Clinical trial NCT00885196: A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate and Severe Plaque Psoriasis
Keywords: Psoriasis
plaque psoriasis
inflammatory skin disease
scaly patches
AEB071
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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%)
timeFrame: to 12 weeks treatment
Secondary outcomes:
measure: ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
timeFrame: up to 12 weeks treatment
measure: change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo
timeFrame: up to 12 weeks treatment
measure: disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period
timeFrame: in the treatment-free Follow-up Period
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arizona
city: Pinellas Park
country: United States
facility: Belleair Research Center, LLC
state: Florida
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Central Dermatology
state: Missouri
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services
state: South Carolina
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce & Associates, PA
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Buenos Aires
country: Argentina
facility: Novartis Investigative site
city: Mendoza
country: Argentina
facility: Novartis Investigative site
city: Benowa
country: Australia
facility: Novartis Investigative site
city: Carlton
country: Australia
facility: Novartis Investigative site
city: Kogarah
country: Australia
facility: Novartis Investigative site
city: Parkville
country: Australia
facility: Novartis Investigative site
city: Bruxelles
country: Belgium
facility: Novartis Investigative site
city: Edegem
country: Belgium
facility: Novartis Investigative site
city: Liege
country: Belgium
facility: Novartis Investigative site
city: Berlin
country: Germany
facility: Novartis Investigative site
city: Bonn
country: Germany
facility: Novartis Investigative site
city: Erlangen
country: Germany
facility: Novartis Investigative site
city: Frankfurt
country: Germany
facility: Novartis Investigative site
city: Hamburg
country: Germany
facility: Novartis Investigative site
city: Kiel
country: Germany
facility: Novartis Investigative site
city: Leipzig
country: Germany
facility: Novartis Investigative site
city: Regensburg
country: Germany
facility: Novartis Investigative site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative site
city: Modena
country: Italy
facility: Novartis Investigative Site
city: Rome
country: Italy
facility: Novartis Investigative Site
city: Siena
country: Italy
facility: Novartis Investigative Site
city: Verona
country: Italy
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Gaziantep
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Manisa
country: Turkey
facility: Novartis Investigative Site
city: Nuneaton
country: United Kingdom
facility: Novartis Investigative site
city: Salford
country: United Kingdom
facility: Novartis Investigative site
city: Southampton
country: United Kingdom
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: