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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Scalp Psoriasis

Treatments: Biological: Secukinumab 300 mg; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267135

CAIN457AUS01

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

Secukinumab

Experimental group

Description:

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

Treatment:

Biological: Secukinumab 300 mg

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo