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

Primary Purpose

Moderate and Severe Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
AEB071
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate and Severe Plaque Psoriasis focused on measuring Psoriasis, plaque psoriasis, inflammatory skin disease, scaly patches, AEB071

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Burke Pharmaceutical Research
  • Belleair Research Center, LLC
  • Kansas City Dermatology, PA
  • Dermatology Specialists
  • Massachusetts General Hospital
  • Central Dermatology
  • Palmetto Clinical Trial Services
  • Center for Clinical Studies
  • Suzanne Bruce & Associates, PA
  • Virginia Clinical Research
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AEB071 200 mg BID

AEB071 400 mg OD

AEB071 300 mg BID

Placebo BID

Arm Description

Outcomes

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%)

Secondary Outcome Measures

ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo
disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period

Full Information

First Posted
April 20, 2009
Last Updated
December 15, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00885196
Brief Title
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate and Severe Plaque Psoriasis
Keywords
Psoriasis, plaque psoriasis, inflammatory skin disease, scaly patches, AEB071

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AEB071 200 mg BID
Arm Type
Experimental
Arm Title
AEB071 400 mg OD
Arm Type
Experimental
Arm Title
AEB071 300 mg BID
Arm Type
Experimental
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
AEB071
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arizona
ZIP/Postal Code
71913
Country
United States
Facility Name
Belleair Research Center, LLC
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Kansas City Dermatology, PA
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Central Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Palmetto Clinical Trial Services
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Suzanne Bruce & Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Novartis Investigative site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative site
City
Mendoza
Country
Argentina
Facility Name
Novartis Investigative site
City
Benowa
Country
Australia
Facility Name
Novartis Investigative site
City
Carlton
Country
Australia
Facility Name
Novartis Investigative site
City
Kogarah
Country
Australia
Facility Name
Novartis Investigative site
City
Parkville
Country
Australia
Facility Name
Novartis Investigative site
City
Bruxelles
Country
Belgium
Facility Name
Novartis Investigative site
City
Edegem
Country
Belgium
Facility Name
Novartis Investigative site
City
Liege
Country
Belgium
Facility Name
Novartis Investigative site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative site
City
Bonn
Country
Germany
Facility Name
Novartis Investigative site
City
Erlangen
Country
Germany
Facility Name
Novartis Investigative site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigative site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative site
City
Kiel
Country
Germany
Facility Name
Novartis Investigative site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative site
City
Regensburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigative site
City
Milano
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
Country
Italy
Facility Name
Novartis Investigative Site
City
Rome
Country
Italy
Facility Name
Novartis Investigative Site
City
Siena
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
Country
Italy
Facility Name
Novartis Investigative Site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Gaziantep
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigative Site
City
Manisa
Country
Turkey
Facility Name
Novartis Investigative site
City
Nuneaton
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Salford
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6743
Description
Results for CAEB071C2201 from the Novartis Clinical Trials Results Website

Learn more about this trial

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

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