A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 112
- 试验地点
- 32
- 主要终点
- Reduction in the cumulative number of new contrast-enhancing lesions on MRI
研究概览
简要总结
Primary Objectives:
- To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS) patients.
- To evaluate multiple doses of vatelizumab for a dose-response.
Secondary Objectives:
- To evaluate the safety and tolerability of vatelizumab compared to placebo.
- To evaluate the pharmacokinetics (PK) of vatelizumab.
详细描述
The duration of study per patient will be up to 108 weeks, including a screening period of up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up to 92 weeks.
Patients completing the 12-week treatment period may enter an optional long-term extension study in which all subjects will receive vatelizumab.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vatelizumab Dose 1
Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
干预措施: Vatelizumab (Drug)
Vatelizumab Dose 2
Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
干预措施: Vatelizumab (Drug)
Vatelizumab Dose 3
Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
干预措施: Vatelizumab (Drug)
Vatelizumab Dose 4
Vatelizumab dose 4 at Weeks 0, 2, 4 and 8
干预措施: Vatelizumab (Drug)
Placebo
Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8
干预措施: Placebo (for Vatelizumab) (Drug)
结局指标
主要结局
Reduction in the cumulative number of new contrast-enhancing lesions on MRI
时间窗: from Week 4 to Week 12
次要结局
- Pharmacokinetics: serum concentrations of vatelizumab(up to Week 32)
- Safety: proportion of patients experiencing adverse events(up to Week 104)