NCT05730699进行中（未招募）3 期
An Open-Label Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Biocad
- 入组人数
- 105
- 试验地点
- 19
- 主要终点
- Adjudicated annualized relapse rate [Week 24]
研究概览
简要总结
The goal of this clinical trial is to study the efficacy and safety of BCD-132 (divozilimab) in subjects with neuromyelitis optica spectrum disorders (NMOSD).
详细描述
BCD-132-6/AQUARELLE is an open-label phase 3 clinical study in subjects with NMOSD. Approximately 105 subjects will be enrolled.
The study consists of a screening period, a treatment period and a follow-up period. During treatment period, the subjects will receive the investigational product divozilimab.
The duration of participation for each subject will be approximately 104 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NMOSD diagnosed based on the 2015 NMOSD International Consensus Diagnostic Criteria
- •Documented evidence of at least 1 relapse within 12 months before signing the informed consent form, or 2 relapses within 24 months before signing the informed consent form
- •A total EDSS score of ≤ 7
- •Presence of IgG antibodies to the Varicella Zoster virus at screening
- •A CD19+ cell proportion of ≥ 1 % of the total lymphocyte count in patients exposed to other anti-B-cell therapies more than 6 months before signing the informed consent form
排除标准
- •A relapse occurring less than 30 days before signing the informed consent form or at screening (patients may be re-screened)
- •Intrathecal oligoclonal or monoclonal IgG production (in patients who are anti-AQP4 seronegative)
- •Other nervous system disorders (including multiple sclerosis) that can mask or affect the assessment of NMOSD symptoms
- •History of other autoimmune diseases requiring immunosuppressive therapy
- •Prior exposure to: alemtuzumab, total lymphatic irradiation, bone marrow transplantation; anti-B-cell therapy drugs, abatacept, satralizumab within 6 months prior to signing the informed consent form; mitoxantrone, cyclophosphamide, methotrexate, cyclosporine A, tacrolimus, eculizumab, tocilizumab, natalizumab, interferon beta, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate within 3 months before signing the informed consent form; immunoglobulin products within 30 days before signing the informed consent form; transfusion of blood or blood components within 30 days before signing the informed consent form; systemic corticosteroids at the time of signing the informed consent form
研究组 & 干预措施
BCD-132 (divozilimab)
Experimental
Intravenous infusion of BCD-132 every 24 weeks
干预措施: divozilimab (Biological)
结局指标
主要结局
Adjudicated annualized relapse rate [Week 24]
时间窗: Week 24
Adjudicated annualized relapse rate
次要结局
- Time to the first adjudicated relapse(Week 100)
- Adjudicated annualized relapse rate(Week 52, 100)
- Proportion of subjects without adjudicated relapses(Weeks 24, 52, 100)
- Change in the Expanded Disability Status Scale (EDSS) score(Week 24, 52, 100)
- Proportion of subjects with confirmed increase in disability(Weeks 24, 26, 48, 52, 100)
- Vision acuity change(Week 24, 52, 100)
- Change in the Timed 25-Foot (7.62 m) Walk (T25-FW) test(Up to Week 100)
- Changes in the severity of pain using a Numeric Rating Scale(Week 4, 24, 52, 100)
- Change in the quality of life using a SF-36(Week 24, 52, 100)
- CUA(Week 24)
研究者
研究点 (19)
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