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Evaluating oral etrasimod for treating active Crohn's disease in adults

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

Phase 3 Interventional Pfizer · NCT04173273

This study is testing a new oral medication called etrasimod to see if it can help adults with active Crohn's disease who haven't found relief from other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1175 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsinfliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, radiation, methotrexate, prednisone
Locations519 sites (Dothan, Alabama and 518 other locations)
Trial IDNCT04173273 on ClinicalTrials.gov

What this trial studies

This Phase 3 study assesses the efficacy, safety, and tolerability of oral etrasimod in adults with moderately to severely active Crohn's disease who have not responded to or are intolerant to existing therapies. It consists of five substudies, including randomized, double-blind, placebo-controlled phases to determine the best induction and maintenance doses. The overall study duration is up to 282 weeks, including treatment and follow-up periods. Participants will be monitored for safety and efficacy throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with moderately to severely active Crohn's disease who have previously failed or are intolerant to at least one existing treatment.

Not a fit: Patients with mild Crohn's disease or those who have not tried any prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with Crohn's disease who have not benefited from current therapies.

How similar studies have performed: Other studies evaluating similar therapies for Crohn's disease have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Eligibility criteria applicable to all substudies:

Inclusion Criteria:

* Men or women 18 to 80 years of age,
* Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
* Diagnosed with Crohn's disease (CD) ≥ 3 months
* Have moderately to severely active CD at Screening
* Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD:

  1. Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
  2. Immunosuppressants (eg, azathioprine \[AZA\], 6 mercaptopurine \[6-MP\], or methotrexate \[MTX\])
  3. Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
  4. Integrin receptor antagonist (eg, vedolizumab)
  5. Interleukin -12/-23 antagonist (eg, ustekinumab)
* Females of childbearing potential must be nonpregnant
* Females of childbearing potential and males must use contraception

Exclusion Criteria:

* History of inadequate response (ie, primary non-response) to agents from ≥ 2 classes of biologics marketed for the treatment of CD (ie, TNFα antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
* Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening.
* Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
* Had surgical treatment for intra abdominal abscesses ≤ 8 weeks prior to randomization or surgical treatment for perianal abscesses ≤ 4 weeks prior to randomization.
* Had intestinal resection ≤ 24 weeks prior to randomization or other intra abdominal surgeries ≤ 12 weeks prior to randomization.
* Have an ileostomy or a colostomy.

Inclusion Criteria for Substudy 3:

- Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit

Inclusion Criteria for Substudy 4:

- Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A

Where this trial is running

Dothan, Alabama and 518 other locations

+469 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseEtrasimodCrohn's diseaseAPD334Inflammatory bowel disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.