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Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)

NCT05145361•Shanghai Pharmaceuticals Holding Co., Ltd

View on ClinicalTrials.gov

Summary

The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening
•2. Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
•3. Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
•4. Age 18 to 70 years, inclusive at the time of informed consent

Exclusion Criteria

•1. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.
•2. Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.
•3. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
•4. Known active infection within 3 months prior to baseline
•5. Pregnancy or lactation.
•6. History of severe allergic reaction to a biologic agent
•7. Evidence of chronic active hepatitis B or C
•8. Evidence of active tuberculosis
•9. Following laboratory abnormalities at screening\*:
•1. White blood cells (WBC) \<4.0 x10\^3/microliter (μL)
+7 more criteria

Locations (4)

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Tangdu hospital,fourth military medical university

Xi’an, Shanxi, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

April 7, 2022

Primary Completion Date

December 15, 2025

Completion Date

December 15, 2025

Last Updated

August 17, 2025

Enrollment

ESTIMATED participants

Conditions

NMO Spectrum Disorder

Interventions

B001 injection

DRUG

Placebo

BIOLOGICAL

Contacts

Fu-Dong Shi, MD,PhD

CONTACT

022-60814587 Shifudong219@163.com

Biorepository and Registry for Plasma Exchange Patients

NCT05004493

Antibody-mediated RejectionNMO Spectrum Disorder+2 more

View study

COMPLETEDPHASE3

Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

NCT02028884

Neuromyelitis Optica (NMO)NMO Spectrum Disorder (NMOSD)

View study

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: August 17, 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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Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

Inclusion Criteria

Exclusion Criteria

Biorepository and Registry for Plasma Exchange Patients

Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Imaging Evaluation of Central Nervous Autoimmune Diseases