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
  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
Moderate and Severe Plaque Psoriasis
Drug: Placebo
Drug: AEB071
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ]

Enrollment: 336
Study Start Date: April 2009
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 40 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00885196     History of Changes
Other Study ID Numbers: CAEB071C2201, EUDRACT number: 2007-007160-19
Study First Received: April 20, 2009
Last Updated: August 31, 2012
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: Federal Agency for Medicines and Health Products, FAMHP
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

Keywords provided by Novartis:
Psoriasis
plaque psoriasis
inflammatory skin disease
scaly patches
AEB071

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014