A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis

CompletadoFase 3ClinicalTrials.gov

ID: NCT02513550Tipo: INTERVENTIONALInicio: 1 de ago de 2015Fin estimado: 3 de ago de 2017

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

Descripción detallada

The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Present with chronic plaque psoriasis for at least 6 months prior to enrollment
At least 10% BSA of psoriasis at screening and at enrollment
sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
Candidates for phototherapy and/or systemic therapy
Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Criterios de exclusión

Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
History of drug-induced psoriasis
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
Concurrent or recent use of any biologic agent
Have participated in any study with ixekizumab
Received a live vaccination within 12 weeks prior to enrollment
Serious disorder or illness other than psoriasis
Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
Major surgery within 8 weeks of baseline, or will require surgery during the study
Breastfeeding or nursing (lactating) women

Intervenciones

drug

Ixekizumab

Administered SQ

drug

Placebo

Administered SQ

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mendoza, Argentina

Patrocinadores

PrincipalEli Lilly and Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Multicenter, Randomized, Double-Blind Study Comparing t... | EligiMed