A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
NCT ID: NCT06413654
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
132 participants
INTERVENTIONAL
2024-07-17
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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B001 injection
B001
The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP
Placebo
Placebo
The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP
Interventions
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B001
The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP
Placebo
The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP
Eligibility Criteria
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Inclusion Criteria
2. Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
3. The blood pregnancy tests were negative within 7 days before the first dose in fertile female subjects. The fertile subjects and the male subjects whose partner are fertile woman agree to use reliable contraception during the study period and within 6 months after the study drug discontinuation;
4. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Willing to follow and able to complete all test procedures.
Exclusion Criteria
2. Subjects with chronic active immune system diseases undergoing systematic treatment;
3. Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
4. Received the prescribed drug treatment at the prescribed time before first dose;
5. Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;
6. Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
7. Pregnant or lactating women; Subjects with birth plans during the trial;
8. Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;
9. Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;
10. A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;
11. Subjects who received a live or attenuated vaccine within 4 weeks prior to initial administration, or who plan to receive vaccination during the study period;
12. Subjects with severe or persistent infection currently or within the 1 months prior to screening;
13. Subjects with positive gamma interferon release test;
14. Subjects who currently have active hepatitis or have a history of severe liver disease;
15. Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;
16. Abnormal laboratory test results;
17. Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;
18. Subjects with symptoms of severe mental illness who are clinically uncooperative;
19. Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.
18 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Shanghai Jiaolian Drug Research and Development Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Anzhen Hospital，Capital Medical University
Beijing, , China
Beijing Tiantan Hospital，Capital Medical University
Beijing, , China
Beijing Tongren Hospital, Capital Medical University
Beijing, , China
Peking University First Hospital
Beijing, , China
The First Medical Center of PLA General Hospital
Beijing, , China
The Third Medical Center of PLA General Hospital
Beijing, , China
Cangzhou Central Hospital
Cangzhou, , China
The Second Xiangya Hospital of Central South University
Changsha, , China
Xiangya Hospital Central South University
Changsha, , China
Sichuan Provincial People's Hospital
Chengdu, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
Guangzhou First People's Hospital
Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
Zhujiang Hospital of Southern Medical University
Guangzhou, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, , China
The Second Affiliated Hospital of Harbin Medical University
Harbin, , China
Anhui Provincial Hospital
Hefei, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Huizhou First Hospital
Huizhou, , China
The First Affiliated Hospital of Shandong First Medical University
Jinan, , China
Affiliated Hospital of Jining Medical University
Jining, , China
First Affiliated Hospital of Kunming Medical University
Kunming, , China
First People's Hospital of Yunnan Province
Kunming, , China
Jiangxi Provincial People's Hospital
Nanchang, , China
Nanyang Central Hospital
Nanyang, , China
Qilu Hospital of Shandong University (Qingdao)
Qingdao, , China
The First Hospital of China Medical University
Shenyang, , China
Shenzhen Hospital of University of Hong Kong
Shenzhen, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
Taihe Hospital
Shiyan, , China
First Hospital of Shanxi Medical University
Taiyuan, , China
Shanxi Provincial People's Hospital
Taiyuan, , China
Tianjin Medical University General Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Tongji Hospital
Wuhan, , China
The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
Xi'an, , China
Xi'an International Medical Center Hospital
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Zhongshan Hospital Xiamen University
Xiamen, , China
Yan'an University Xianyang Hospital
Xianyang, , China
Yantai Mountain Hospital in Yantai City
Yantai, , China
The Central Hospital of Yongzhou
Yongzhou, , China
Zaozhuang Municipal Hospital
Zaozhuang, , China
Henan Provincial People's Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Zigong First People's Hospital
Zigong, , China
Countries
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Central Contacts
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Facility Contacts
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Guangzhi Liu
Role: primary
Fudong Shi
Role: primary
Libin Jiang
Role: primary
Feng Gao
Role: primary
Huanfen Zhou
Role: primary
Quangang Xu
Role: primary
Jieqiong Liu
Role: primary
Xiaomei Wu
Role: primary
Kai Hu
Role: primary
Fei Xu
Role: primary
Aiyu Lin
Role: primary
Honghao Wang
Role: primary
Yamei Tang
Role: primary
Jinsheng Zeng
Role: primary
Wei Qiu
Role: primary
Qing Wang
Role: primary
Lan Chu
Role: primary
Zhiying Wu
Role: primary
Zhuobo Zhang
Role: primary
Lihua Wang
Role: primary
Zhaozhao Cheng
Role: primary
Yanghua Tian
Role: primary
Qianwu Zhou
Role: primary
Ruisheng Duan
Role: primary
Yuzhong Wang
Role: primary
Yanbing Han
Role: primary
Qiang Meng
Role: primary
Wenfeng Cao
Role: primary
Changming Wen
Role: primary
Yun Wang
Role: primary
Zhe Wu
Role: primary
Haibing Xiao
Role: primary
Bin Li
Role: primary
Jinquan Hu
Role: primary
Meini Zhang
Role: primary
Hongen Wei
Role: primary
Li Yang
Role: primary
Xu Zhang
Role: primary
Ting Chen
Role: primary
Daishi Tian
Role: primary
Jun Guo
Role: primary
Hong Lin
Role: primary
Qilin Feng
Role: primary
Xingyu Chen
Role: primary
Xiongfei Zhao
Role: primary
Jianhua Tang
Role: primary
Sufang Wu
Role: primary
Feng Wang
Role: primary
Yue Huang
Role: primary
Yuming Xu
Role: primary
Tao Qiu
Role: primary
Other Identifiers
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SPH-B001-301
Identifier Type: -
Identifier Source: org_study_id
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