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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00885196

Enrollment

336

Registered

2009-04-21

Start date

2009-04-30

Completion date

Unknown

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate and Severe Plaque Psoriasis

Keywords

Psoriasis, plaque psoriasis, inflammatory skin disease, scaly patches, AEB071

Brief 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.

Interventions

DRUGPlacebo

DRUGAEB071

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Argentina, Australia, Belgium, Germany, Guatemala, Italy, Turkey (Türkiye), United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026