NCT03945188

Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: Arena Pharmaceuticals · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Etrasimod	Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
DRUG	Placebo	Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

Timeline

• Start date: 2019-06-13
• Primary completion: 2022-02-08
• Completion: 2022-02-16
• First posted: 2019-05-10
• Last updated: 2022-12-20
• Results posted: 2022-12-20

Locations

315 sites across 40 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Latvia, Lebanon, Lithuania, Mexico, Moldova, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study