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