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

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Nail Psoriasis

In brief

This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.

Key facts

Study ID

NCT01807520

Run by

Novartis Pharmaceuticals

People needed

198

Starts

2013-06-20

Expected to finish

2017-01-03

Last updated by the study team

2018-03-13

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, including significant nail involvement, defined as Nail Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score ≥10%
• 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 inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects
• 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
• Exposure to 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
• History of hypersensitivity to constituents of the study treatment
• Other protocol-defined inclusion/exclusion criteria do apply

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Skokie, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — High Point, North Carolina, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Sydney, New South Wales, Australia
• Novartis Investigative Site — Woolloongabba, Queensland, Australia
• Novartis Investigative Site — East Melbourne, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Ústí nad Labem, Czech Republic, Czechia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Arhus C, Denmark
• Novartis Investigative Site — Copenhagen NV, Denmark
• Novartis Investigative Site — Hellerup, Denmark
• Novartis Investigative Site — Bad Bentheim, Germany
• Novartis Investigative Site — Bielefeld, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Kiel, Germany
• Novartis Investigative Site — Münster, Germany
• Novartis Investigative Site — Heraklion, Crete, GR, Greece

Full record on ClinicalTrials.gov

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