Injection of RC18 for treating Neuromyelitis Optica Spectrum Disorders
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.
This study is testing if an injection of RC18 can help people with Neuromyelitis Optica Spectrum Disorders feel better and have fewer relapses.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | RemeGen Co., Ltd. Industry-sponsored |
| Drugs / interventions | rituximab, Tocilizumab, Methotrexate, Cyclophosphamide |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT03330418 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of RC18, a TACI-antibody fusion protein, in patients diagnosed with Neuromyelitis Optica Spectrum Disorders. Participants will receive either the RC18 injection or a placebo to determine the treatment's impact on their condition. The study aims to enroll individuals who meet specific diagnostic criteria and have experienced multiple relapses of the disorder. The primary focus is to assess how well RC18 can manage symptoms and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Neuromyelitis Optica Spectrum Disorders who have experienced at least two relapses in the past two years and are AQP4 antibody positive.
Not a fit: Patients with other serious medical conditions, recent treatment with certain monoclonal antibodies, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of Neuromyelitis Optica Spectrum Disorders and reduce relapse rates.
How similar studies have performed: While this approach is novel, similar studies targeting Neuromyelitis Optica Spectrum Disorders have shown promise in exploring new treatment options.
Eligibility criteria
Show full 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.
Where this trial is running
Beijing, Beijing
- Beijing Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: xianhao Xu — Beijing Hospital
- Study coordinator: Binghua Xiao
- Email: xiaosir522@163.com
- Phone: 86-010-58076833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.