This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
Placebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3 and 4), then after four weeks at Week 8. At Week 12, PSSI responders will continue on placebo and receive their injections once weekly for five weeks (Weeks 12, 13, 14, 15 and 16), then followed by dosing after four weeks at Week 20. PSSI non-responders will be switched to receive 300 mg secukinumab at Weeks 12, 13, 14, 15 and 16, then after four weeks at Week 20. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
Aurora, Colorado, United States
Psoriasis Scalp Severity Index 90 (PSSI 90)
PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of "yes"
Time frame: 12 weeks
Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)
IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis
Time frame: 12 weeks
Change From Baseline in PSSI Score
Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe
Time frame: 12 weeks
Psoriasis Scalp Severity Index 75 (PSSI 75) Response
PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis
Time frame: 12 weeks
Psoriasis Scalp Severity Index 100 (PSSI 100) Response
PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis
Time frame: 12 weeks
Time to 50% Reduction in PSSI Score up to Week 12
Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm The median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo
Time frame: 12 weeks
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Novartis Investigative Site
Trumbull, Connecticut, United States
Novartis Investigative Site
Rockville, Maryland, United States
Novartis Investigative Site
Andover, Massachusetts, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Troy, Michigan, United States
Novartis Investigative Site
East Windsor, New Jersey, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
New York, New York, United States
...and 7 more locations
Psoriasis Area and Severity Index 75 (PASI 75)
PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis
Time frame: 12 weeks
Psoriasis Area and Severity Index 90 (PASI 90)
PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis
Time frame: 12 weeks
Psoriasis Area and Severity Index 100 (PASI 100)
PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis
Time frame: 12 weeks
Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)
IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis
Time frame: 12 weeks
Change From Baseline in Subject Assessment of Pain
Change from baseline in the Subject Assessment of Pain Scale of 0-10 with 10 being the most painful
Time frame: 12 weeks
Change From Baseline in Subject Assessment of Itching
Change from baseline in the Subject Assessment of Itching Scale of 0-10 with 10 being the most itchy
Time frame: 12 weeks
Change From Baseline in Subject Assessment of Scaling (Scalp Only)
Change from baseline in the Subject Assessment of Scaling (scalp only) Scale of 0-10 with 10 being the most scaling
Time frame: 12 weeks