Resumen

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
Active UC confirmed by endoscopy

Criterios de exclusión

Severe extensive colitis
Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Intervenciones

drug

Etrasimod

Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period

drug

Placebo

Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period

Ubicaciones

Clinica Adventista Belgrano

CABA, Buenos Aires, Argentina

Mautalen Salud e Investigacion

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fundación Respirar- Centro Médico Dra. De Salvo

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Quilmes SRL

Quilmes, Buenos Aires, Argentina

CICE Sanatorio 9 de Julio

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalArena Pharmaceuticals

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis