Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

CompletadoFase 3ClinicalTrials.gov

ID: NCT02914522Tipo: INTERVENTIONALInicio: 14 de nov de 2016Fin estimado: 31 de mar de 2020

Traducción no disponible, mostrando original

Resumen

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
Moderately to severely active UC
Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab

Criterios de exclusión

Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
Active tuberculosis (TB) or history of latent TB that has not been treated
Use of any concomitant prohibited medications as described in the protocol

Intervenciones

drug

Filgotinib

Tablet(s) administered orally once daily

drug

PTM filgotinib

Tablet(s) administered orally once daily

Ubicaciones

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Argentina

Instituto Médico Cer

Quilmes, Argentina

Patrocinadores

PrincipalGilead Sciences

ColaboradorGalapagos NV

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