A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety assessment including a MRI, neurological and physical examinations
研究概览
简要总结
Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system attacks and destroys the cells that cover and protect nerves. This study will test the safety of a new drug called RG2077 that is designed to treat MS. The study will not determine whether RG2077 is effective in treating MS, only whether it is safe to use in patients with MS.
Study hypothesis: RG2077 will arrest MS if administered early in the course of MS and decrease accumulation of lesions on MRI.
详细描述
Effective treatment of autoimmune disorders is likely to arise not from improved immunosuppression, but from improved understanding of the normal mechanisms that generate and maintain self-tolerance. RG2077 may block a T cell costimulation pathway central to the pathophysiology of MS. A total of 20 patients with MS will be enrolled in this study. Each patient participates in the study for 4 months.
The dose-escalation portion of this study evaluated the safety of a single infusion of RG2077 (CTLA4-IgG4m) in 16 patients with MS and is now complete. Patients who participated in the single infusion portion of the study were assigned to one of four groups. Each group received a different dose of RG2077. The second portion of the study will evaluate the safety of 4 doses of RG2077 in 4 additional patients. In the multiple infusion portion of the study, all patients will receive the same dose of RG2077. Patients will be monitored for possible side effects of RG2077.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
1
Participants receive Regimen 1 for 4 months
干预措施: RG2077 (CTLA4-IgG4m) (Drug)
2
Participants receive Regimen 2 for 4 months
干预措施: RG2077 (CTLA4-IgG4m) (Drug)
3
Participants receive Regimen 3 for 4 months
干预措施: RG2077 (CTLA4-IgG4m) (Drug)
4
Participants receive Regimen 4 for 4 months
干预措施: RG2077 (CTLA4-IgG4m) (Drug)
结局指标
主要结局
Safety assessment including a MRI, neurological and physical examinations
时间窗: Throughout study
次要结局
- Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI(Throughout study)