A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

CompletadoFase 3ClinicalTrials.gov

ID: NCT01365455Tipo: INTERVENTIONALInicio: 1 de jun de 2011Fin estimado: 1 de abr de 2013

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

secukinumab 150 mg

secukinumab (AIN457) 150mg or 300mg subcutaneous

drug

placebo to secukinumab 150 mg

Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Mendoza, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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