Estudio de extensión a largo plazo para evaluar la seguridad de filgotinib en sujetos con colitis ulcerosa

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT02914535Tipo: INTERVENTIONALInicio: 23 de feb de 2017Fin estimado: 1 de sept de 2026

Resumen

El objetivo primario de este estudio es observar la seguridad a largo plazo de filgotinib en adultos que hayan completado o cumplido los criterios de discontinuación por eficacia especificados en el protocolo en un estudio de tratamiento previo con filgotinib en colitis ulcerosa (CU).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC
Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC
Females of childbearing potential must have a negative pregnancy test at Day 1
Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described
Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug

Criterios de exclusión

Known hypersensitivity to the study drug
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
Use of prohibited medications as outlined in the protocol

Intervenciones

drug

Filgotinib

Tablet(s) administered orally once daily

drug

Placebo

Tablet(s) administered orally once daily

Ubicaciones

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Argentina

Instituto Médico Cer

Quilmes, Argentina

Patrocinadores

PrincipalAlfasigma S.p.A.

ColaboradorGilead Sciences

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.

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