NCT01838499终止2 期
A Phase IIa Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 224
- 试验地点
- 27
- 主要终点
- 1) Percentage of Subjects Achieving a Clinically Relevant Response in Physician Global Assessment (PGA), With Score 0,1 or 2 From Baseline to 12 Weeks
研究概览
简要总结
The purpose of this study is to gain initial evidence for the safety, tolerability and efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis suppurativa
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
- 否
入选标准
- •Hidradenitis suppurativa (HS) (moderate to severe)
- •Diagnosis of HS for at least 1 year
- •At least 5 active inflammatory lesions in at least 2 locations
- •On a stable dose of antibiotics and/or analgesics for at least 4 weeks (if already taking these medications)
- •Average pain score of 3-9.
排除标准
- •History of cyclic neutropenia
- •Laboratory assessment abnormalities
- •Underlying disorder considered unsuitable for inclusion
- •Other skin diseases that may interfere with HS assessment
- •Pregnancy or planning for pregnancy
结局指标
主要结局
1) Percentage of Subjects Achieving a Clinically Relevant Response in Physician Global Assessment (PGA), With Score 0,1 or 2 From Baseline to 12 Weeks
时间窗: 12 weeks
Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12
次要结局
- 2) Subject's Global Impression of Change Reported on PGIC Scale (1-7 Point Scale Ranging From 1 "Very Much Improved" to 7 "Very Much Worse")(12 weeks)
- Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain(12 weeks)
研究者
研究点 (27)
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