A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
- Conditions
- Moderate and Severe Plaque Psoriasis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00885196
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AEB071 200 mg BID AEB071 - Placebo BID Placebo - AEB071 400 mg OD AEB071 - AEB071 300 mg BID AEB071 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (12)
Kansas City Dermatology, PA
🇺🇸Overland Park, Kansas, United States
Palmetto Clinical Trial Services
🇺🇸Greenville, South Carolina, United States
Novartis Investigative Site
🇹🇷Manisa, Turkey
Suzanne Bruce & Associates, PA
🇺🇸Houston, Texas, United States
Virginia Clinical Research
🇺🇸Norfolk, Virginia, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arizona, United States
Belleair Research Center, LLC
🇺🇸Pinellas Park, Florida, United States
Dermatology Specialists
🇺🇸Louisville, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Central Dermatology
🇺🇸Saint Louis, Missouri, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Novartis Investigative site
🇬🇧Southampton, United Kingdom