EUCTR2011-002970-22-PL进行中（未招募）1 期
A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long-Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients with Moderate-to-Severe Plaque 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1189
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
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 <5 half-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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