A Double-Blind, Randomised, Placebo Controlled Study of the Efficacy and Safety and Pharmacokinetics of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in Itch Intensity - Numeric Rating Scale
研究概览
简要总结
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis.
详细描述
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with pruritus associated with atopic dermatitis.
Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.
Each group will compromise of approximately 100 subjects, randomized 1:1:1:1 (approximately 400 subjects in total).
All subjects will enter a two-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit four weeks after the end of the treatment period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Documented diagnosis of Atopic Dermatitis for ≥ 6 months confirmed by either the UK Working Party definition or the Hanifin definition
- •Subjects must have chronic (> 6 months) pruritus which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamines
- •Subjects must have atopic dermatitis with a severity > 3 on the IGA and EASI ≥12 at Screening visit/Visit 1
排除标准
- •Presence of, or history of, any other inflammatory dermatosis or skin conditions which may cause pruritus
- •Any other possible cause for pruritus eg systemic, neurological, idiopathic, or metabolic
- •Acute super-infection of AD lesions requiring treatment with antibiotics within 4 weeks of Visit 2
- •Inability to comply with the use of prohibited and allowed medications as described in the protocol.
研究组 & 干预措施
Orvepitant 10mg
Orvepitant 10mg tablet, once daily for 12 weeks
干预措施: Orvepitant (Drug)
Orvepitant 20mg
Orvepitant 20mg tablet, once daily for 12 weeks
干预措施: Orvepitant (Drug)
Orvepitant 30mg
Orvepitant 30mg tablet, once daily for 12 weeks
干预措施: Orvepitant (Drug)
Placebo
Placebo tablet, once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Itch Intensity - Numeric Rating Scale
时间窗: Week 12
Change from baseline in the mean worst NRS pruritus intensity scores recorded by the subject during the last 3 days of available values in the period prior to the week 12 visit
次要结局
未报告次要终点