A double blind, randomized, placebo controlled, multicenter, dose finding study of oral AEB071 assessing Psoriasis Area and Severity Index (PASI) respoonse as a function of dose and treatment duration (primary outcome) in patients with plaque psoriasis - C2201

• Conditions: Plaque psoriasis diagnosed for at least 12 months with or without psoriatic arthritis

• Registration Number: EUCTR2007-007160-19-AT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

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)

- 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

- 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