A Randomized, Double Blind, Dose Ranging, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- PASI 50
研究概览
简要总结
This study will examine the safety and efficacy in subjects with moderate to severe psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) and other assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months prior to screening;
- •Plaque psoriasis covering between 10% to 30 % of body surface area (BSA);
- •PASI severity moderate to severe, scoring at least 10 but no higher than 20.
排除标准
- •The subject presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis;
- •Previously failed (due to lack of efficacy) treatment with at least one systemic biologic agent for psoriasis (e.g. ustekinumab, adalimumab, etanercept, etc);
- •The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments: 2 weeks; Systemic (non-biologic) psoriasis treatments: 4 weeks or 5 half-lives (whichever is longer); Biologic psoriasis treatments: 8 weeks or 5 half lives (whichever is longer); Phototherapy: 4 weeks;
- •The subject anticipates getting enough ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve;
- •History of cancer, with the exception of skin cancer.
研究组 & 干预措施
Placebo with crossover to VB-201 160mg
Subjects on placebo will crossover to VB-201 160 at week 16.
干预措施: VB-201 160mg (Drug)
Placebo with crossover to VB-201 160mg
Subjects on placebo will crossover to VB-201 160 at week 16.
干预措施: Placebo (Drug)
VB-201 80mg
Subjects will receive VB-201 80mg/day for 24 weeks
干预措施: VB-201 80mg (Drug)
VB-201 160mg
Subjects will received 80mg twice daily for 24 weeks
干预措施: VB-201 160mg (Drug)
结局指标
主要结局
PASI 50
时间窗: Week 16 and Week 24
The proportion of subjects in the VB-201 160 mg (80 mg BID) treatment group who achieve at least 50% improvement from the baseline PASI score at Weeks 16 and 24 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group.
次要结局
- PASI 75(Week 16 and Week 24)