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New shot aims to stop devastating NMOSD Flare-Ups

NCT ID NCT06413654

Disease control Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an injection called B001 in 132 people with a severe nerve disease called NMOSD. The goal is to see if it can prevent sudden attacks that cause vision loss, paralysis, or other serious symptoms. Participants will receive either B001 or a placebo, and researchers will track how long it takes for the next attack to occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Confirmed NMOSD patients; 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: 1. Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study; 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.

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Conditions

The condition(s) this trial relates to.

neuromyelitis optica

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuromyelitis optica spectrum disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    51 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, China

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, China

  • Beijing Anzhen Hospital，Capital Medical University

    RECRUITING

    Beijing, China

  • Beijing Tiantan Hospital，Capital Medical University

    RECRUITING

    Beijing, China

  • Beijing Tongren Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Cangzhou Central Hospital

    RECRUITING

    Cangzhou, China

  • First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, China

  • First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, China

  • First People's Hospital of Yunnan Province

    RECRUITING

    Kunming, China

  • Guangzhou First People's Hospital

    RECRUITING

    Guangzhou, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, China

  • Huizhou First Hospital

    RECRUITING

    Huizhou, China

  • Jiangxi Provincial People's Hospital

    RECRUITING

    Nanchang, China

  • Nanyang Central Hospital

    RECRUITING

    Nanyang, China

  • Peking University First Hospital

    RECRUITING

    Beijing, China

  • Qilu Hospital of Shandong University (Qingdao)

    RECRUITING

    Qingdao, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, China

  • Shanxi Provincial People's Hospital

    RECRUITING

    Taiyuan, China

  • Shenzhen Hospital of University of Hong Kong

    RECRUITING

    Shenzhen, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • Taihe Hospital

    RECRUITING

    Shiyan, China

  • The Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, China

  • The Central Hospital of Yongzhou

    RECRUITING

    Yongzhou, China

  • The First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, China

  • The First Affiliated Hospital of Shandong First Medical University

    RECRUITING

    Jinan, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, China

  • The First Medical Center of PLA General Hospital

    RECRUITING

    Beijing, China

  • The Fourth Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The Second Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University

    RECRUITING

    Xi'an, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, China

  • The Third Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • The Third Medical Center of PLA General Hospital

    RECRUITING

    Beijing, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, China

  • Tongji Hospital

    RECRUITING

    Wuhan, China

  • Xi'an International Medical Center Hospital

    RECRUITING

    Xi'an, China

  • Xiangya Hospital Central South University

    RECRUITING

    Changsha, China

  • Yan'an University Xianyang Hospital

    RECRUITING

    Xianyang, China

  • Yantai Mountain Hospital in Yantai City

    RECRUITING

    Yantai, China

  • Zaozhuang Municipal Hospital

    RECRUITING

    Zaozhuang, China

  • Zhongshan Hospital Xiamen University

    RECRUITING

    Xiamen, China

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, China

  • Zigong First People's Hospital

    RECRUITING

    Zigong, China

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