NCT01634087已完成2 期
A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of Escalating Doses of Oral Itacitinib in Subjects With Stable, Chronic Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
研究概览
简要总结
This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
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, Care Provider, Investigator)
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
- •Subjects with chronic plaque psoriasis aged 18 to 75 who have had insufficient response to topical agents, and who meet the psoriasis assessment expectations as defined in the study protocol
排除标准
- •Females who are pregnant or breastfeeding
- •Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively
- •Subjects treated with leflunomide or other biological therapies to treat psoriasis and all JAK-STAT inhibitors within 12 weeks prior to first dose of study drug
研究组 & 干预措施
600 mg once a day Placebo
Experimental
干预措施: Placebo (Drug)
100 mg QD Itacitinib
Experimental
干预措施: Itacitinib (Drug)
100 mg QD Placebo
Experimental
干预措施: Placebo (Drug)
200 mg QD Itacitinib
Experimental
干预措施: Itacitinib (Drug)
200 mg QD Placebo
Experimental
干预措施: Placebo (Drug)
200 mg BID Itacitinib
Experimental
干预措施: Itacitinib (Drug)
200 mg BID Placebo
Experimental
干预措施: Placebo (Drug)
600 mg once a day Itacitinib
Experimental
干预措施: Itacitinib (Drug)
结局指标
主要结局
The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
时间窗: Approximately 28 days.
Safety and tolerability of itacitinib as measured by changes in frequency and severity of adverse events, ECGs, physical examination, vital signs, and clinical laboratory evaluations.
时间窗: Approximately two months.
次要结局
- Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit.(Day 1, Day 8, Day 15, Day 28 and Day 56 (approximately two months).)
- Preliminary Pharmacokinetic (PK) collections.(Following 15 days of therapy.)
研究者
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