Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept 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; Etanercept

Criteria

Inclusion Criteria:

• Subjects with chronic, plaque-type psoriasis for at least 6 months

• Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area

• Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)

Exclusion Criteria:

• Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)

• Drug induced psoriasis

• Use of other psoriasis treatments during the study

• Prior use of etanercept

• Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the IL-17 receptor

• Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment

• Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.

• History of an ongoing, chronic or recurrent infection or evidence of tuberculosis

• Allergy to rubber or latex

Other protocol-defined inclusion/exclusion criteria may apply