First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Plaque-type Psoriasis

In brief

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Key facts

Study ID

NCT01555125

Run by

Novartis Pharmaceuticals

People needed

177

Starts

2012-05-08

Expected to finish

2016-10-24

Last updated by the study team

2018-08-08

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. Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Glendale, Arizona, United States
• Novartis Investigative Site — Hot Springs, Arkansas, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Newnan, Georgia, United States
• Novartis Investigative Site — Skokie, Illinois, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Fridley, Minnesota, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Lake Oswego, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Goodlettsville, Tennessee, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — Bryan, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Hamilton, Ontario, Canada
• Novartis Investigative Site — North Bay, Ontario, Canada
• Novartis Investigative Site — Waterloo, Ontario, Canada
• Novartis Investigative Site — Québec, Canada
• Novartis Investigative Site — Tallinn, Estonia
• Novartis Investigative Site — Tartu, Estonia
• Novartis Investigative Site — Martigues, France

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.