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 - ND

• Conditions: Psoriasis; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2007-007160-19-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Key inclusion criteria: Men and women, between 18 and 75 years of age Plaque psoriasis diagnosed for at least 12 months (with or without presence of psoriatic arthritis as a comorbidity) Psoriasis Area and Severity Index (PASI) score of 10 or greater Total Body Surface Area (BSA) of 10% or greater affected by plaque psoriasis Investigator?s Global Assessment (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

Exclusion Criteria

Key exclusion criteria: Hematological abnormalities Heart rate < 50 or > 90 bpm Family history of long QT syndrome or QTcF > 470 msec History of cardiac arrhythmia, conduction abnormality, myocardial infarction, uncontrolled or unstable angina pectoris, congestive heart failure, percutaneous coronary intervention, syncope History of stroke, transient ischemic attack (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, unless they are using highly effective methods of contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified