NCT04173273

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

A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

Detailed description

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Etrasimod	Dose A taken by mouth, once daily.
DRUG	Etrasimod	Dose B taken by mouth, once daily.
DRUG	Placebo	Etrasimod matching placebo tablet taken by mouth, once daily.

Timeline

• Start date: 2020-01-06
• Primary completion: 2025-04-23
• Completion: 2025-06-09
• First posted: 2019-11-21
• Last updated: 2025-07-16

Locations

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

Regulatory

• FDA-regulated drug study