EUCTR2011-002970-22-IT进行中（未招募）1 期
A Multicenter Study with a Randomized, Double-Blind,Placebo-Controlled Induction Dosing Period Followed bya Randomized Maintenance Dosing Period and a Long-Term Extension Period to Evaluate the Efficacy andSafety of LY2439821 in Patients with Moderate-to-SeverePlaque Psoriasis - UNCOVER-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,296
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
- •Have active plaque psoriasis covering at least 10% body surface area and a PASI score of 12 •Candidate for phototherapy and/or systemic therapy •Have a sPGA score of at least 3
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 296
排除标准
- •Have pustular, erythrodermic, and/or guttate forms of psoriasis •Have a history of drug-induced psoriasis •Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline •Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; ustekinumab <8 months; rituximab or efalizumab <12 months; or any other biologic agent <5half-lives prior to baseline •Have received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 [mild, such as desonide] or 7 [least potent, such as hydrocortisone] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia) •Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study •Have ever received natalizumab or other agents that target alpha-4- integrin •Have participated in any study with IL-17 antagonist including LY2439821 •Have another serious disorder or illness •Have suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months •Have a history of uncontrolled high blood pressure •Have clinical laboratory test results at entry that are outside the normal reference range •Are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug •Are a woman who is lactating or breast feeding •Are a woman and could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study •Are a post menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months •Are a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate •Are a male, you must agree to reduce the risk of your female partner becoming pregnant during the study
研究者
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