EUCTR2015-002628-14-NL进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients with Moderate-to-Severe Genital Psoriasis - IXORA-Q
未提供0 个研究点目标入组 146 人开始时间: 2016年2月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Are male or female patients of 18 years or older
- •Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline
- •Have moderate-to-severe psoriasis in the genital area
- •Have plaque psoriasis in a nongenital area at screening and baseline
- •Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area
- •Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 131
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Pustular, erythrodermic, and/or guttate forms of psoriasis
- •History of drug-induced psoriasis
- •Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments)
- •Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action
- •Cannot avoid excessive sun exposure or use of tanning booths for at least
- •4 weeks prior to baseline and during the study
- •Are currently enrolled in any other clinical trial involving an investigational
- •Serious disorder or illness other than plaque psoriasis
- •Active or history of malignant disease within 5 years prior to baseline
- •Serious infection with the last 3 months
- •Have received a live vaccine within 3 months of baseline or plan to do so during the study
- •Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year
- •Pregnant or breastfeeding (lactating) women
研究者
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