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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time frame: week 13
Percentage of Participants With Investigator's Global Assessment (IGA) Response
IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
Time frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
To Assess the Time to Relapse
Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.
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Novartis Investigative Site
Rochester, New York, United States
Novartis Investigative Site
Lake Oswego, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Novartis Investigative Site
North Bay, Ontario, Canada
Novartis Investigative Site
Waterloo, Ontario, Canada
Novartis Investigative Site
Tallinn, Estonia, Estonia
Novartis Investigative Site
Tallinn, Estonia
...and 9 more locations
Time frame: 37 weeks