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