EUCTR2007-007160-19-DE进行中（未招募）不适用
A double blind, randomized, placebo controlled, multicenter, dose finding study of oral AEB071 assessing Psoriasis Area and Severity Index (PASI) response as a function of dose and treatment duration (primary outcome) in patients with plaque psoriasis - C2201
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 336
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
- •Men and women, between 18 and 75 years of age.
- •Moderate to severe plaque psoriasis diagnosed for at least 12 months (with or w/o presence of psoriatic arthritis as a comorbidity) requiring systemic therapy.
- •PASI score of 10 or greater.
- •BSA of 10% or greater affected by plaque psoriasis.
- •IGA score of 3 or greater.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hematological abnormalities.
- •Heart rate < 50bpm or > 90bpm.
- •Family history of long QT syndrome or QTcF > 470msec.
- •History of cardiac arrhythmia, conduction abnormality, myocardial infarction, uncontrolled or unstable angina pectoris, CHF, PCI, syncope.
- •History of stroke, TIA.
- •History of major gastrointestinal surgery.
- •Serum potassium level outside normal range.
- •Known to be immunocompromised.
- •Abnormalities in liver function tests.
- •Active systemic infections other than common cold.
- •History of malignancy.
- •Current other forms of psoriasis.
- •Use of prohibited treatments/medications.
- •Pregnant or nursing (lactating) women.
- •Women of childbearing potential (including women with bilateral tubal litigation), unless they are using highly effective methods of contraception.
研究者
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