NCT00885196已完成2 期
A Double Blind, Randomized, Placebo Controlled, Multicenter, Dose Finding Study of Oral AEB071 Assessing Psoriasis Area and Severity Index (PASI) Response and a Function of Dose and Treatment Duration (Primary Outcome) in Patients With Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 12
- 主要终点
- Change from baseline in plaque psoriasis as assessed by PASI response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%)
研究概览
简要总结
This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). The treatment free Follow-up Period is designed to provide additional safety data and information on disease recurrence after the last dose of the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate and Severe Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)that requires systemic therapy
- •Severity of disease meeting all of the following three criteria:
- •PASI score of 10 or greater
- •Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater
- •Investigator's Global Assessment (IGA) score of 3 or greater
排除标准
- •Hematological abnormalities
- •Heart rate < 50 or > 90 bpm when resting for 5 minutes
- •Family history of long QT syndrome
- •History of tachyarrhythmia
- •History of conduction abnormality i.e., PR > 200 msec, 2nd or 3rd degree AV block, complete left or right branch bundle block, pre-excitation syndrome
- •Uncontrolled or unstable angina pectoris; history of myocardial infarction within the previous 12 months
- •Known history of congestive heart failure
- •History of percutaneous coronary intervention (PCI) or cardiac ablation
- •History of stroke or transient ischemic attack (TIA)
- •Implanted cardiac pacemaker or defibrillator
- •History of malignancy of any organ system
- •Current guttate, generalized erythrodermic, or pustular psoriasis
- •Current drug associated psoriasis
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AEB071 200 mg BID
Experimental
干预措施: AEB071 (Drug)
AEB071 400 mg OD
Experimental
干预措施: AEB071 (Drug)
AEB071 300 mg BID
Experimental
干预措施: AEB071 (Drug)
Placebo BID
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in plaque psoriasis as assessed by PASI response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%)
时间窗: to 12 weeks treatment
次要结局
- ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs(up to 12 weeks treatment)
- change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo(up to 12 weeks treatment)
- disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period(in the treatment-free Follow-up Period)
研究者
研究点 (12)
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