Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Plaque Psoriasis

In brief

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

Key facts

Study ID

NCT01358578

Run by

Novartis Pharmaceuticals

People needed

1306

Starts

2011-06-01

Expected to finish

2013-07-01

Last updated by the study team

2021-01-05

Who can join

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

You may qualify if…

• Subjects with chronic, plaque-type psoriasis for at least 6 months
• Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area
• Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)

You may not qualify if…

• Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)
• Drug induced psoriasis
• Use of other psoriasis treatments during the study
• Prior use of etanercept
• Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the IL-17 receptor
• Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment
• Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.
• History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
• Allergy to rubber or latex
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — High Point, North Carolina, United States
• Novartis Investigative Site — Warren, Ohio, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Johnston, Rhode Island, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Kingsport, Tennessee, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Norfolk, Virginia, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — CABA, Buenos Aires F.D., Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Mendoza, Argentina
• Novartis Investigative Site — Kogarah, 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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