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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885196
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Moderate and Severe Plaque Psoriasis Drug: Placebo Drug: AEB071 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AEB071 200 mg BID Drug: AEB071
Experimental: AEB071 400 mg OD Drug: AEB071
Experimental: AEB071 300 mg BID Drug: AEB071
Placebo Comparator: Placebo BID Drug: Placebo

Primary Outcome Measures :
  1. 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%) [ Time Frame: to 12 weeks treatment ]

Secondary Outcome Measures :
  1. ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs [ Time Frame: up to 12 weeks treatment ]
  2. change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo [ Time Frame: up to 12 weeks treatment ]
  3. disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period [ Time Frame: in the treatment-free Follow-up Period ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885196

  Hide Study Locations
United States, Arizona
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
United States, Florida
Belleair Research Center, LLC
Pinellas Park, Florida, United States, 33781
United States, Kansas
Kansas City Dermatology, PA
Overland Park, Kansas, United States, 66215
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Central Dermatology
St. Louis, Missouri, United States, 63117
United States, South Carolina
Palmetto Clinical Trial Services
Greenville, South Carolina, United States, 29607
United States, Texas
Center for Clinical Studies
Houston, Texas, United States, 77030
Suzanne Bruce & Associates, PA
Houston, Texas, United States, 77056
United States, Virginia
Virginia Clinical Research
Norfolk, Virginia, United States, 23507
Novartis Investigative site
Buenos Aires, Argentina
Novartis Investigative site
Mendoza, Argentina
Novartis Investigative site
Benowa, Australia
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Carlton, Australia
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Kogarah, Australia
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Parkville, Australia
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Bruxelles, Belgium
Novartis Investigative site
Edegem, Belgium
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Liege, Belgium
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Berlin, Germany
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Bonn, Germany
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Erlangen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Kiel, Germany
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Leipzig, Germany
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Regensburg, Germany
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Guatemala City, Guatemala
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Milano, Italy
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Modena, Italy
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Rome, Italy
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Siena, Italy
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Verona, Italy
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Ankara, Turkey
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Gaziantep, Turkey
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Izmir, Turkey
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Manisa, Turkey
United Kingdom
Novartis Investigative site
Nuneaton, United Kingdom
Novartis Investigative site
Salford, United Kingdom
Novartis Investigative site
Southampton, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00885196     History of Changes
Other Study ID Numbers: CAEB071C2201
EUDRACT number: 2007-007160-19
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
plaque psoriasis
inflammatory skin disease
scaly patches

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases