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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00885196




Registration number
NCT00885196
Ethics application status
Date submitted
20/04/2009
Date registered
21/04/2009
Date last updated
22/12/2020

Titles & IDs
Public title
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
Scientific 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
Secondary ID [1] 0 0
EUDRACT number: 2007-007160-19
Secondary ID [2] 0 0
CAEB071C2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate and Severe Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: AEB071 200 mg BID -

Experimental: AEB071 400 mg OD -

Experimental: AEB071 300 mg BID -

Placebo comparator: Placebo BID -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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%)
Timepoint [1] 0 0
to 12 weeks treatment
Secondary outcome [1] 0 0
ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Timepoint [1] 0 0
up to 12 weeks treatment
Secondary outcome [2] 0 0
change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo
Timepoint [2] 0 0
up to 12 weeks treatment
Secondary outcome [3] 0 0
disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period
Timepoint [3] 0 0
in the treatment-free Follow-up Period

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
336
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative site - Benowa
Recruitment hospital [2] 0 0
Novartis Investigative site - Carlton
Recruitment hospital [3] 0 0
Novartis Investigative site - Kogarah
Recruitment hospital [4] 0 0
Novartis Investigative site - Parkville
Recruitment postcode(s) [1] 0 0
- Benowa
Recruitment postcode(s) [2] 0 0
- Carlton
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Mendoza
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Liege
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Bonn
Country [17] 0 0
Germany
State/province [17] 0 0
Erlangen
Country [18] 0 0
Germany
State/province [18] 0 0
Frankfurt
Country [19] 0 0
Germany
State/province [19] 0 0
Hamburg
Country [20] 0 0
Germany
State/province [20] 0 0
Kiel
Country [21] 0 0
Germany
State/province [21] 0 0
Leipzig
Country [22] 0 0
Germany
State/province [22] 0 0
Regensburg
Country [23] 0 0
Guatemala
State/province [23] 0 0
Guatemala City
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Modena
Country [26] 0 0
Italy
State/province [26] 0 0
Rome
Country [27] 0 0
Italy
State/province [27] 0 0
Siena
Country [28] 0 0
Italy
State/province [28] 0 0
Verona
Country [29] 0 0
Turkey
State/province [29] 0 0
Ankara
Country [30] 0 0
Turkey
State/province [30] 0 0
Gaziantep
Country [31] 0 0
Turkey
State/province [31] 0 0
Izmir
Country [32] 0 0
Turkey
State/province [32] 0 0
Manisa
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Nuneaton
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Salford
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00885196