NCT04682639

A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	Etrasimod	Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.
DRUG	Placebo	Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.
DRUG	Etrasimod	Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-09-30
• Completion: 2023-06-30
• First posted: 2020-12-24
• Last updated: 2024-05-06
• Results posted: 2023-10-26

Locations

256 sites across 8 countries: United States, Australia, Belgium, Canada, Germany, Netherlands, Spain, Switzerland

Regulatory

• FDA-regulated drug study