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临床试验/EUCTR2015-000892-28-SE
EUCTR2015-000892-28-SE进行中(未招募)1 期

Protocol I1F-MC-RHBSA 52-Week Multicenter, Randomized, Blinded, Parallel Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis - IXORA - S

Eli Lilly and Company0 个研究点目标入组 300 人开始时间: 2015年6月2日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
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 cyclosporine, methotrexate, or phototherapy)
  • 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 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 past year.
  • -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.

研究者

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