A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety and Efficacy of Emulsion Formulation U0267 , Versus Vehicle Foam in Subjects With Plaque-type Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 12
- 主要终点
- Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment
研究概览
简要总结
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects at least 12 years old and in good general health.
- •Mild to moderate plaque-type psoriasis
排除标准
- •Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations
- •History of hypercalcemia or of vitamin D toxicity.
- •Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.
- •Other serious skin disorder or any chronic medical condition that is not well controlled.
- •Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment.
- •Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment.
- •Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment.
- •Use of any investigational therapy within 4 weeks of enrollment.
- •Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.
研究组 & 干预措施
U0267 foam
U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
干预措施: U0267 Foam (Drug)
Vehicle foam
Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
干预措施: Vehicle foam (Drug)
结局指标
主要结局
Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment
时间窗: 8 weeks
Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
次要结局
- Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8(8 Weeks)
- Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2-grade Improvement From Baseline at Week 8(8 Weeks)
- Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8(8 Weeks)
- Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8(8 Weeks)
- Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)(8 Weeks)