NCT03996369

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Arena Pharmaceuticals · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-15
• Primary completion: 2021-12-07
• Completion: 2021-12-07
• First posted: 2019-06-24
• Last updated: 2022-12-21
• Results posted: 2022-12-21

Locations

407 sites across 41 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Lebanon, Lithuania, Mexico, Moldova, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study