A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 228
- 主要终点
- The number of new gadolinium CE T1 weighted lesions
研究概览
简要总结
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years.
详细描述
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years..
Part 2 of the study is open-label, Subjects completing 6 months of evaluations and study drug in Part 1 without serious study drug-related treatment emergent adverse events (TEAE) will be switched to INT131 1 mg PO QD and followed for an additional 6 months.
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)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent before any study procedures
- •Male and female subjects aged 18-50
- •Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis
- •At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart
排除标准
- •Subjects with a history or presence of chronic disease of the immune system other than RRMS
- •Subjects with a diagnosis of primary or secondary progressive multiple sclerosis
- •Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2
研究组 & 干预措施
Oral INT 131 3 mg
Oral INT-131 Double blind study
干预措施: INT131 (Drug)
Oral INT-131 1 mg
Oral INT-131 Double blind
干预措施: INT131 (Drug)
Placebo
Oral placebo Double blind
干预措施: INT131 (Drug)
结局指标
主要结局
The number of new gadolinium CE T1 weighted lesions
时间窗: asline to 6 months
The mean number of new gadolinium CE T1-weighted lesions, on monthly MRI in subjects receiving INT131 compared to Placebo from baseline to 6 months.
次要结局
未报告次要终点