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

Novartis

Status and phase: Completed; Phase 2

Conditions: Moderate and Severe Plaque Psoriasis

Treatments: Drug: AEB071; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00885196

CAEB071C2201

EUDRACT number: 2007-007160-19

Details and patient eligibility

About

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.

Enrollment: 336 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 4 patient groups, including a placebo group

AEB071 200 mg BID

Experimental group

Treatment:

Drug: AEB071

AEB071 400 mg OD

Experimental group

Treatment:

Drug: AEB071

AEB071 300 mg BID

Experimental group

Treatment:

Drug: AEB071

Placebo BID

Placebo Comparator group

Treatment:

Drug: Placebo