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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00941031 |
Purpose
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Plaque-type Psoriasis |
Drug: AIN457 Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis |
| Enrollment: | 404 |
| Study Start Date: | July 2009 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single | Drug: AIN457 |
| Experimental: Monthly | Drug: AIN457 |
| Experimental: Early | Drug: AIN457 |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At time of randomization, moderate to severe psoriasis as defined by:
At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from entry into the study:
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Show 69 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00941031 History of Changes |
| Other Study ID Numbers: | CAIN457A2211, EudraCT 2008-007525-39 |
| Study First Received: | July 16, 2009 |
| Last Updated: | November 1, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Iceland: Icelandic Medicines Control Agency; Israel: Ministry of Health; Japan: Ministry of Health, Labor and Welfare; Norway: Norwegian Medicines Agency; United States: Food and Drug Administration |
|
Moderate to severe chronic plaque-type psoriasis AIN457 dermatology |
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |