Neuromyelitis Optica Spectrum DisordersPhase 2/3NCT06413654
A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
A Phase 2/3 study testing B001 in people with Neuromyelitis Optica Spectrum Disorders, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 51 sites in China.
Trial summary
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders
- What is being tested?
- B001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 51 sitesChina
- Study dates
- 17 Jul 2024to 28 Feb 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed NMOSD patients;
- Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
- 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;
- 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.
Who cannot join
- Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
- Subjects with chronic active immune system diseases undergoing systematic treatment;
- Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
- Received the prescribed drug treatment at the prescribed time before first dose;
- Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;
- Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
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- Pregnant or lactating women; Subjects with birth plans during the trial;
- Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;
- Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;
- A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;
- 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;
- Subjects with severe or persistent infection currently or within the 1 months prior to screening;
- Subjects with positive gamma interferon release test;
- Subjects who currently have active hepatitis or have a history of severe liver disease;
- Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;
- Abnormal laboratory test results;
- Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;
- Subjects with symptoms of severe mental illness who are clinically uncooperative;
- Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.
Trial locations and contacts
51 sites in 1 country. Contact the study team or a site near you to ask about taking part.
51 sites in 1 country
China51 sites, 51 recruiting
- Recruiting
Beijing Anzhen Hospital，Capital Medical University
Beijing
Guangzhi Liu
- Recruiting
Beijing Tiantan Hospital，Capital Medical University
Beijing
Fudong Shi
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing
Libin Jiang
- Recruiting
Peking University First Hospital
Beijing
Feng Gao
- Recruiting
The First Medical Center of PLA General Hospital
Beijing
Huanfen Zhou
- Recruiting
The Third Medical Center of PLA General Hospital
Beijing
Quangang Xu
- Recruiting
Cangzhou Central Hospital
Cangzhou
Jieqiong Liu
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha
Xiaomei Wu
- Recruiting
Xiangya Hospital Central South University
Changsha
Kai Hu
- Recruiting
Sichuan Provincial People's Hospital
Chengdu
Fei Xu
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Aiyu Lin
- Recruiting
Guangzhou First People's Hospital
Guangzhou
Honghao Wang
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Yamei Tang
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Jinsheng Zeng
- Recruiting
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou
Wei Qiu
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou
Qing Wang
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang
Lan Chu
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhiying Wu
- Recruiting
The Fourth Affiliated Hospital of Harbin Medical University
Harbin
Zhuobo Zhang
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin
Lihua Wang
- Recruiting
Anhui Provincial Hospital
Hefei
Zhaozhao Cheng
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei
Yanghua Tian
- Recruiting
Huizhou First Hospital
Huizhou
Qianwu Zhou
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan
Ruisheng Duan
- Recruiting
Affiliated Hospital of Jining Medical University
Jining
Yuzhong Wang
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming
Yanbing Han
- Recruiting
First People's Hospital of Yunnan Province
Kunming
Qiang Meng
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang
Wenfeng Cao
- Recruiting
Nanyang Central Hospital
Nanyang
Changming Wen
- Recruiting
Qilu Hospital of Shandong University (Qingdao)
Qingdao
Yun Wang
- Recruiting
The First Hospital of China Medical University
Shenyang
Zhe Wu
- Recruiting
Shenzhen Hospital of University of Hong Kong
Shenzhen
Haibing Xiao
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
Bin Li
- Recruiting
Taihe Hospital
Shiyan
Jinquan Hu
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan
Meini Zhang
- Recruiting
Shanxi Provincial People's Hospital
Taiyuan
Hongen Wei
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Li Yang
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Xu Zhang
- Recruiting
Renmin Hospital of Wuhan University
Wuhan
Ting Chen
- Recruiting
Tongji Hospital
Wuhan
Daishi Tian
- Recruiting
The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
Xi'an
Jun Guo
- Recruiting
Xi'an International Medical Center Hospital
Xi'an
Hong Lin
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Qilin Feng
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen
Xingyu Chen
- Recruiting
Yan'an University Xianyang Hospital
Xianyang
Xiongfei Zhao
- Recruiting
Yantai Mountain Hospital in Yantai City
Yantai
Jianhua Tang
- Recruiting
The Central Hospital of Yongzhou
Yongzhou
Sufang Wu
- Recruiting
Zaozhuang Municipal Hospital
Zaozhuang
Feng Wang
- Recruiting
Henan Provincial People's Hospital
Zhengzhou
Yue Huang
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Yuming Xu
- Recruiting
Zigong First People's Hospital
Zigong
Tao Qiu
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Being tested
- B001, Placebo
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B001Drug
The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP
PlaceboOther
The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP
| Study group | Role | What they receive |
|---|---|---|
| B001 injection | Experimental | Not described Receives: Drug: B001 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first NMOSD Attack During RCP
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD.
Measured: Approximately 48 weeks
Secondary outcomes (5)
Change in Expanded Disability Status Scale (EDSS) Score
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS).
Measured: Approximately 48 weeks
Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)
Change in VA/LCVA
Measured: Approximately 48 weeks
Annualized relapse rate (ARR)
Annualized attack rate is defined as total number of attacks divided by total person years.
Measured: Approximately 3 years
Change in Opticospinal Impairment Scale (OSIS)
Change in OSIS
Measured: Approximately 48 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start17 Jul 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413654
- Sponsor's protocol ID
- SPH-B001-301
- Status last verified
- Apr 2026
- First submitted
- 9 May 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06413654
- Acronym / sponsor ID
- SPH-B001-301
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B001 injection | Experimental | Drug: B001 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed NMOSD patients;
- Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
- 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;
- 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.
Key exclusion criteria (19 listed)
- Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
- Subjects with chronic active immune system diseases undergoing systematic treatment;
- Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
- Received the prescribed drug treatment at the prescribed time before first dose;
- Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B001The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP | Drug | B001 injection |
| PlaceboThe subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP | Other | Placebo |
Primary outcome
Time to first NMOSD Attack During RCP
Time frame: Approximately 48 weeks
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD.
5 secondary outcomes
Change in Expanded Disability Status Scale (EDSS) Score
Time frame: Approximately 48 weeks
Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA)
Time frame: Approximately 48 weeks
Annualized relapse rate (ARR)
Time frame: Approximately 3 years
Change in Opticospinal Impairment Scale (OSIS)
Time frame: Approximately 48 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing B001 in people with Neuromyelitis Optica Spectrum Disorders, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 51 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FuDong Shi (0086-010-59978555, ttyyirb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first NMOSD Attack During RCP (time frame: Approximately 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.