A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
研究概览
简要总结
This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.
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 a male or non-pregnant female 18 years of age or older.
- •Subject has provided written informed consent.
- •Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months.
- •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 Visit 2/Baseline.
- •Males (or their female partner) must agree to use an effective method of birth control throughout the study.
- •Subject has two similar contralateral Target Plaques.
- •Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- •Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- •Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis.
- •Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient 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 test article.
- •Other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.
研究组 & 干预措施
DUR-928 Topical Solution
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
干预措施: DUR-928 Topical Solution (Drug)
Vehicle Topical Solution
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
干预措施: Vehicle Topical Solution (Drug)
结局指标
主要结局
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
时间窗: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
次要结局
- The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)(Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported))
- The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)(Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported))
- The Change From Baseline as Assessed by the Target Plaque Area.(Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported))
- The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.(Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported))