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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT03330418
• Date of registration: 31/10/2017
• Prospective Registration: Yes
• Primary sponsor: RemeGen Co., Ltd.
• Public title: A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
• Scientific 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.
• Date of first enrolment: January 29, 2018
• Target sample size: 166
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03330418
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Xianhao Xu

• Name: Binghua Xiao

• Name: xianhao Xu
• Affiliation: Beijing Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neuromyelitis Optica Spectrum Disorders

Intervention(s)

Biological: RC18 160 mg

Biological: Placebo

Primary Outcome(s)

Time to first relapse after randomization [Time Frame: 144 weeks]

Secondary Outcome(s)

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]

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]

Secondary ID(s)

C009NMOSDCLLI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors