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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Change in EASI From Baseline to Week 16
研究概览
简要总结
This is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (AD).
The purpose of the study is to test a new tablet (LEO 152020) to see if it improves AD and what the side effects are when compared with a placebo tablet with no medical ingredient.
During the study, there will be a 16-week treatment period during which the participants will be asked to take the tablets. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms, itch, sleep, and quality of life.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The outcome assessor is considered to be the person/people who will assess the outcome of the data/study and will in this study therefore be the sponsor.
To ensure masking across the interventions, each dose of treatment in the LEO 152020 tablet - Dose regimen 2 and LEO 152020 tablet - Dose regimen 3 arms will consist of a combination of LEO 152020 and LEO 152020 placebo tablets. In these arms, placebo will be used as a masking aid and is therefore considered neither a control nor an intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, age 18 years or older at screening.
- •Diagnosis of chronic atopic dermatitis (AD).
- •History of AD ≥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.
- •7.1≤ Eczema Area and Severity Index (EASI) ≤50 at baseline.
- •Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥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.
研究组 & 干预措施
LEO 152020 tablet - Dose regimen 1
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
干预措施: LEO 152020 tablet (Drug)
LEO 152020 tablet - Dose regimen 2
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
干预措施: LEO 152020 tablet (Drug)
LEO 152020 tablet - Dose regimen 2
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
干预措施: LEO 152020 placebo tablet (Drug)
LEO 152020 tablet - Dose regimen 3
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
干预措施: LEO 152020 tablet (Drug)
LEO 152020 tablet - Dose regimen 3
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
干预措施: LEO 152020 placebo tablet (Drug)
LEO 152020 placebo tablet
Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
干预措施: LEO 152020 placebo tablet (Drug)
结局指标
主要结局
Change in EASI From Baseline to Week 16
时间窗: Week 0 to Week 16
The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive or severe condition.
次要结局
- Number of Adverse Events From Baseline to Week 16+3 Days Per Subject(Week 0 to Week 16+3 days)