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A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders

A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders

Recruiting
18-65 years
All
Phase 3

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Overview

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.

Eligibility

Inclusion Criteria:

  • Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity.
  • EDSS 0-7.5
  • Clinical evidence of at least 2 relapses within the first two years of randomization and/ or 1 relapse within the first one year of randomization
  • Consent to use effective contraception during the study period (women of childbearing age)
  • Voluntarily signed informed consent

Exclusion Criteria:

  • Abnormal laboratory parameters need to be excluded, including but not limited to:
  • Currently suffering from active hepatitis or serious liver disease and medical history
  • Patients were treated with rituximab or other monoclonal antibodies within 6 months prior to randomization .
  • Any concomitant disease other than neuromyelitis optica(NMO)/ neuromyelitis optica Spectrum disorders(NMOSD)that required treatment with lucocorticoid.
  • pregnant , lactating women and men or women who have birth plans during the research;
  • Have a history of allergic reaction to contrast agent for parenteral administration and human biological medicines.
  • Receipt of intravenous immune globulin ( IVIG) within 28 days prior to randomization.
  • Receipt of any of the following prior to randomization: Azathioprine,Cyclosporin, Methotrexate Mitoxantrone,Cyclophosphamide,Tocilizumab,Tacrolimus,Mycophenolate,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .If the patients taking leflunomide and teriflunomide,they should need to take colestyramine for elution.
  • Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking shorter time ).
  • The patients have severe psychiatric symptoms and are not compatible with clinical studies
  • Malignant tumor patients ;
  • patients experienced any of the following events within 12 weeks before screening : myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association class IV heart failure
  • Patients can't accept magnetic resonance imaging inspection during the trial.
  • Infection with herpes zoster or HIV virus at the screening;
  • The anti-hepatitis C virus (anti-HCV) of patients show positive;
  • Investigator considers candidates not appropriating for the study.

Study details
    Neuromyelitis Optica Spectrum Disorders

NCT03330418

RemeGen Co., Ltd.

27 January 2024

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