NCT00384098已完成2 期
A Randomized, Double-blind, Parallel-group, 4-arm, 12-week Study to Evaluate the Safety and Efficacy of Topically Applied CTA018 vs Vehicle for the Treatment of Adult Subjects With Chronic Plaque Psoriasis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 29
- 主要终点
- The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
研究概览
简要总结
Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.
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
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
- •clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet
- •at least two evaluable plaques with CPSS >/= 6
- •baseline PSGA >/= 2
- •women of childbearing potential msut agree to use an effective form of contraception
排除标准
- •cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
- •cannot have concomitant serious illness/condition that may interfere with participation in the study
- •cannot have used topical therapy within 2 weeks prior to baseline visit
- •cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit
- •cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study
- •cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit
- •cannot have a history of hypercalcemia or kidney stones
- •cannot be unable or unwilling to discontinue calcium and/or vitamin D supplementation during the study
- •cannot be pregnant or a nursing mother
- •cannot be participating in or have participated in an interventional study within 30 days of study start
结局指标
主要结局
The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
次要结局
- Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.
研究者
研究点 (29)
Loading locations...
相似试验
已完成
1 期
Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis VulgarisPsoriasis VulgarisNCT01743118Circassia Limited24
已完成
2 期
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With PsoriasisPsoriasisNCT01837420Vascular Biogenics Ltd. operating as VBL Therapeutics194
已完成
不适用
The Effect of Vitamin D Supplementation on Psoriasis SeverityPsoriasisVitamin D DeficiencyNCT03334136University Hospital of North Norway115
已完成
3 期
The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body PsoriasisPsoriasisNCT01139580Stiefel, a GSK Company363
终止
4 期
Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? The D-Vex Pilot StudyAtopic DermatitisNCT03257215Murdoch Childrens Research Institute13