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22日最近更新: 2018年1月8日

研究概览

暂无简介。

•-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

•-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.

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