JPRN-jRCT2031210485已完成2 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
Kikuchi Aki0 个研究点目标入组 224 人开始时间: 2021年12月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Adult, age 18 years or older at screening.
- •- Diagnosis of chronic atopic dermatitis (AD).
- •- History of AD more than or equal to 1 year prior to baseline.
- •- 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.
- •- Eczema Area and Severity Index (EASI) between 7.1 and 50 at baseline.
- •- Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score more than or equal to 3 at baseline
排除标准
- •- Previous treatment with an oral histidine 4 receptor (H4R) antagonist (including LEO 152020) within 6 months prior to baseline.
- •- Previous treatment with 3 or more systemic AD treatments prior to screening.
- •- Women who are pregnant, intend to become pregnant, or are lactating
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