Phase 3
N=102
Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis
Chronic Scalp Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02267135 ↗Enrolled (actual)
102
Serious AEs
1.2%
Results posted
Feb 2018
Primary outcome: Primary: Psoriasis Scalp Severity Index 90 (PSSI 90) — 52.9; 2.0 Percent of Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab 300 mg (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psoriasis Scalp Severity Index 90 (PSSI 90) |
52.9; 2.0 | <0.001 sig |
| SECONDARY Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only) |
56.9; 5.9 | — |
| SECONDARY Change From Baseline in PSSI Score |
-25.47; -5.98 | — |
| SECONDARY Psoriasis Scalp Severity Index 75 (PSSI 75) Response |
62.7; 5.9 | — |
| SECONDARY Psoriasis Scalp Severity Index 100 (PSSI 100) Response |
35.3; 0.0 | — |
| SECONDARY Time to 50% Reduction in PSSI Score up to Week 12 |
3.29 | — |
| SECONDARY Psoriasis Area and Severity Index 75 (PASI 75) |
64.7; 2.0 | — |
| SECONDARY Psoriasis Area and Severity Index 90 (PASI 90) |
47.1; 0.0 | — |
| SECONDARY Psoriasis Area and Severity Index 100 (PASI 100) |
23.5; 0.0 | — |
| SECONDARY Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp) |
52.9; 3.9 | — |
| SECONDARY Change From Baseline in Subject Assessment of Pain |
-1.43; 1.04 | — |
| SECONDARY Change From Baseline in Subject Assessment of Itching |
-4.10; -0.24 | — |
| SECONDARY Change From Baseline in Subject Assessment of Scaling (Scalp Only) |
-5.24; -0.65 | — |
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
Data sourced from ClinicalTrials.gov (NCT02267135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.