Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Plaque-type Psoriasis

In brief

This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.

Key facts

Study ID

NCT01406938

Run by

Novartis Pharmaceuticals

People needed

967

Starts

2011-08-01

Expected to finish

2013-05-01

Last updated by the study team

2015-05-19

Who can join

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

You may qualify if…

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
• Severity of disease meeting all of the following three criteria:
• PASI score of 12 or greater,
• Investigator's Global Assessment (IGA) score of 3 or greater
• Total body surface area (BSA) affected of 10% or greater.
• Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

You may not qualify if…

• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
• Hematological abnormalities.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
• Pregnant or nursing (lactating) women.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Pasadena, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Naples, Florida, United States
• Novartis Investigative Site — South Miami, Florida, United States
• Novartis Investigative Site — West Palm Beach, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Champaign, Illinois, United States
• Novartis Investigative Site — Skokie, Illinois, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Overland Park, Kansas, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Fridley, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Henderson, Nevada, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — Verona, New Jersey, United States
• Novartis Investigative Site — Greensboro, North Carolina, United States
• Novartis Investigative Site — High Point, North Carolina, United States
• Novartis Investigative Site — Fresno, California, United States

Full record on ClinicalTrials.gov

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