A Phase 1b, Randomised, Controlled, Observer-blinded Trial to Assess Safety, Tolerability and Pharmacodynamic Effects of LEO 134310 Cutaneous Solution in Descaled Skin of Adults With Chronic Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Overall number of treatment-emergent adverse events.
研究概览
简要总结
To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.
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
- Single (Investigator)
盲法说明
The trial will be performed investigator-blind with random assignment of the 4 Investigational Medicinal Products (IMPs), the placebo and the active comparator.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.
- •Men or women of non-child bearing potential.
排除标准
- •Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
- •According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.
研究组 & 干预措施
LEO 134310 vehicle
Once daily application
干预措施: LEO 134310 vehicle (Drug)
LEO 134310 Dose A
Once daily application
干预措施: LEO 134310 (Drug)
LEO 134310 Dose B
Once daily application
干预措施: LEO 134310 (Drug)
LEO 134310 Dose C
Once daily application
干预措施: LEO 134310 (Drug)
LEO 134310 Dose D
Once daily application
干预措施: LEO 134310 (Drug)
0.1% betamethasone valerate ointment (class III steroid)
Once daily application
干预措施: 0.1% betamethasone valerate ointment (class III steroid) (Drug)
结局指标
主要结局
Overall number of treatment-emergent adverse events.
时间窗: Up to Day 19
Number of treatment-emergent application site reactions, by treatment.
时间窗: Up to Day 19
Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.
时间窗: Up to Day 12
measured in degrees celsius
Change from baseline to Day 4, Day 8 and Day 12 in pulse.
时间窗: Up to Day 12
measured in beats per minute
Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters
时间窗: Up to Day 12
red blood cells, white blood cells, hemoglobin, hematocrit, MCH, MMCV, MCHC, platelets, white cell differentials, measure in SI units
Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters
时间窗: Up to Day 12
sodium, potassium, chloride, bicarbonate, blood urea nitrogen, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gammaGT, uric acid, calcium, phosphate, albumin, triglycerides, cholesterol, lactate dehydrogenase, total protein, creatinine, total bilirubin, direct bilirubin, indirect bilirubin
Number of subjects with abnormal clinically significant findings of physical examination at Day 12.
时间窗: Up to Day 12
Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant'
Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters
时间窗: Up to Day 12
Single parameters only to be listed if deviation from usual urine dip test, e.g., sediment, leucocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin
Number of subjects with abnormal clinical significant ECG evaluation
时间窗: Up to Day 12
Evaluation of 12-lead ECG (overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant')
Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.
时间窗: Up to Day 12
measured in mmHg
次要结局
- Change from baseline to Day 4, Day 8 and Day 12 in psoriatic infiltrate thickness (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography)(12 days)
- Change from baseline to Day 12 in disease severity(12 days)