Status:
COMPLETED
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be ran...
Eligibility Criteria
Inclusion
- Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
- Coverage of the body surface area (BSA) of 10% or more with plaques
- A score of 3 or more on the IGA (Investigator Global Assessment) scale
- A PASI score of at least 12 at baseline;
Exclusion
- Have forms of psoriasis other than the required "plaque psoriasis"
- Women of childbearing potential
- Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
- Previous treatment with this investigational drug
- Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities
- Other protocol-defined inclusion/exclusion criteria may have applied.
Key Trial Info
Start Date :
September 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00770965
Start Date
September 10 2008
End Date
September 17 2009
Last Update
March 12 2018
Active Locations (5)
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1
Novartis Investigative Site
Santa Monica, California, United States, 90404
2
Novartis Investigative Site
Louisville, Kentucky, United States, 40217
3
Novartis Investigative Site
High Point, North Carolina, United States, 27262
4
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16634