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New pill hopes to tame severe gut disease in kids

NCT ID NCT07470879

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 2 times

Summary

This study tests a daily pill called etrasimod in 24 children aged 2 to 12 with moderate to severe ulcerative colitis, a chronic inflammatory bowel disease. The goal is to see if the drug can safely help children reach remission (few or no symptoms) over 52 weeks. Participants who finish may continue treatment for up to 5 years.

What this could mean

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

Active substance
Etrasimod (a daily pill that helps control inflammation in the gut)
What this could lead to
If successful, this could provide a new treatment option for children with ulcerative colitis, helping them achieve and maintain remission.
What could go wrong
This is a small, early-phase study with only 24 children, so results may not apply to all patients. The drug may cause side effects or fail to show clear benefit.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

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

Started

May 2026

Expected to finish

Aug 2034

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.

Ages

2 to 11 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: Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active Participants are permitted to be receiving a therapeutic dose of select UC therapies Exclusion criteria: Severe extensive colitis Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

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Conditions

The condition(s) this trial relates to.

colitis ulcer disease 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

    42 sites in 10 countries. 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

  • Alder Hey Children's Hospital

    RECRUITING

    Liverpool, L14 5AB, United Kingdom

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    NOT_YET_RECRUITING

    Florence, Tuscany, 50139, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    RECRUITING

    Bergamo, Lombardy, 24127, Italy

  • Bristol Royal Hospital for Children

    NOT_YET_RECRUITING

    Bristol, BS2 8BJ, United Kingdom

  • CHU de Québec - Université Laval

    RECRUITING

    Québec, Quebec, G1V4G2, Canada

  • Carmel Medical Center

    RECRUITING

    Haifa, Northern District, 3436212, Israel

  • Centrum Zdrowia MDM

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-189, Poland

  • Children's Hospital Research Institute of Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 3P4, Canada

  • Evelina London Children's Hospital

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Fink Children's Ambulatory Care Center

    RECRUITING

    New York, New York, 10016, United States

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    NOT_YET_RECRUITING

    Milan, Lombardy, 20122, Italy

  • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

    RECRUITING

    Katowice, 40-600, Poland

  • HELIOS Klinikum Wuppertal

    RECRUITING

    Wuppertal, 42283, Germany

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, Jerusalem, 9112001, Israel

  • Health Sciences Centre Winnipeg

    RECRUITING

    Winnipeg, Manitoba, R3A 1S1, Canada

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    RECRUITING

    Bron, Auvergne-Rhône-Alpes, 69500, France

  • Hôpital Universitaire Necker Enfants Malades

    RECRUITING

    Paris, 75015, France

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    RECRUITING

    Warsaw, 04-730, Poland

  • Japanese Red Cross Kumamoto Hospital

    RECRUITING

    Kumamoto, 861-8520, Japan

  • Juntendo University Hospital

    RECRUITING

    Tokyo, 113-8431, Japan

  • Kaplan Medical Center

    RECRUITING

    Rehovot, Central District, 7610001, Israel

  • Kaplan Medical Center Pharmacy

    RECRUITING

    Rehovot, Central District, 7610001, Israel

  • Kimmel Pavilion - NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • King's College Hospital

    RECRUITING

    London, London, CITY of, SE5 9RL, United Kingdom

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-501, Poland

  • Monash Health

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • NYU Grossman School of Medicine

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Health (Tisch Hospital)

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Inflammatory Bowel Disease Center

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Radiology - Tisch Hospital

    RECRUITING

    New York, New York, 10016, United States

  • NYU Medical Science Building (MSB)

    RECRUITING

    New York, New York, 10016, United States

  • Perth Children's Hospital

    NOT_YET_RECRUITING

    Perth, Western Australia, 6009, Australia

  • Rambam Health Care Campus

    RECRUITING

    Haifa, Northern District, 3109601, Israel

  • Saitama Prefectural Children's Medical Center

    RECRUITING

    Saitama-shi, Saitama, 330-8777, Japan

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, Jerusalem, 9013102, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5262100, Israel

  • Sheffield Children's Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • The Children's Hospital at Westmead

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Universitaetsklinikum Tuebingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Yitzhak Shamir Medical Center

    RECRUITING

    Ẕerifin, Central District, 70300, Israel

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