Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

Completed · Phase 3

Conditions studied: Plaque-type Psoriasis

In brief

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

Key facts

Study ID

NCT01412944

Run by

Novartis Pharmaceuticals

People needed

43

Starts

2011-12-01

Expected to finish

2013-04-01

Last updated by the study team

2015-03-18

Who can join

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

You may qualify if…

• Written Informed Consent must be obtained before any assessment is performed,
• Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
• Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
• A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

You may not qualify if…

• Pregnant women or lactating women
• Forms of psoriasis other than chronic plaque -type
• Ongoing use of prohibited psoriasis treatments
• Ongoing use of other non-psoriasis prohibited treatments
• Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
• Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
• UV therapy or excessive exposure to sunlight

Where it is running

• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — West Palm Beach, Florida, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Greensboro, North Carolina, United States
• Novartis Investigative Site — Greer, South Carolina, United States
• Novartis Investigative Site — Wels, Austria, Austria
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Barrie, Ontario, Canada
• Novartis Investigative Site — Waterloo, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Toulouse, France, France
• Novartis Investigative Site — Rouen, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Lübeck, Germany
• Novartis Investigative Site — Mainz, Germany
• Novartis Investigative Site — Mangalore, Karnataka, India
• Novartis Investigative Site — Nagpur, Maharashtra, India
• Novartis Investigative Site — Nashik, Maharashtra, India
• Novartis Investigative Site — Kisarazu, Chiba, Japan
• Novartis Investigative Site — Hachiōji, Tokyo, Japan
• Novartis Investigative Site — Minato-ku, Tokyo, Japan

Full record on ClinicalTrials.gov

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