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

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ClinicalTrials.gov Identifier: NCT03330418
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
RemeGen

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

Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Spectrum Disorders Biological: Placebo Biological: RC18 160 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders.
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: Placebo Comparator
Participants received placebo weekly administered subcutaneously for 48 times in the double-blind treatment period.Once the participants relapse,they should advance to the open phase.All participants were treated with the test drugs.
Biological: Placebo
Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.

Experimental: RC18 160 mg
Patients received the test group RC18 160mg weekly administered subcutaneously for 48 times.Starting with the forty-ninth dose,the trial went into the open phase . All participants were treated with the test drugs.
Biological: RC18 160 mg
In the Phase B,the researchers can adjust the dose of RC18 according to the subjects' willingness and recurrence, but the maximum dose of single dose should not exceed 320g.




Primary Outcome Measures :
  1. Time to first relapse after randomization [ Time Frame: 144 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144 [ Time Frame: 144 weeks ]
    The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.

  2. Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144 [ Time Frame: week 4,8,12,24,36,48,60,72,96,120,144 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330418


Contacts
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Contact: Binghua Xiao 86-010-58076833 xiaosir522@163.com

Locations
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China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China
Contact: Xianhao Xu    010-65282171    bjyyxcc@bjhmoh.cn   
Sponsors and Collaborators
RemeGen
Investigators
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Principal Investigator: xianhao Xu Beijing Hospital

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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT03330418     History of Changes
Other Study ID Numbers: C009NMOSDCLLI
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Neuromyelitis Optica
Pathologic Processes
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases