A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Alumis Inc
- 入组人数
- 228
- 试验地点
- 53
- 主要终点
- To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis.
详细描述
This study will consist of a 4 week screening period, 12 week treatment period, and a 4 week follow up period for a total of 20 weeks. Each participant will be randomized to receive ESK-001 or placebo daily for 12 weeks. An open label extension study will be available for those patients who complete the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total body weight >40 kg (88 lb)
- •Men and woman age 18-75
- •Men and Women must use highly effective methods of contraception for the entirety of the study
排除标准
- •History of malignancy within the last 5 years
- •Positive for HIV, Hepatitis B or C
- •History of tuberculosis
- •Diagnosis of non-plaque psoriasis
- •Patients with QTcF >450 msec (males) or >470 msec (females) at screening
- •Live vaccines
研究组 & 干预措施
ESK-001 Dose Level 1
ESK-001 administered as an oral tablet
干预措施: ESK-001 (Drug)
ESK-001 Dose Level 2
ESK-001 administered as an oral tablet
干预措施: ESK-001 (Drug)
ESK-001 Dose Level 3
ESK-001 administered as an oral tablet
干预措施: ESK-001 (Drug)
ESK-001 Dose Level 4
ESK-001 administered as an oral tablet
干预措施: ESK-001 (Drug)
ESK-001 Dose Level 5
ESK-001 administered as an oral tablet
干预措施: ESK-001 (Drug)
Placebo
Placebo administered as an oral tablet
干预措施: Placebo (Drug)
结局指标
主要结局
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
时间窗: 12 weeks
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score
次要结局
- To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients(12 weeks)
- To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score(12 weeks)
- To Characterize the Pharmacokinetics (PK) of ESK-001(14 weeks)