) .

Conditions

• Optic Neuromyelitis Spectrum Disease

Interventions

DRUG

BAT4406F Injection

Intravenous infusion; Dosage:500mg/time

DRUG

BAT4406F Placebos

Intravenous infusion; Dosage:500mg/time

Sponsors & Collaborators

• Bio-Thera Solutions

  lead INDUSTRY

Principal Investigators

• Xiangjun Chen, Doctor · Huashan Hospital

• Chunfeng Liu, Doctor · Second Affiliated Hospital of Suzhou University

• Qun Xue, Doctor · First Affiliated Hospital of Suzhou University

• Yan Jiang, Doctor · Anhui Provincial Hospital

• Yuying Zhao, Doctor · Shandong University Qilu Hospital

• Li Guo, Doctor · Second Hebei Medical University Hospital

• Meini Zhang, Doctor · The First Affiliated Hospital of Shanxi Medical University

• Huan Yang, Doctor · The Central South University Xiang Ya Hospital

• Daishi Tian, Doctor · Tongji hospital affiliated to Tongji Medical College

• Yuming Xu, Doctor · The First Affiliated Hospital of Zhengzhou University

• Jianglong Tu, Doctor · Second Affiliated Hospital of Nanchang University

• Wei Qiu, Doctor · The third hospital affiliated to sun yat-sen university

• Yamei Tang, Doctor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Honghao Wang, Doctor · The First People's Hospital of Guangzhou

• Xiaoling Luo, Doctor · Shenzhen city people's hospital

• Aiyu Lin, Doctor · First Affiliated Hospital of Fujian Medical University

• Chunming Xie, Doctor · China University Hospital of Southeast University

• Xiang Li, Doctor · The first hospital affiliated to wenzhou medical college

• Lan Tan, Doctor · Qingdao City Hospital

• Fudong Shi, Doctor · Tianjin Medical University General Hospital

• Juming Yu, Doctor · Affiliated Hospital of North Sichuan Medical College

• Jun Guo, Doctor · The Second Affiliated Hospital of the PLA Air Force Military Medical University

• Jiewen Zhang, Doctor · Henan Provincial People's Hospital

• Yanghua Tian, Doctor · Second Affiliated Hospital of Anhui Medical University

• Jing Ding, Doctor · Shanghai Zhongshan Hospital

• Ping Chen, Doctor · Xianyang yanan university hospital co., LTD

• Zunbo Li, Doctor · Xi'an high-tech Hospital Co. , Ltd.

• Qihe Dai, Doctor · Jingzhou city central hospital

• Dan Liu, Doctor · the first hospital of Baotou medicine college

• Junyan Liu, Doctor · Hebei Medical University Third Hospital

• Yiqi Wang, Doctor · Zhejiang Province People's Hospital

• Bo Hu, Doctor · Xiehe hospital affiliated to tongji medical college

• Yanbing Han, Doctor · First Affiliated Hospital of the Kunming Medical University

• Feng Wang, Doctor · Wuxi city people's hospital

• Zhanhua Liang, Doctor · The First Affiliated Hospital of Dalian Medical University

• Weihe Zhang, Doctor · Sino-Japanese Friendship Hospital

• Xiangyang Zhu, Doctor · Nantong First People's Hospital

• Xinfeng Liu, Doctor · The Chinese people's liberation army general hospital in eastern theater

• Weidong Pan, Doctor · Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

• Wei Lu, Doctor · The Central South University Xiang YA II hospital

• Huiyu Feng, Doctor · The first hospital affiliated to sun yat-sen university

• Feng Gao, Doctor · The first hospital of Peking University

• Yun Xu, Doctor · Drum tower hospital affiliated to nanjing university school of medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• China

Study Locations