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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.