A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 8
- 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 306) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
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
- Double (Participant, Investigator)
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 a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area.
- •Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.
- •If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.
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 a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
- •Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start.
- •Subject has used any systemic methotrexate, retinoids, systemic corticosteroids [including intralesional, intra-articular, and intramuscular corticosteroids], cyclosporine or analogous products within 90 days prior to study start.
- •Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five half-lives of the biologic prior to study start.
- •Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.
研究组 & 干预措施
122-0551 Foam
122-0511 Foam, topically applied twice daily
干预措施: 122-0551 Foam (Drug)
Vehicle Foam
Vehicle Foam, topically applied twice daily
干预措施: Vehicle Foam (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 15
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
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 15)