Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab 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 disease meeting all of the following three criteria:

• 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.

• Other protocol-defined inclusion/exclusion criteria may apply.