A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2

CompletadoFase 3ClinicalTrials.gov

ID: NCT03535194Tipo: INTERVENTIONALInicio: 26 de jun de 2018Fin estimado: 3 de jun de 2020

Traducción no disponible, mostrando original

Resumen

The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participant must have chronic plaque psoriasis for at least 6 months.

Criterios de exclusión

Participant must not be breastfeeding or nursing woman.
Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months.
Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.
Participant must not have any other skin conditions (excluding psoriasis).
Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz).
Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks.
Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).

Intervenciones

drug

Mirikizumab

Administered SC

drug

Placebo

Administered SC

drug

Secukinumab

Administered SC

Ubicaciones

CEDIC-Centro de Investigaciones Clinicas

Caba, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, Argentina

Instituto de Neumonología y Dermatología

Ciudad Autonoma Buenos Aires, Argentina

Psoriahue Medicina Interdisciplinaria

Ciudad Autonoma Buenos Aires, Argentina

Clinica Adventista de Belgrano

Ciudad Autonoma Buenos Aires, Argentina

Halitus Instituto Médico

Ciudad Autonoma de Buenos Aire, Argentina

Parra Dermatología

Mendoza, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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