Clinical trial NCT03330418: A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neuromyelitis Optica Spectrum Disorders
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Time to first relapse after randomization
timeFrame: 144 weeks
Secondary outcomes:
measure: Change from Baseline in Expanded Disability Status Scale (EDSS) Score at week 4,8,12,24,36,48,60,72,96,120,144
timeFrame: 144 weeks
measure: Change from Baseline in Hauser Ambulation Index at week 4,8,12,24,36,48,60,72,96,120,144
timeFrame: week 4,8,12,24,36,48,60,72,96,120,144
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: xianhao Xu
role: PRINCIPAL_INVESTIGATOR
References: