Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder
Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-05-05
132
Participants Needed
51
Research Sites
69 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
Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups: one receiving B001 injections and the other receiving placebo injections matching B001's schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.
CONDITIONS
Brief 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 the past year or at least 2 relapses within the past 2 years prior to screening
- Negative blood pregnancy test within 7 days before first dose for fertile females
- Willing to use reliable contraception during the study and for 6 months after stopping the study drug if fertile
- Voluntary participation with signed informed consent and ability to complete all study procedures
You will not qualify if you...
- Severe NMOSD judged unfit for study participation
- Chronic active immune diseases under systemic treatment
- Received anti-CD20 or other cell depletion therapy within 6 months before first dose
- Taken prescribed drug treatment shortly before first dose
- Participation in any drug clinical trial within 28 days before first dose
- Previous hematopoietic stem cell transplantation or lymphatic irradiation before first dose
- Pregnant or breastfeeding women or planning pregnancy during the trial
- Major surgery within 2 months before screening or planned during the trial
- Severe, progressive, or uncontrolled diseases increasing study risk
- 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 history of severe liver disease
- Uncontrolled systemic disease or other investigator concerns
- Abnormal laboratory test results
- History of alcohol or drug abuse within 6 months before screening
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 48 weeks
Participants receive intravenous doses of B001 or placebo on Day 1 and Day 15 during the randomized controlled period.
2 visits (in-person) on Day 1 and Day 15 of the treatment period
Trial Site Locations
Total: 51 locations
1
Beijing Anzhen Hospital，Capital Medical University
Beijing, China
Actively Recruiting
2
Beijing Tiantan Hospital，Capital Medical University
Beijing, China
Actively Recruiting
3
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Actively Recruiting
4
Peking University First Hospital
Beijing, China
Actively Recruiting
5
The First Medical Center of PLA General Hospital
Beijing, China
Actively Recruiting
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
Actively Recruiting
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
Actively Recruiting
19
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
Actively Recruiting
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
Actively Recruiting
28
Jiangxi Provincial People's Hospital
Nanchang, China
Actively Recruiting
29
Nanyang Central Hospital
Nanyang, China
Actively Recruiting
30
Qilu Hospital of Shandong University (Qingdao)
Qingdao, China
Actively Recruiting
31
The First Hospital of China Medical University
Shenyang, China
Actively Recruiting
32
Shenzhen Hospital of University of Hong Kong
Shenzhen, China
Actively Recruiting
33
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Actively Recruiting
34
Taihe Hospital
Shiyan, China
Actively Recruiting
35
First Hospital of Shanxi Medical University
Taiyuan, China
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36
Shanxi Provincial People's Hospital
Taiyuan, China
Actively Recruiting
37
Tianjin Medical University General Hospital
Tianjin, China
Actively Recruiting
38
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
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
Actively Recruiting
46
Yantai Mountain Hospital in Yantai City
Yantai, China
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47
The Central Hospital of Yongzhou
Yongzhou, China
Actively Recruiting
48
Zaozhuang Municipal Hospital
Zaozhuang, China
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49
Henan Provincial People's Hospital
Zhengzhou, China
Actively Recruiting
50
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
51
Zigong First People's Hospital
Zigong, China
Actively Recruiting
Research Team
F
FuDong Shi
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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