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

April 29, 2026 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital Capital Medical University
        • Contact:
        • Principal Investigator:
          • Xinghu Zhang
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
        • Principal Investigator:
          • Meini Zhang
      • Xi’an, Shanxi, China, 710038
        • Recruiting
        • Tangdu hospital,fourth military medical university
        • Contact:
        • Principal Investigator:
          • Jun Guo
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
        • Principal Investigator:
          • Fu-Dong Shi, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)
    2. Absolute neutrophil count (ANC)
    3. Absolute lymphocyte count <0.5 x10^3/μL
    4. Platelet count <80 x 10^9/ L
    5. Aspartate aminotransferase (AST) or alanine aminotransferase
  10. History of drug or alcohol abuse within 6 months prior to baseline
  11. Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
  12. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: B001 injection
Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study.
Drug: B001 injection
B001 injection 50mg/5mL Intravenous solution
Placebo Comparator: Placebo
Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study.
Biological: Placebo
Placebo 5mL Intravenous solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: Up to 18 days.
Measurement of DLT in all subjects.
Up to 18 days.
Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].
Time Frame: Up to 1 year
Up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum serum concentration (Cmax) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Time of maximum serum concentration (Tmax) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Terminal rate constant(λz) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Half-life (t1/2) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Total clearance(CL) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Volume of distribution(Vz) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Percentage of area under the serum concentration-time curve (AUC 0-infinity) obtained by extrapolation (%AUCex) of B001.
Time Frame: Through study completion, up to 2 years
To characterize the PK (Pharmacokinetics) of B001.
Through study completion, up to 2 years
Percentage of subjects with ADA to B001 and neutralizing resistance (Nab)
Time Frame: Through study completion, up to 2 years
Through study completion, up to 2 years
Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period
Time Frame: Through study completion, up to 2 years
Through study completion, up to 2 years
Change in Expanded Disability Status Scale (EDSS) Score
Time Frame: Through study completion, up to 2 years
The EDSS provides a total score on a scale that ranges from 0 to 10 in 0.5 increments that represent higher levels of disability. Increasing disability is reflected in an increasing EDSS score.
Through study completion, up to 2 years
Time to EDSS Worsening
Time Frame: Through study completion, up to 2 years
Through study completion, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fu-Dong Shi, MD,PhD, Tianjin Medical University General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B001-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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