A Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Patients With Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Alumis Inc
- 入组人数
- 165
- 试验地点
- 76
- 主要终点
- To assess the safety and tolerability of long-term ESK-001 treatment
研究概览
简要总结
This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.
详细描述
This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have completed a prior ESK-001 study
- •Men and Women must use highly effective methods of contraception for the entirety of the study
排除标准
- •Pregnancy
- •Received a prohibited concomitant medication
研究组 & 干预措施
envudeucitinib Dose Level 1
envudeucitinib administered as an oral tablet
干预措施: envudeucitinib (Drug)
envudeucitinib Dose Level 2
envudeucitinib administered as an oral tablet
干预措施: envudeucitinib (Drug)
结局指标
主要结局
To assess the safety and tolerability of long-term ESK-001 treatment
时间窗: Approximately 3 years
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
次要结局
- To assess the long-term efficacy of ESK-001(Approximately 3 years)
- To assess the change in quality of life (QoL) with long-term ESK-001 administration(Approximately 3 years)
- To assess the pharmacokinetics (PK) of ESK-001 (ctrough)(2 years)