Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year

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 secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.

Key facts

Study ID

NCT01365455

Run by

Novartis Pharmaceuticals

People needed

738

Starts

2011-06-01

Expected to finish

2013-04-01

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…

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
• Severity of psoriasis disease meeting all of the following three criteria:
• Psoriasis Area and Severity Index (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.
• Subjects not willing to limit UV light exposure during the study Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Oceanside, California, United States
• Novartis Investigative Site — Pasadena, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Snellville, Georgia, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — Oregon City, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• 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.