NCT06557174尚未招募1 期
A Phase Ib/III Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.0 个研究点目标入组 116 人开始时间: 2024年10月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 主要终点
- Proportion of relapse-free patients
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
详细描述
This is a phase Ib/III study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg dose level, Phase III study is a multi-center, randomized, double-blind, positive control study to evaluate the safety and efficacy of IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years, inclusive, at the time of informed consent
- •Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
- •Confirmation of NMOSD diagnosis with AQP4+ antibodies
- •The EDSS score should be ≤7.0
- •Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening
排除标准
- •Have received rituximab or other anti-CD20 drugs treatment within 6 months
- •Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.
- •Females who are pregnant or lactating.
- •Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).
研究组 & 干预措施
IMC-002
Experimental
intravenous injection of 0.8mg/kg、1.2mg/kg
干预措施: IMC-002 (Drug)
mycophenolate mofetil， MMF
Active Comparator
mycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral.
干预措施: mycophenolate mofetil， MMF (Drug)
结局指标
主要结局
Proportion of relapse-free patients
时间窗: Up to Week 24
次要结局
- Time to first relapse (TFR)(Up to Week 24)
- Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study(Baseline (Day -28 to Day -1) to Week 24)
研究者
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