Status:
COMPLETED
Multiple-loading Dose Regimen Study 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
Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaqu...
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 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 apply
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00805480
Start Date
December 1 2008
End Date
September 1 2010
Last Update
February 10 2015
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