Phase 3
N=205
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
Moderate to Severe Palmoplantar Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01806597 ↗Enrolled (actual)
205
Serious AEs
14.2%
Results posted
Feb 2018
Primary outcome: Primary: Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment — 22; 33.3; 1.5 Percentages of participants — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- secukinumab 150 mg (Biological); secukinumab 300 mg (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment |
22; 33.3; 1.5 | 0.0002 sig |
| SECONDARY Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I |
1.5; 1.4; 0; 1.5; 7.2; 0 | — |
| SECONDARY Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II |
22.1; 33.3; 0.0; 0.0; 100.0; 32.4 | — |
| SECONDARY Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period |
23.4; 37.7; 0.0; 0.0; 25.0; 40.7 | — |
| SECONDARY Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I |
-1.13; -2.22; -0.85; -3.11; -5.32; -1.90 | — |
| SECONDARY Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set |
-8.97; -12.67; -1.57; -3.11; -7.15; -16.29 | — |
| SECONDARY Number of Participants Developing Anti-secukinumab Antibodies |
2; 2; 2; 3 | — |
Summary
Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.
Eligibility Criteria
Inclusion Criteria
- Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months prior to randomization and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area
- Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy
Exclusion Criteria
- Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
- Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
- Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply.
- Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
- Use of any investigational drugs within 4 weeks prior to study treatment initiation 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 therapy
- History of hypersensitivity to constituents of the study treatment
Data sourced from ClinicalTrials.gov (NCT01806597). 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.