A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
研究概览
简要总结
The goal of this Phase 2 clinical trial is to investigate the safety and tolerability of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.
详细描述
This Phase 2a, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and impact on measures of neuroinflammation in the central nervous system (CNS) of SUN-627 administered at 2 dose levels in participants with non-active SPMS/PPMS.
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
The Sponsor is also masked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70, inclusive
- •Diagnosis of PPMS or non-active SPMS
- •No MS relapses in the past 2 years
- •Evidence that MS has continued to get worse over time
- •A level of disability that fits the study requirements
排除标准
- •Use of certain medications or treatments before the study, or need for these treatments during the study
- •Current participation in another research study
- •Certain abnormal heart rhythm findings on ECG or other heart conditions that may increase risk
- •Certain serious or unstable medical conditions that could make the study unsafe
- •Active infection, recent infection, or a history of repeated infections
- •Additional inclusion and exclusion criteria are outlined in the full study protocol.
研究组 & 干预措施
SUN-627 Dose Level 1
SUN-627, taken orally QD
干预措施: SUN-627 (Drug)
SUN-627 Dose Level 2
SUN-627, taken orally QD
干预措施: SUN-627 (Drug)
SUN-627 Placebo
SUN-627 Placebo, taken orally QD
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
时间窗: From enrollment to the end of study at 16 weeks
次要结局
- The maximum concentration (Cmax) of SUN-627 in plasma(From enrollment to end of treatment at 12 weeks)
- Change from baseline in neuroinflammation biomarkers(From enrollment to the end of treatment at 12 weeks)