This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
secukinumab
placebo comparator
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Pasadena, California, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
East Windsor, New Jersey, United States
Novartis Investigative Site
Verona, New Jersey, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Rochester, New York, United States
Novartis Investigative Site
High Point, North Carolina, United States
Novartis Investigative Site
Dallas, Texas, United States
...and 2 more locations
Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12
Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Time frame: Baseline, Week 12
Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52
Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Time frame: Week 52
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