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New study checks if etrasimod tames ulcerative colitis symptoms in daily life

NCT ID NCT06294925

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This study looks at how well etrasimod works for people with moderate to severe ulcerative colitis when used in normal doctor visits. About 360 adults aged 18 to 65 will take etrasimod as prescribed by their doctor and fill out health questionnaires online. Researchers will track symptom remission and other outcomes over 52 weeks to see if the drug helps control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
etrasimod
What this could lead to
If successful, this study could show that etrasimod helps people with ulcerative colitis achieve symptom remission and better quality of life in everyday medical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also relatively small (360 people) and only follows patients for one year.

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 360 people

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

Started

May 2024

Expected to finish

May 2027

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 local approved label 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: * Male and female patients ≥18 and \<65 years of age at baseline * Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study. * Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. Exclusion Criteria: * Presence of clinical findings suggestive of Crohn's disease. * 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 (eg, 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) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator. * Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool. * 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

Contacts and locations

Locations

  • Barts Health NHS Trust, The Royal London Hospital

    London, E1 1BB, United Kingdom

  • CED am Rhein

    Wesseling, 50389, Germany

  • CHUM

    Montreal, Quebec, H2X 3E4, Canada

  • Columbia Medical Building

    New Westminster, British Columbia, V3L 3E3, Canada

  • Evangelisches Krankenhaus Kalk

    Cologne, 51103, Germany

  • Facharztpraxis für Gastroenterologie

    Grevenbroich, 41515, Germany

  • Gastroenterologie OpernstraBe

    Kassel, Hesse, 34117, Germany

  • Gastrofreiburg

    Freiburg im Breisgau, Breisgau, 79102, Germany

  • Hôpital du Sacré-Cœur de Montréal

    Montreal, Quebec, H4J 1C4, Canada

  • Imperial College Healthcare NHS

    London, W2 1PG, United Kingdom

  • Interdisziplinares Crohn Colitis Centrum

    Frankfurt am Main, 60594, Germany

  • Internistische Praxengemeinschaft Oldenburg

    Oldenburg, 10115, Germany

  • Kelowna Gastroenterology Associates

    Kelowna, British Columbia, V1Y 6J6, Canada

  • Kings College Hospital

    London, SE59RS, United Kingdom

  • Klinikum Lüneburg

    Lüneburg, 21339, Germany

  • London Health Sciences Centre

    London, Ontario, N6A5A5, Canada

  • MVZ Dachau

    Dachau, 85221, Germany

  • MVZ Gastroenterologie Aachen

    Aachen, 52064, Germany

  • MVZ für Gastroenterologie am Bayerischen Platz

    Berlin, 10825, Germany

  • Magen-Darm-Zentrum Remscheid

    Remscheid, 42859, Germany

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4, Canada

  • NHS Greater Glasgow and Clyde

    Glasgow, Lanarkshire, G4 0SF, United Kingdom

  • Northern Care Alliance NHS Foundation Trust, Greater Manchester

    Crumpsall, M8 5RB, United Kingdom

  • Nottingham University Hospitals NHS Trust, Queens Medical Centre

    Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

  • Ottawa Hospital

    Ottawa, Ontario, K1H8L6, Canada

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Praxis Heil und Müller

    Andernach, 56626, Germany

  • Praxis für Gasteroenterologie

    Heidelberg, 69115, Germany

  • Praxis für Gasteroenterologie Lübeck

    Lübeck, 23560, Germany

  • Providence Health Care (PHC)

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Richmond Hospital

    Richmond, British Columbia, V7C 5L9, Canada

  • Royal Gwent Hospital

    Newport, NP20 2UB, United Kingdom

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD, United Kingdom

  • St George's Hospital - St George's Healthcare Nhs Trust

    London, SW17 0QT, United Kingdom

  • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH, United Kingdom

  • St. Mark's Hospital

    London, HA1 3UJ, United Kingdom

  • Studiengesellschaft BSF UG.

    Halle, 06108, Germany

  • Tunbridge Wells Hospital

    Kent, TN2 4QJ, United Kingdom

  • University College London Hospital

    London, NW1 2PG, United Kingdom

  • Vancouver Coastal Health

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU, United Kingdom

More trials for these conditions

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