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RECRUITINGPHASE2/PHASE3

A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

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

NCT06413654•Shanghai Jiaolian Drug Research and Development Co., Ltd

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+9 more criteria

Locations (51)

Beijing Anzhen Hospital，Capital Medical University

Beijing, China

Beijing Tiantan Hospital，Capital Medical University

Beijing, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Peking University First Hospital

Beijing, China

The First Medical Center of PLA General Hospital

Beijing, China

The Third Medical Center of PLA General Hospital

Beijing, China

Cangzhou Central Hospital

Cangzhou, China

The Second Xiangya Hospital of Central South University

Changsha, China

Xiangya Hospital Central South University

Changsha, China

Sichuan Provincial People's Hospital

Chengdu, China

Key Dates

Start Date

July 17, 2024

Primary Completion Date

October 31, 2027

Completion Date

February 28, 2029

Last Updated

January 27, 2025

Enrollment

132

ESTIMATED participants

Conditions

Neuromyelitis Optica Spectrum Disorders

Interventions

B001

DRUG

Placebo

OTHER

Contacts

FuDong Shi

CONTACT

0086-010-59978555 ttyyirb@163.com

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

NCT06620809

Neuromyelitis Optica Spectrum Disorders

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RECRUITING

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

NCT07202494

Multiple SclerosisNeuromyelitis Optica Spectrum Disorders+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

Inclusion Criteria

Exclusion Criteria

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)

Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.

An Open Label Study of the Effects of SHR1459 in NMOSDs Patients

The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)