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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Novartis Investigative Site
Santa Monica, California, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
High Point, North Carolina, United States
Novartis Investigative Site
Duncansville, Pennsylvania, United States
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time frame: baseline, week 4
Change From Baseline in PASI
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time frame: baseline, weeks 12, 14, 16, 20, 24, 28 and 32
Investigator Global Assessment (IGA) Scores
This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.
Time frame: baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32
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Novartis Investigative Site
Nashville, Tennessee, United States