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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00885196
Ethics application status
Date submitted
20/04/2009
Date registered
20/04/2009
Date last updated
15/11/2016

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
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
Treatment: Drugs - Placebo
Treatment: Drugs - AEB071
Treatment: Drugs - Placebo
Treatment: Drugs - AEB071

Experimental: AEB071 200 mg BID -

Experimental: AEB071 400 mg OD -

Experimental: AEB071 300 mg BID -

Placebo Comparator: Placebo BID -

Experimental: AEB071 200 mg BID -

Experimental: AEB071 400 mg OD -

Experimental: AEB071 300 mg BID -

Placebo Comparator: Placebo BID -


Treatment: Drugs: Placebo


Treatment: Drugs: AEB071


Treatment: Drugs: Placebo


Treatment: Drugs: AEB071


Intervention code [1] 0 0
Treatment: Drugs
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
Primary outcome [2] 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 [2] 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
Secondary outcome [4] 0 0
ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Timepoint [4] 0 0
up to 12 weeks treatment
Secondary outcome [5] 0 0
change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo
Timepoint [5] 0 0
up to 12 weeks treatment
Secondary outcome [6] 0 0
disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period
Timepoint [6] 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00885196
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

Summary results
Other publications