A Double-Blind, Randomized, Multicenter, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Efficacy and Safety of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis Receiving Up to Four Weeks of Twice-Daily Treatment (Study 305)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 12
- 主要终点
- Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)
研究概览
简要总结
This Phase 3 study (Study 305) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Spray or Vehicle Spray) to all psoriasis plaques within the designated Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies the subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks (Study Day 15).
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 is male or non-pregnant female and is at least 18 years of age at time of informed consent.
- •Subject has provided written informed consent.
- •Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas).
- •Subject has moderate to severe plaque psoriasis.
- •Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- •Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at the Baseline Visit.
排除标准
- •Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- •Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
- •Subject has palmar/plantar psoriasis.
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has been previously enrolled in this study and treated with a test article.
- •Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
研究组 & 干预措施
Drug: 188-0551 Spray
188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
干预措施: 188-0551 Spray (Drug)
Vehicle Spray
Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
干预措施: Vehicle Spray (Drug)
结局指标
主要结局
Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)
时间窗: Day 29
The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29).
次要结局
- Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)(Day 29)
- Change from Baseline in pruritus score(Day 29)
- IGA "treatment success" at Day 15(Day 15)