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

December 15, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Mendoza, Argentina
        • Novartis Investigative Site
  • Australia
      • Benowa, Australia
        • Novartis Investigative Site
      • Carlton, Australia
        • Novartis Investigative Site
      • Kogarah, Australia
        • Novartis Investigative Site
      • Parkville, Australia
        • Novartis Investigative Site
  • Belgium
      • Bruxelles, Belgium
        • Novartis Investigative Site
      • Edegem, Belgium
        • Novartis Investigative Site
      • Liege, Belgium
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Bonn, Germany
        • Novartis Investigative Site
      • Erlangen, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Kiel, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Regensburg, Germany
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala
        • Novartis Investigative Site
  • Italy
      • Milano, Italy
        • Novartis Investigative Site
      • Modena, Italy
        • Novartis Investigative Site
      • Rome, Italy
        • Novartis Investigative Site
      • Siena, Italy
        • Novartis Investigative Site
      • Verona, Italy
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey
        • Novartis Investigative Site
      • Gaziantep, Turkey
        • Novartis Investigative Site
      • Izmir, Turkey
        • Novartis Investigative Site
      • Manisa, Turkey
        • Novartis Investigative Site
  • United Kingdom
      • Nuneaton, United Kingdom
        • Novartis Investigative Site
      • Salford, United Kingdom
        • Novartis Investigative Site
      • Southampton, United Kingdom
        • Novartis Investigative Site
  • United States
    • Arizona
      • Hot Springs, Arizona, United States, 71913
        • Burke Pharmaceutical Research
    • Florida
      • Pinellas Park, Florida, United States, 33781
        • Belleair Research Center, LLC
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Kansas City Dermatology, PA
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Palmetto Clinical Trial Services
    • Texas
      • Houston, Texas, United States, 77030
        • Center for Clinical Studies
      • Houston, Texas, United States, 77056
        • Suzanne Bruce & Associates, PA
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo BID
Drug: Placebo
Experimental: AEB071 200 mg BID
Drug: AEB071
Experimental: AEB071 400 mg OD
Drug: AEB071
Experimental: AEB071 300 mg BID
Drug: AEB071

What is the study measuring?

Primary Outcome Measures

Outcome 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%)
Time Frame: to 12 weeks treatment
to 12 weeks treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 12 weeks treatment
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
up to 12 weeks treatment
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
in the treatment-free Follow-up Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 20, 2009

First Posted (Estimate)

April 21, 2009

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEB071C2201
  • EUDRACT number: 2007-007160-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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