A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
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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.
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
Study Start Date
Actual Primary Completion Date
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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