A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00885196
First received: April 20, 2009
Last updated: August 31, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Moderate and Severe Plaque Psoriasis |
Drug: Placebo Drug: AEB071 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
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%) [ Time Frame: to 12 weeks treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 336 |
| Study Start Date: | April 2009 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885196
Show 40 Study Locations
Show 40 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00885196 History of Changes |
| Other Study ID Numbers: | CAEB071C2201, EUDRACT number: 2007-007160-19 |
| Study First Received: | April 20, 2009 |
| Last Updated: | August 31, 2012 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belgium: Directorate general for the protection of Public health: Medicines Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Guatemala: Ministry of health Italy: Ethics Committee Turkey: Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Psoriasis plaque psoriasis inflammatory skin disease scaly patches AEB071 |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013