EUCTR2020-004561-39-CZ进行中（未招募）1 期
A phase 2 trial to evaluate the efficacy and safety of orally administered LEO 152020 tablets compared with placebo tablets for up to 16 weeks of treatment in adults with moderate to severe atopic dermatitis
EO Pharma A/S0 个研究点目标入组 224 人开始时间: 2021年4月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult, age 18 years or older at baseline.
- •2. Diagnosis of chronic AD as defined by the Hanifin and Rajka (1980) criteria for AD (36).
- •3. History of AD =1 year prior to baseline.
- •4. Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments or subject for whom topical AD treatments are medically inadvisable.
- •5.7.1= EASI =50 at baseline.
- •6.vIGA AD score =3 at baseline.
- •7.BSA =5% at baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 214
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Previous treatment with an oral H4R antagonist (including LEO 152020) within 6 months prior to baseline.
- •2.Previous treatment with 3 or more systemic AD treatments prior to screening.
- •3.Women who are pregnant or lactating.
研究者
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