Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Palmoplantar Psoriasis

In brief

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.

Key facts

Study ID

NCT01806597

Run by

Novartis Pharmaceuticals

People needed

205

Starts

2013-06-19

Expected to finish

2016-11-02

Last updated by the study team

2018-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Verona, New Jersey, United States
• Novartis Investigative Site — High Point, North Carolina, United States
• Novartis Investigative Site — Goodlettsville, Tennessee, United States
• Novartis Investigative Site — Sydney, New South Wales, Australia
• Novartis Investigative Site — Woolloongabba, Queensland, Australia
• Novartis Investigative Site — Carlton, Victoria, Australia
• Novartis Investigative Site — East Melbourne, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Calgary, Alberta, Canada
• Novartis Investigative Site — Barrie, Ontario, Canada
• Novartis Investigative Site — London, Ontario, Canada
• Novartis Investigative Site — Waterloo, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Helsinki, Finland
• Novartis Investigative Site — Tampere, Finland
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Miskolc, Hungary
• Novartis Investigative Site — Szeged, Hungary
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.