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

Last updated: November 24, 2023
Sponsor: RemeGen Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Sclerosis

Treatment

RC18 160 mg

Placebo

Clinical Study ID

NCT03330418
C009NMOSDCLLI
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet the 2015 international consensus diagnostic criteria for Neuromyelitis OpticaSpectrum 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 randomizationand/ or 1 relapse within the first one year of randomization
  • Consent to use effective contraception during the study period (women of childbearingage)
  • Voluntarily signed informed consent

Exclusion

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 monthsprior to randomization .
  • Any concomitant disease other than neuromyelitis optica(NMO)/ neuromyelitis opticaSpectrum 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 administrationand 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,andPatients discontinued more than 5 times the half-life of the drug before they couldget into the group .If the patients taking leflunomide and teriflunomide,they shouldneed to take colestyramine for elution.
  • Have participated in any clinical trial in the first 28 days of the initial screeningor 5 times half-life period of the study compound (taking shorter time ).
  • The patients have severe psychiatric symptoms and are not compatible with clinicalstudies
  • 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 HeartAssociation 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 Design

Total Participants: 166
Treatment Group(s): 2
Primary Treatment: RC18 160 mg
Phase: 3
Study Start date:
January 29, 2018
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Beijing Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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