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Treatment of Neuromyelitis Optica Spectrum Disorders with B001 Injection

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

Phase2; Phase3 Interventional Shanghai Jiaolian Drug Research and Development Co., Ltd · NCT06413654

This study is testing if a new injection called B001 can help people with neuromyelitis optica spectrum disorders who have had multiple flare-ups feel better and have fewer recurrences.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment132 (estimated)
Ages18 Years and up
SexAll
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd Industry-sponsored
Locations51 sites (Beijing and 50 other locations)
Trial IDNCT06413654 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of B001 injection in patients with neuromyelitis optica spectrum disorders (NMOSD) who are positive for aquaporin-4 antibodies. The study involves administering B001 or a placebo to participants who have experienced multiple recurrences of NMOSD. The trial aims to determine whether B001 can effectively reduce the frequency of these recurrences and improve patient outcomes. Participants will be closely monitored throughout the study to assess both the therapeutic effects and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with NMOSD who have had at least one recurrence in the past year or two recurrences in the past two years.

Not a fit: Patients with severe NMOSD deemed unfit for the study or those undergoing other systemic treatments for chronic immune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of NMOSD recurrences and improve the quality of life for affected patients.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies targeting NMOSD have shown promise, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Beijing and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neuromyelitis Optica Spectrum Disorders
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.