Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 117
- 试验地点
- 9
- 主要终点
- Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
研究概览
简要总结
An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LEO 90100
干预措施: LEO 90100 (Drug)
结局指标
主要结局
Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
时间窗: From baseline to Week 4
Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
时间窗: From baseline to Week 4
Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
Number of Subjects With Adverse Events (AEs)
时间窗: From Week -1 to Week 8
Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
时间窗: From baseline to Week 4
Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
时间窗: 30 minutes after ACTH-challenge at Week 4
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
次要结局
- Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body(Week 4)
- Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4(Week 4)
- Percentage Change in PASI From Baseline to Week 4(From baseline to Week 4)
- Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4(From baseline to Week 4)
- Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp(Week 4)
- Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4(Week 4)
- Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4(30 and 60 minutes after ACTH-challenge at Week 4)
- Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4(From baseline to Week 4)