Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Efficacy of Subcutaneous Secukinumab [300 mg] as Assessed by the Psoriasis Scalp Severity Index (PSSI) at 12 Weeks of Treatment, Compared to Placebo, and to Assess Safety and Tolerability up to 24 Weeks in Adult Subjects With Moderate to Severe Scalp Psoriasis

Conditions
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Chronic Scalp Psoriasis

Intervention / Treatment
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* Biological: Secukinumab 300 mg
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic scalp psoriasis for at least the previous six months Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy. Exclusion Criteria: Forms of psoriasis other than chronic plaque Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors) Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy) Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors Use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer Active, ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab<br>Eligible patients will receive secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 20 inclusive | Biological: Secukinumab 300 mg<br>* 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.<br>* Other names: AIN457 300 mg;|
| Placebo Comparator: Placebo<br>Eligible patients will receive placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8. Prior to taking the Week 12 dose, the patient will be assessed for response to treatment using the Psoriasis Scalp Severity Index (PSSI). If the subject is a responder, the subject will continue on placebo dosing weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. Subjects who are not responders will be switched to treatment with secukinumab 300 mg and will dose once weekly at Weeks 12, 13, 14, 15 and 16 and then after four weeks at Week 20. | Biological: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 12 weeks | 
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A