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

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00885196

Purpose

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	Intervention	Phase
Plaque Psoriasis	Drug: Placebo Drug: AEB071 Other: AEB071	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: AEB 071

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	336
Study Start Date:	April 2009
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AEB071 200 mg BID: Experimental	Other: AEB071
AEB071 200 mg OD: Experimental	Drug: AEB071
AEB071 100 mg BID: Experimental	Drug: AEB071
AEB071 100 mg OD: Experimental	Drug: AEB071
AEB071 50 mg BID: Experimental	Drug: AEB071
Placebo BID: Experimental	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885196

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

Argentina
Novartis Investigative Site	Recruiting
Rosario, Argentina
Novartis Investigative site	Recruiting
Buenos Aires, Argentina
Australia
Novartis Investigative site	Recruiting
Kogarah, Australia
Novartis Investigative site	Recruiting
Melbourne, Australia
Novartis Investigative site	Recruiting
Carlton, Australia
Novartis Investigative site	Recruiting
Carina Heights, Australia
Novartis Investigative site	Recruiting
Benowa, Australia
Austria
Novartis Investigative site	Recruiting
Wien, Austria
Belgium
Novartis Investigative site	Recruiting
Bruxelles, Belgium
Novartis Investigative site	Recruiting
Edegem, Belgium
Novartis Investigative site	Recruiting
Liege, Belgium
Guatemala
Novartis Investigative Site	Recruiting
Guatemala City, Guatemala
Italy
Novartis Investigative Site	Recruiting
Siena, Italy
Novartis Investigative Site	Recruiting
Verona, Italy
Novartis Investigative Site	Recruiting
Modena, Italy
Novartis Investigative Site	Recruiting
Rome, Italy
Novartis Investigative site	Recruiting
Milano, Italy
Turkey
Novartis Investigative Site	Recruiting
Izmir, Turkey
Novartis Investigative Site	Recruiting
Manisa, Turkey
Novartis Investigative Site	Recruiting
Ankara, Turkey
Novartis Investigative Site	Recruiting
Antalya, Turkey
Novartis Investigative Site	Recruiting
Gaziantep, Turkey
Venezuela
Novartis Investigative Site	Recruiting
Caracas, Venezuela

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CAEB071C2201, EUDRACT number: 2007-007160-19
Study First Received:	April 20, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00885196 History of Changes
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Office for Safety in Health Care; Belgium: Directorate general for the protection of Public health: Medicines; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Guatemala: Ministry of health; Italy: Ethics Committee; Turkey: Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:

Psoriasis
plaque psoriasis
inflammatory skin disease
scaly patches
AEB071

Study placed in the following topic categories:

Signs and Symptoms
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on August 24, 2009