A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS
研究概览
简要总结
Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary Progressive SPMS
详细描述
Objectives:The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 i n subjects with secondary progressive MS. Secondary objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
Study Design: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo.
Subject Population: 200 subjects with Secondary Progressive SPMS MS, with an EDSS score >= 3.5 , and meeting all inclusion/exclusion criteria, will be enroll in this study. Subjects will be randomized equally to NeuroVax™ or I F A
,1 0 0 per arm .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Subject is between 18 and 50 years of age, inclusive.
- •Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.
- •Expanded Disability Status Scale (EDSS) >=score 3.5 (Appendix B).
- •Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .
- •Laboratory values within the following limits:
- •Creatinine 1 . 5 x high normal.
- •Hemoglobin
排除标准
- 未提供
结局指标
主要结局
The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS
时间窗: up to 48 weeks
次要结局
- Immunologic evaluations(48 Weeks)
- Safety Evaluation(48 Weeks)
- Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.(48 Weeks)
- Analyses of clinical relapses(48 Weeks)
- Measures of neurologic disability EDSS score(48 Weeks)