EUCTR2015-000892-28-IT进行中（未招募）1 期
A 52-Week Multicenter, Randomized, Blinded, Parallel Group StudyComparing the Efficacy and Safety of Ixekizumab to Ustekinumab inPatients with Moderate to Severe Plaque Psoriasis - IXORA - S
ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 个研究点目标入组 300 人开始时间: 2018年2月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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 at least 18 years of age
- •-Have had moderate to severe plaque psoriasis for at least 6 months
- •-Have had a failure, contraindication, or intolerability to at least 1 systemic therapy (including yclosporine, methotrexate, or
- •phototherapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Have forms of psoriasis other than plaque psoriasis.
- •-Have recently received certain treatments for their psoriasis (in
- •particular within the last 4 weeks but the restriction can go up to 12
- •months for some treatments).
- •-Have received ustekinumab.
- •-Have already been treated with ixekizumab or another drug with a
- •similar mode of action.
- •-Have received excessive sun exposure or have used tanning booths
- •within 4 weeks prior to receiving treatment in this study or expect to do
- •so during the study.
- •-Have recently received a live vaccine (within 12 weeks prior to
- •receiving treatment in this study) or plan to do so during the study.
- •-Have had a vaccination with Bacillus Calmette-Guerin (BCG) within the
- •-Have an active or recent infection.
- •-Have active or dormant tuberculosis.
- •-Have a compromised immune system.
- •-Have another disease which is not currently under control, including
- •heart disease, uncontrolled arterial hypertension, mental illness, and
- •other diseases.
- •Have either a current diagnosis or a recent history of malignant disease.
- •-Have allergies to certain treatments or latex.
- •-Are pregnant or breastfeeding.
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