Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,114
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12
Number of participants who achieved ≥ 90% reduction in PASI compared to baseline. Logistic regression analysis of PASI 90 response at Week 12 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, upper limbs, trunk, lower limbs; 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 body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).
Time frame: Week 12
Participants With IGA Mod 2011 0 or 1 at Week 12
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
Time frame: Week 12
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.
Time frame: Week 12
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4
Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.
Time frame: Week 4
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16
Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.
Time frame: Week 16
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Novartis Investigative Site
Anniston, Alabama, United States
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Mobile, Alabama, United States
Novartis Investigative Site
Glendale, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Scottsdale, Arizona, United States
Novartis Investigative Site
Scottsdale, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
...and 144 more locations
Participants With IGA Mod 2011 0 or 1 at 16 Weeks
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
Time frame: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12
Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.
Time frame: Week 12
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.
Time frame: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.
Time frame: Week 16
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52
Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.
Time frame: Week 52