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临床试验/NCT02424253
NCT02424253已完成2 期

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effects of 8 Weeks Treatment With Oral ZPL-3893787 (30 mg od x 56 Days) on Pruritus in Adult Subjects With Moderate to Severe Atopic Dermatitis

Ziarco Pharma Ltd4 个研究点 分布在 4 个国家目标入组 98 人开始时间: 2015年5月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
98
试验地点
4
主要终点
Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)

研究概览

简要总结

This was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004)
  • Eczema Area and Severity Index (EASI) of ≥12 and <
  • An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day
  • A mean pruritus score of ≥ 5 on a 0-10 scale over the 7 day Run In (Days -7 to -1)
  • Atopic dermatitis affecting ≥10% BSA

排除标准

  • AD of such severity (EASI >48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study
  • Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.
  • Have an active skin infection or any other clinically apparent infections.
  • Hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study.
  • Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the Run In.
  • Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.
  • Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.

研究组 & 干预措施

ZPL-3893787

Experimental

30 mg ZPL-3893787 orally once daily for 8 weeks.

干预措施: ZPL-3893787 (Drug)

Placebo

Placebo Comparator

1 capsule orally once daily for 8 weeks.

干预措施: Placebo (Drug)

结局指标

主要结局

Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch)

时间窗: Baseline to Week 8

The participant used the Pruritus NRS to rate his or her worst itch in the previous 12 hours. This was assessed twice daily (in the morning soon after rising and the evening prior to retiring) and recorded in the eDiary. The scale ranges from 0 (no itching) to 10 (itching as bad as can be imagined). If only 1 measurement was collected on a particular day, that score was counted as the worst measurement.

次要结局

  • Change From Baseline in Eczema Area and Severity Index (EASI) Score(Baseline to Week 8)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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