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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00885196
First received: April 20, 2009
Last updated: August 31, 2012
Last verified: August 2012

April 20, 2009
August 31, 2012
April 2009
August 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00885196 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Moderate and Severe Plaque Psoriasis
  • Drug: Placebo
  • Drug: AEB071
  • Experimental: AEB071 200 mg BID
    Intervention: Drug: AEB071
  • Experimental: AEB071 400 mg OD
    Intervention: Drug: AEB071
  • Experimental: AEB071 300 mg BID
    Intervention: Drug: AEB071
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
Not Provided
August 2011   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Germany,   Guatemala,   Italy,   Turkey,   United Kingdom
 
NCT00885196
CAEB071C2201, EUDRACT number: 2007-007160-19
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP