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

Phase 2/3 Terminated NCT04173273

Condition	Crohn's Disease
Phase	Phase 2/3
Sponsor	Pfizer
Status	Terminated
Enrollment	379 participants
Interventions	Etrasimod, Etrasimod
Start date	Jan 6, 2020
Completion date	Apr 23, 2025
Results posted	Jul 1, 2026

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.

Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA

Week 14 of SSA · Percentage of participants

SSA: Placebo in Induction Period	NA Percentage of participants
SSA: Etrasimod 2 mg in Induction Period	21.4 Percentage of participants
SSA: Etrasimod 3 mg in Induction Period	12.2 Percentage of participants

Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1

Week 14 of SS1 · Percentage of participants

SS1: Placebo in Induction Period	14.9 Percentage of participants
SS1: Etrasimod 2 mg in Induction Period	17.3 Percentage of participants
SS1: Etrasimod 3 mg in Induction Period	14.9 Percentage of participants

p-value	=0.3147
Percentage Difference	2.5 (95% CI -6.1–11.1)

Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort

Week 52 of study · Percentage of participants

SS3 Responder Cohort: Placebo/Placebo	36.4 Percentage of participants
SS3 Responder Cohort: Etrasimod 2 mg/Etrasimod 2 mg	69.6 Percentage of participants
SS3 Responder Cohort: Etrasimod 2 mg/Placebo	50.0 Percentage of participants
SS3 Responder Cohort: Etrasimod 3 mg/Etrasimod 3 mg	87.5 Percentage of participants
SS3 Responder Cohort: Etrasimod 3 mg/Placebo	73.3 Percentage of participants

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Act — Janssen Research & Development, LLC
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severe — Janssen Research & Development, LLC
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn' — Janssen Research & Development, LLC
A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Partic — Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease — Celularity Incorporated
Loss of RESponse to Ustekinumab Treated by Dose Escalation — Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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