NCT02601469已完成2 期
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients With Plaque Psoriasis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants With HPA Axis Suppression
研究概览
简要总结
An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
详细描述
- The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe plaque psoriasis
- To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA affected
- •Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
- •Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response
排除标准
- •Patients under 2 years of age.
- •Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.
- •Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).
- •Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response
研究组 & 干预措施
DSXS1503
Experimental
administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
干预措施: DSXS (Drug)
结局指标
主要结局
Number of Participants With HPA Axis Suppression
时间窗: 28 days
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
次要结局
未报告次要终点
研究者
研究点 (1)
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