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

Moderate and Severe Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885196
• Other study ID #: CAEB071C2201
• Secondary ID: EUDRACT number:
• Status: Completed
• Phase: Phase 2
• Start date: April 2009

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Moderate and Severe Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Placebo

• AEB071

Locations

Country	Name	City	State
Argentina	Novartis Investigative site	Buenos Aires
Argentina	Novartis Investigative site	Mendoza
Australia	Novartis Investigative site	Benowa
Australia	Novartis Investigative site	Carlton
Australia	Novartis Investigative site	Kogarah
Australia	Novartis Investigative site	Parkville
Belgium	Novartis Investigative site	Bruxelles
Belgium	Novartis Investigative site	Edegem
Belgium	Novartis Investigative site	Liege
Germany	Novartis Investigative site	Berlin
Germany	Novartis Investigative site	Bonn
Germany	Novartis Investigative site	Erlangen
Germany	Novartis Investigative site	Frankfurt
Germany	Novartis Investigative site	Hamburg
Germany	Novartis Investigative site	Kiel
Germany	Novartis Investigative site	Leipzig
Germany	Novartis Investigative site	Regensburg
Guatemala	Novartis Investigative Site	Guatemala City
Italy	Novartis Investigative site	Milano
Italy	Novartis Investigative Site	Modena
Italy	Novartis Investigative Site	Rome
Italy	Novartis Investigative Site	Siena
Italy	Novartis Investigative Site	Verona
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Gaziantep
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Manisa
United Kingdom	Novartis Investigative site	Nuneaton
United Kingdom	Novartis Investigative site	Salford
United Kingdom	Novartis Investigative site	Southampton
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Palmetto Clinical Trial Services	Greenville	South Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arizona
United States	Center for Clinical Studies	Houston	Texas
United States	Suzanne Bruce & Associates, PA	Houston	Texas
United States	Dermatology Specialists	Louisville	Kentucky
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Kansas City Dermatology, PA	Overland Park	Kansas
United States	Belleair Research Center, LLC	Pinellas Park	Florida
United States	Central Dermatology	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Germany,  Guatemala,  Italy,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo		up to 12 weeks treatment
Secondary	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

External Links

•   Results for CAEB071C2201 from the Novartis Clinical Trials Results Website