Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 464
- 试验地点
- 115
- 主要终点
- Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
研究概览
简要总结
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
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
- •Adult males and females
- •Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
- •Signed inform consent prior to initiation of any study-mandated procedure.
排除标准
- •A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.
- •Patients currently treated for an autoimmune disorder other than MS.
- •Contraindications for MRI.
- •Ongoing bacterial, viral, or fungal infection.
- •History or presence of malignancy.
- •Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
研究组 & 干预措施
ACT-128800 Dose 1
ACT-128800 Dose 1
干预措施: ACT-128800 Dose 1 (Drug)
ACT-128800 Dose 2
ACT-128800 Dose 2
干预措施: ACT-128800 Dose 2 (Drug)
ACT-128800 Dose 3
ACT-128800 Dose 3
干预措施: ACT-128800 Dose 3 (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
时间窗: From Week 12 to 24
Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.
次要结局
- Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24(Baseline to Week 24)
- Annualized Confirmed Relapse Rate(Up to 24 weeks)