A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Moderate and Severe Plaque Psoriasis

Intervention / Treatment
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* Drug: Placebo
* Drug: AEB071


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AEB071 200 mg BID<br> | Drug: AEB071<br> <br> |
| Experimental: AEB071 400 mg OD<br> | Drug: AEB071<br> <br> |
| Experimental: AEB071 300 mg BID<br> | Drug: AEB071<br> <br> |
| Placebo Comparator: Placebo BID<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%) |  | to 12 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, plaque psoriasis, inflammatory skin disease, scaly patches, AEB071