Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis
Condition: Chronic Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab 300 mg; Placebo
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: scalp psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, psoriasis, AIN457A

Summary:

      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.
    

Eligibility criteria:

        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