A Phase II/III Study to Evaluate the Efficacy and Safety of BAT4406F Injection in Patients with Neuromyelitis Optica Lineage Disease

Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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) .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age greater than or equal to the age of 18 and less than or equal to 65 patients, gender not limited;

• Met the 2015 international NMO diagnostic panel (IPND) criteria for NMOSD, And AQP4-IGG positive patients

• Screening before 2 times at least 2 years experience with clinical records of relapse,or experienced at least 1 clinically documented recurrence within 1 year prior to screening

• For subjects who had a relapse before screening, symptoms needed to be stable for at least 4 weeks before randomization

• Into the group of former dosage of corticosteroids under 30 mg and prednisone equivalent,and the trial drug must be used within a month after the withdrawal of hormones

• The score of EDSS 7 or less

• Has the fertility of men and women must agree during treatment and 6 months after the last dose of using effective birth control method;

• Agreed to participate in trials, and books to sign the informed consent

Locations
Other Locations
China
The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology
RECRUITING
Baotou
Beijing Hospital
NOT_YET_RECRUITING
Beijing
China-japan friendship Hospital
NOT_YET_RECRUITING
Beijing
The first hospital of Peking University
NOT_YET_RECRUITING
Beijing
The Central South University Xiang Ya Hospital
NOT_YET_RECRUITING
Changsha
Xiangya 2nd hospital of central south university
NOT_YET_RECRUITING
Changsha
First affiliated hospital of chongqing medical university
NOT_YET_RECRUITING
Chongqing
The first affiliated hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
First affiliated hospital of fujian medical university
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The first hospital affiliated to sun yat-sen university
NOT_YET_RECRUITING
Guangzhou
The first People's Hospital of Guangzhou
NOT_YET_RECRUITING
Guangzhou
The third hospital affiliated to sun yat-sen university
NOT_YET_RECRUITING
Guangzhou
People's Hospital of Zhejiang province
NOT_YET_RECRUITING
Hangzhou
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Second Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Shandong University Qilu Hospital
NOT_YET_RECRUITING
Jinan
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jingzhou
First Affiliated Hospital of the Kunming Medical University
NOT_YET_RECRUITING
Kunming
Second Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Affiliated Hospital of North Sichuan Medical College
NOT_YET_RECRUITING
Nanchong
Drum Tower Hospital affiliated to Medical College of Nanjing University
NOT_YET_RECRUITING
Nanjing
Southeast university affiliated zhongda hospital
NOT_YET_RECRUITING
Nanjing
The Chinese people's liberation army general hospital in eastern theater
NOT_YET_RECRUITING
Nanjing
The first People's Hospital of Nantong
NOT_YET_RECRUITING
Nantong
Qingdao municipal hospital
NOT_YET_RECRUITING
Qingdao
Mount Hua Hospital affiliated to Fudan University
RECRUITING
Shanghai
Shuguang hospital affiliated to Shanghai University of Traditional Chinese medicine
NOT_YET_RECRUITING
Shanghai
Zhongshan hospital affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Shenzhen city people's hospital
NOT_YET_RECRUITING
Shenzhen
Second Hebei Medical University Hospital
NOT_YET_RECRUITING
Shijia Zhuang
The Third Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
First Affiliated Hospital of Suzhou University
NOT_YET_RECRUITING
Suzhou
The Second Affiliated Hospital of Suzhou University
NOT_YET_RECRUITING
Suzhou
The first hospital of shanxi medical university
NOT_YET_RECRUITING
Taiyuan
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
The first hospital affiliated to wenzhou medical college
NOT_YET_RECRUITING
Wenzhou
Tongji hospital affiliated to tongji medical college huazhong university of science and technology
NOT_YET_RECRUITING
Wuhan
Xiehe hospital affiliated to tongji medical college huazhong university of science and technology
NOT_YET_RECRUITING
Wuhan
Wuxi city people's hospital
RECRUITING
Wuxi
Second Affiliated Hospital of the People's Liberation Army Air Force Military Medical University
NOT_YET_RECRUITING
Xi'an
Xi'an high-tech Hospital Co. , Ltd.
RECRUITING
Xi'an
Yan 'an University Xianyang Hospital Co. , Ltd.
RECRUITING
Xianyang
Henan province people's hospital
NOT_YET_RECRUITING
Zhengzhou
Zhengzhou university first affiliated hospital
NOT_YET_RECRUITING
Zhenzhou
Contact Information
Primary
Weining Li, Master
wnli@bio-thera.com
15202417078
Backup
Zhaohe Wang, Doctor
zhwang@bio-thera.com
86-20-32203220
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 162
Treatments
Experimental: Experimental group:BAT4406F
RCP:Intravenous infusion; Dosage:500mg/time; Time of administration:The drug was given at D 1 and D 182 respectively OLP:Intravenous infusion; Dosage:500mg/time; Time of administration: After D1 dosing, Every 6 months to 1 times
Active_comparator: Control group:BAT4406F Placebos
RCP:Intravenous infusion; Dosage:500mg/time; Time of administration:The drug was given at D 1 and D 182 respectively OLP:Intravenous infusion; Dosage:500mg/time; Time of administration: After D1 dosing, Every 6 months to 1 times
Sponsors
Leads: Bio-Thera Solutions

This content was sourced from clinicaltrials.gov

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