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NCT04173273 · ClinicalTrials.gov registry record · Phase 2

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 Phase 2 study, sponsored by Pfizer.

Terminated
Registry status
Phase 2
Development phase
379
Enrollment target

NCT04173273: Clinical Trial Phase 2 study, sponsored by Pfizer.

NCT04173273 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 379 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04173273, a Phase 2 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 2
Development phase
379 participants
Enrollment target

Study 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.

Primary Outcome

Endoscopic response: SES-CD score \<=4 and at least 2-point reduction from baseline with no subscore \>1 or \>=50% decrease from study baseline in SES-CD. SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers. Ulcerated surface score: 0= none,

Interventions

  • DRUG Placebo
  • DRUG Etrasimod

Trial Details

FieldValue
Enrollment Target 379 participants
Start Date 2020-01-06
Est. Completion 2025-06-09
Phase Phase 2
Pfizer

1,845 total trials

Why NCT04173273 stopped before completion

NCT04173273 is an interventional study that assigns participants to a tested intervention. The registered 379 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (185% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04173273 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04173273 about?

NCT04173273 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease". 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 ...

What is the current status of trial NCT04173273?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 379 participants. The study started on 2020-01-06. Estimated completion is 2025-06-09.

What interventions are being tested in trial NCT04173273?

The interventions under investigation include: Placebo (DRUG), Etrasimod (DRUG).

Who is sponsoring clinical trial NCT04173273?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04173273's enrollment target sits among peer trials

379 115th of 2000 higher than 1,886 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04173273, the US trial registry maintained by the National Library of Medicine. NCT04173273 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.