Actively Recruiting
A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-05-05
132
Participants Needed
51
Research Sites
241 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead Sponsor
S
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
CONDITIONS
Official Title
A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD)
- Experienced at least 1 NMOSD relapse within 1 year or at least 2 relapses within 2 years before screening
- Negative blood pregnancy test within 7 days before first dose for fertile females
- Agree to use reliable contraception during the study and for 6 months after stopping the study drug if fertile or if partner is fertile
- Willing to participate, understand the study, sign informed consent, and complete all study procedures
You will not qualify if you...
- Severe NMOSD judged by researcher as unsuitable for participation
- Chronic active immune system diseases under systemic treatment
- Anti-CD20 or other cell depletion therapy within 6 months before first dose
- Received prescribed drug treatments before first dose as specified
- Participation in any drug clinical trial within 28 days before first dose
- Hematopoietic stem cell transplantation or lymphatic irradiation before first dose
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Major surgery within 2 months prior to screening or planned during the trial
- Severe, progressive, or uncontrolled diseases increasing risk for study participation
- History of gastrointestinal perforation or fistula within 6 months before screening
- Live or attenuated vaccine within 4 weeks before first dose or planned vaccination during study
- Severe or persistent infection currently or within 1 month before screening
- Positive gamma interferon release test
- Active hepatitis or severe liver disease history
- Uncontrolled systemic disease or other investigator concerns
- Abnormal lab test results
- History of alcohol or drug abuse within 6 months before screening or ongoing abuse
- Severe mental illness with clinical uncooperativeness
- Unable to undergo magnetic resonance imaging or other investigator concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
Beijing Anzhen Hospital，Capital Medical University
Beijing, China
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2
Beijing Tiantan Hospital，Capital Medical University
Beijing, China
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3
Beijing Tongren Hospital, Capital Medical University
Beijing, China
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4
Peking University First Hospital
Beijing, China
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5
The First Medical Center of PLA General Hospital
Beijing, China
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6
The Third Medical Center of PLA General Hospital
Beijing, China
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7
Cangzhou Central Hospital
Cangzhou, China
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8
The Second Xiangya Hospital of Central South University
Changsha, China
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9
Xiangya Hospital Central South University
Changsha, China
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10
Sichuan Provincial People's Hospital
Chengdu, China
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11
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
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12
Guangzhou First People's Hospital
Guangzhou, China
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13
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
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14
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
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15
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
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16
Zhujiang Hospital of Southern Medical University
Guangzhou, China
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17
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
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18
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
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19
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
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20
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
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21
Anhui Provincial Hospital
Hefei, China
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22
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
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23
Huizhou First Hospital
Huizhou, China
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24
The First Affiliated Hospital of Shandong First Medical University
Jinan, China
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25
Affiliated Hospital of Jining Medical University
Jining, China
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26
First Affiliated Hospital of Kunming Medical University
Kunming, China
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27
First People's Hospital of Yunnan Province
Kunming, China
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28
Jiangxi Provincial People's Hospital
Nanchang, China
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29
Nanyang Central Hospital
Nanyang, China
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30
Qilu Hospital of Shandong University (Qingdao)
Qingdao, China
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31
The First Hospital of China Medical University
Shenyang, China
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32
Shenzhen Hospital of University of Hong Kong
Shenzhen, China
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33
The Second Hospital of Hebei Medical University
Shijiazhuang, China
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34
Taihe Hospital
Shiyan, China
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35
First Hospital of Shanxi Medical University
Taiyuan, China
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36
Shanxi Provincial People's Hospital
Taiyuan, China
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37
Tianjin Medical University General Hospital
Tianjin, China
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38
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
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39
Renmin Hospital of Wuhan University
Wuhan, China
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40
Tongji Hospital
Wuhan, China
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41
The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
Xi'an, China
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42
Xi'an International Medical Center Hospital
Xi'an, China
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43
The First Affiliated Hospital of Xiamen University
Xiamen, China
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44
Zhongshan Hospital Xiamen University
Xiamen, China
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45
Yan'an University Xianyang Hospital
Xianyang, China
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46
Yantai Mountain Hospital in Yantai City
Yantai, China
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47
The Central Hospital of Yongzhou
Yongzhou, China
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48
Zaozhuang Municipal Hospital
Zaozhuang, China
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49
Henan Provincial People's Hospital
Zhengzhou, China
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50
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
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51
Zigong First People's Hospital
Zigong, China
Actively Recruiting
Research Team
F
FuDong Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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