Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Phase II Single Dose, Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
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 randomized to receive either AIN457 at one of the three doses studied or placebo.
Inclusion Criteria:
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 Criteria:
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.