The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in 24 subjects with moderate to severe plaque-type psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
214
2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment
Number of participants who achieved ≥ 75% reduction in PASI compared to baseline 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: 12 weeks
Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment
The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Time frame: 12 weeks
Participants With PASI 90 After 12 Weeks of Treatment
Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline
Time frame: 12 weeks
Number of Participants With PASI 100 Response After 12 Weeks of Treatment
Participants who achieved 100% reduction in PASI compared to baseline
Time frame: 12 weeks
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
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Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Fountain Valley, California, United States
Novartis Investigative Site
Fremont, California, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Marietta, Georgia, United States
Novartis Investigative Site
Savannah, Georgia, United States
Novartis Investigative Site
Saint Joseph, Missouri, United States
Novartis Investigative Site
Verona, New Jersey, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
...and 42 more locations
PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Time frame: up to week 52