Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis
- Conditions
- Chronic Scalp Psoriasis
- Interventions
- Biological: Secukinumab 300 mgBiological: Placebo
- Registration Number
- NCT02267135
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Secukinumab Secukinumab 300 mg 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 Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method Psoriasis Scalp Severity Index 90 (PSSI 90) 12 weeks 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"
- Secondary Outcome Measures
Name Time Method Psoriasis Scalp Severity Index 75 (PSSI 75) Response 12 weeks PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis
Psoriasis Scalp Severity Index 100 (PSSI 100) Response 12 weeks PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis
Psoriasis Area and Severity Index 90 (PASI 90) 12 weeks PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis
Psoriasis Area and Severity Index 100 (PASI 100) 12 weeks PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis
Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp) 12 weeks 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
Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only) 12 weeks 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
Change From Baseline in PSSI Score 12 weeks Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe
Time to 50% Reduction in PSSI Score up to Week 12 12 weeks 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 placeboChange From Baseline in Subject Assessment of Pain 12 weeks Change from baseline in the Subject Assessment of Pain
Scale of 0-10 with 10 being the most painfulPsoriasis Area and Severity Index 75 (PASI 75) 12 weeks PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis
Change From Baseline in Subject Assessment of Itching 12 weeks Change from baseline in the Subject Assessment of Itching
Scale of 0-10 with 10 being the most itchyChange From Baseline in Subject Assessment of Scaling (Scalp Only) 12 weeks Change from baseline in the Subject Assessment of Scaling (scalp only)
Scale of 0-10 with 10 being the most scaling
Trial Locations
- Locations (1)
Novartis Investigative Site
🇺🇸West Jordan, Utah, United States