Status:
COMPLETED
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Moderate to Severe Palmoplantar Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- 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
- 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
Key Trial Info
Start Date :
June 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2016
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT01806597
Start Date
June 19 2013
End Date
November 2 2016
Last Update
February 22 2018
Active Locations (54)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35205
2
Novartis Investigative Site
Phoenix, Arizona, United States, 85032
3
Novartis Investigative Site
Indianapolis, Indiana, United States, 46256
4
Novartis Investigative Site
Louisville, Kentucky, United States, 40291