Last updated 2 months ago

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

1175 patients around the world
Available in Chile, United States, Colombia, Argentina, Puerto Rico, Mexico, Spain
This study includes 5 substudies: Substudy A - Phase 2: A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in participants with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3. Substudy 1 - Phase 2: A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3. Substudy 2 - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy. Substudy 3 - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy. Participants from Substudy 1 and Substudy 2 will be enrolled in Substudy 3. Substudy 4 - Long-Term Extension: A long-term extension substudy for participants who complete at least 52 weeks of treatment. Participants from Substudy 3 and Substudy A are planned to be enrolled in Substudy 4.
Arena Pharmaceuticals
51Research sites
1175Patients around the world

This study is for people with

Crohn's disease
Moderate to severe crohn's disease

Requirements for the patient

To 80 Years
All Gender

Medical requirements

Sites

CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Av. Galvan 4102, CABA, Buenos Aires
Clínica Adventista Belgrano - CABA - Buenos Aires
Clínica Adventista Belgrano - CABA - Buenos Aires
Estomba 1710, CABA, Buenos Aires
I.M.E.P. Instituto Médico Elsa Pérez
I.M.E.P. Instituto Médico Elsa Pérez
Av Republica 1095, Ciudadela, Buenos Aires
Microcirugía Ocular S.A.
Recruiting
Corrientes 335, Rosario, Santa Fe
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Italia 428, Rosario - Santa Fe
Centro de Investigaciones Médicas Tucumán
Recruiting
Lavalle 506, T4000 San Miguel de Tucumán, Tucumán, Argentina
GR Gastroenterología Rosario
Recruiting
Sta Fe 1831 3er piso, S2000 Rosario, Santa Fe
Clinica Pueyrredon
Jujuy 2176, Mar del Plata, Buenos Aires
Cen Asma Centro de Enfermedades Respiratorias
C. 15 1243, B1900 DXM, Provincia de Buenos Aires
Estudio De La Vision
Dr. Delfor Díaz 1949, Hurlingham, Provincia de Buenos Aires
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