Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis

CompletadoFase 3ClinicalTrials.gov

ID: NCT03073200Tipo: INTERVENTIONALInicio: 28 de mar de 2017Fin estimado: 23 de mar de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.
Have Psoriasis Area and Severity Index (PASI) score ≥12 and a Static Physician Global Assessment (sPGA) ≥3 and body surface area involvement ≥10% at screening and baseline.
Are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies.
Male subjects agree to use a reliable method of birth control during the study.
Female subjects: Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counselled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug, or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.
Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.
All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific paediatric authorities (e.g., the American Academy of Paediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.

Criterios de exclusión

Have pustular, erythrodermic, and/or guttate forms of psoriasis.
Have drug-induced psoriasis.
Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).
Participants with a documented history of immune deficiency syndrome.
Have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline.
Subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly unless ruled out by biopsy.
Have used any therapeutic agent targeted at reducing interleukin-17.
Have received other therapies within the specified time frames prior to screening (see below):
adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives.
systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy \[psoralen plus ultraviolet A\]) in the previous 4 weeks.

Intervenciones

drug

Ixekizumab

Administered SC

drug

Placebo

Administered SC

drug

Etanercept

Administered SC

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Fundación Estudios Clínicos- Servicio de Dermatología

Rosario, Santa Fe Province, Argentina

Instituto de Neumonología y Dermatología

Buenos Aires, Argentina

Psoriahue Medicina Interdisciplinaria

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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