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Recruiting NCT06413654

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

Phase II / Phase III Interventional Neuromyelitis Optica Spectrum Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: B001, Placebo.
Who it may be relevant to
Registry conditions: Neuromyelitis Optica Spectrum Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug B001
    The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP
  • Other Placebo
    The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP

Primary outcome measures

  • Time to first NMOSD Attack During RCP [Time frame: Approximately 48 weeks]
Secondary outcome measures (5)
  • Change in Expanded Disability Status Scale (EDSS) Score [Time frame: Approximately 48 weeks]
  • Change in Vision Acuity/ Low contrast visual acuity (VA/LCVA) [Time frame: Approximately 48 weeks]
  • Annualized relapse rate (ARR) [Time frame: Approximately 3 years]
  • Change in Opticospinal Impairment Scale (OSIS) [Time frame: Approximately 48 weeks]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Approximately 3 years]

Eligibility criteria

Inclusion criteria

  • Confirmed NMOSD patients;
  • Experienced at least 1 recurrence of NMOSD within 1 year or at least 2 recurrence within 2 years prior to screening;
  • 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;
  • 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

  • Subjects with severe NMOSD were judged by the researcher to be unfit to participate in this study;
  • Subjects with chronic active immune system diseases undergoing systematic treatment;
  • Received anti-CD20 or other cell depletion therapy within 6 months before first dose;
  • Received the prescribed drug treatment at the prescribed time before first dose;
  • Subjects who have participated in any drug clinical trials within 28 days prior to the first dose;
  • Received hematopoietic stem cell transplantation、 lymphatic irradiation before first dose;
  • Pregnant or lactating women; Subjects with birth plans during the trial;
  • Subjects who had undergone major surgery within 2 months prior to screening or were scheduled to undergo major surgery during the trial;
  • Subjects with severe, progressive, or uncontrolled disease who have been assessed by the investigator to be at increased risk of participating in the study;
  • A history of gastrointestinal perforation and/or fistula within 6 months prior to screening;
  • 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;
  • Subjects with severe or persistent infection currently or within the 1 months prior to screening;
  • Subjects with positive gamma interferon release test;
  • Subjects who currently have active hepatitis or have a history of severe liver disease;
  • Uncontrolled systemic disease, or any other reason the investigator deems inappropriate for inclusion;
  • Abnormal laboratory test results;
  • Subjects with a history of alcohol or drug abuse in the 6 months prior to screeing, or who are abusing;
  • Subjects with symptoms of severe mental illness who are clinically uncooperative;
  • Subjects who were unable to undergo magnetic resonance imaging during the study and who had other conditions that the investigator considered inappropriate to enroll.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 51 centers
  • Beijing Anzhen Hospital，Capital Medical University — Beijing
  • Beijing Tiantan Hospital，Capital Medical University — Beijing
  • Beijing Tongren Hospital, Capital Medical University — Beijing
  • Peking University First Hospital — Beijing
  • The First Medical Center of PLA General Hospital — Beijing
  • The Third Medical Center of PLA General Hospital — Beijing
  • Cangzhou Central Hospital — Cangzhou
  • The Second Xiangya Hospital of Central South University — Changsha
  • … and 43 more centers

Identifiers

NCT: NCT06413654 · SPH-B001-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗