A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Sequential Group, Multiple-Dose Escalation Study to Evaluate the Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 11
- 主要终点
- Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.
详细描述
Following completion of at least 1 week of study drug for all subjects in group 1, the Sponsor will review the safety information of these subjects prior to enrolling off-treatment subjects into the next dose group. Dose escalation will continue in this manner (unless stopping criteria are met) until all groups have completed 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject has moderate to severe plaque psoriasis for 6 months or longer with at least 10% Body Surface Area (BSA) affected
- •Subject must be a candidate for phototherapy and/or systemic therapy
排除标准
- •Subject has non-plaque psoriasis or drug-induced psoriasis
- •Subject is on systemic psoriasis therapy within 56 days or 5 half-lives, whichever is longer, prior to first dose of study drug
- •Subject has a positive TB skin test within 3 months of screening or at screening
- •Subject has an abnormal chest x-ray
研究组 & 干预措施
Group 2
low dose
干预措施: peficitinib (Drug)
Group 1
lowest dose
干预措施: peficitinib (Drug)
Group 3
high dose
干预措施: peficitinib (Drug)
Group 4
highest dose
干预措施: peficitinib (Drug)
Group 5
medium dose
干预措施: peficitinib (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessed from baseline to end of treatment by recording adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
时间窗: 6 weeks
Change from baseline to the end of treatment in Psoriasis Area Severity Index (PASI) score
时间窗: 6 weeks
次要结局
- Change from baseline to end of treatment in percent body surface area (BSA)(6 weeks)
- Change from baseline to end of treatment in Physicians Static Global Assessment (PSGA)(6 weeks)
- Success of the treatment of psoriasis as measured by a Physician's Static Global Assessment (PSGA) of Almost Clear or Clear(6 weeks)