Status:
COMPLETED
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Moderate and Severe Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00885196
Start Date
April 1 2009
Last Update
December 22 2020
Active Locations (40)
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1
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
2
Belleair Research Center, LLC
Pinellas Park, Florida, United States, 33781
3
Kansas City Dermatology, PA
Overland Park, Kansas, United States, 66215
4
Dermatology Specialists
Louisville, Kentucky, United States, 40202