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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00885196

Collaborator

(none)

336

Enrollment

Locations

Arms

8.4

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate and Severe Plaque Psoriasis	Drug: Placebo Drug: AEB071	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Arms and Interventions

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

Outcome Measures

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%) [to 12 weeks treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burke Pharmaceutical Research	Hot Springs	Arizona	United States	71913
2	Belleair Research Center, LLC	Pinellas Park	Florida	United States	33781
3	Kansas City Dermatology, PA	Overland Park	Kansas	United States	66215
4	Dermatology Specialists	Louisville	Kentucky	United States	40202
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	Central Dermatology	Saint Louis	Missouri	United States	63117
7	Palmetto Clinical Trial Services	Greenville	South Carolina	United States	29607
8	Center for Clinical Studies	Houston	Texas	United States	77030
9	Suzanne Bruce & Associates, PA	Houston	Texas	United States	77056
10	Virginia Clinical Research	Norfolk	Virginia	United States	23507
11	Novartis Investigative site	Buenos Aires		Argentina
12	Novartis Investigative site	Mendoza		Argentina
13	Novartis Investigative site	Benowa		Australia
14	Novartis Investigative site	Carlton		Australia
15	Novartis Investigative site	Kogarah		Australia
16	Novartis Investigative site	Parkville		Australia
17	Novartis Investigative site	Bruxelles		Belgium
18	Novartis Investigative site	Edegem		Belgium
19	Novartis Investigative site	Liege		Belgium
20	Novartis Investigative site	Berlin		Germany
21	Novartis Investigative site	Bonn		Germany
22	Novartis Investigative site	Erlangen		Germany
23	Novartis Investigative site	Frankfurt		Germany
24	Novartis Investigative site	Hamburg		Germany
25	Novartis Investigative site	Kiel		Germany
26	Novartis Investigative site	Leipzig		Germany
27	Novartis Investigative site	Regensburg		Germany
28	Novartis Investigative Site	Guatemala City		Guatemala
29	Novartis Investigative site	Milano		Italy
30	Novartis Investigative Site	Modena		Italy
31	Novartis Investigative Site	Rome		Italy
32	Novartis Investigative Site	Siena		Italy
33	Novartis Investigative Site	Verona		Italy
34	Novartis Investigative Site	Ankara		Turkey
35	Novartis Investigative Site	Gaziantep		Turkey
36	Novartis Investigative Site	Izmir		Turkey
37	Novartis Investigative Site	Manisa		Turkey
38	Novartis Investigative site	Nuneaton		United Kingdom
39	Novartis Investigative site	Salford		United Kingdom
40	Novartis Investigative site	Southampton		United Kingdom