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Completed

NCT Number: NCT00885196

A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index 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.

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Key information

Conditions

Moderate and Severe Plaque Psoriasis Dermatitis Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

AEB071

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
First posted
Apr 21, 2009
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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