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Real-World study tests ulcerative colitis drug etrasimod

NCT ID NCT06398626

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study watches 300 adults with moderate to severe ulcerative colitis who are prescribed etrasimod by their doctor. Researchers track symptoms like stool frequency and rectal bleeding over 52 weeks using health questionnaires. The goal is to see how well the drug works outside of a controlled clinical setting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the United States etrasimod prescribing information and independent from the decision to enroll the patient in this study.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years and \< 65 years at baseline 2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC 3. Evidence of a personally signed and dated ICD indicating that the patient (or a legally acceptable representative)has been informed of all pertinent aspects of the study Exclusion Criteria: 1. The presence of clinical findings suggestive of Crohn's disease 2. Severe extensive colitis evidenced by: 1. Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks 2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization 4. Prior/Concomitant Therapy: 1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program 2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine) 3. Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \[filgotinib, tofacitinib, or upadacitinib\]) or with any other S1P receptor modulator 5. Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool 6. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BI Research Center

    RECRUITING

    Houston, Texas, 77084, United States

  • Brooke Army Medical center

    RECRUITING

    San Antonio, Texas, 78234, United States

  • Brooke Army Medical center

    NOT_YET_RECRUITING

    San Antonio, Texas, 78234, United States

  • Digestive and Liver Center of Florida Kissimmee

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Feinberg School of Medicine Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • GI Alliance Research

    RECRUITING

    Southlake, Texas, 76092, United States

  • Gastro Florida

    TERMINATED

    Lutz, Florida, 33558, United States

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    RECRUITING

    Westlake, Ohio, 44145, United States

  • Houston Endoscopy & Research Center

    RECRUITING

    Houston, Texas, 77079, United States

  • Lenox Hill Hospital, Northwell Health

    RECRUITING

    New York, New York, 10075, United States

  • MGG Group Co., Inc., Chevy Chase Clinical Research

    RECRUITING

    Chevy Chase, Maryland, 20815, United States

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • OnSite Clinical Solutions, LLC

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Orlando Health/Digestive Health Institute

    NOT_YET_RECRUITING

    Orlando, Florida, 32806, United States

  • Reddy GI Associates

    RECRUITING

    Mesa, Arizona, 85206, United States

  • Rocky Mountain Gastroenterology

    RECRUITING

    Littleton, Colorado, 80120, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Scripps Clinic Torrey Pines

    RECRUITING

    La Jolla, California, 92037, United States

  • Suburban Gastroenterology Ltd

    RECRUITING

    Naperville, Illinois, 60540, United States

  • United Medical Doctors

    RECRUITING

    Los Alamitos, California, 90720, United States

  • United Medical Doctors

    NOT_YET_RECRUITING

    Los Alamitos, California, 90720, United States

  • University of Cincinnati College of Medicine

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Virtua Health

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • WVU Medicine J.W Ruby Memorial Hospital

    RECRUITING

    Morgantown, West Virginia, 26505, United States

  • Washington Gastroenterology

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Woodholme Gastroenterology Associates PA

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

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Other studies related to the condition(s) this trial covers.