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New pill hopes to tame teen colitis

NCT ID NCT05287126

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study tests a daily medication called etrasimod in 36 adolescents aged 12 to 17 with moderate-to-severe ulcerative colitis. The goal is to see if the drug can safely help control the disease and reduce inflammation over a year, with an option to continue treatment for up to 5 years. It is an early-phase trial, so while promising, it is not yet proven to work for all teens.

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 could provide a new daily pill option for adolescents with ulcerative colitis to control their disease and reduce flare-ups.
What could go wrong
This is a small, early-phase study with only 36 teens, so results may not apply to everyone. The drug requires ongoing daily use and may have side effects; it is not a cure.

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 36 people

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

Started

Dec 2022

Expected to finish

Jul 2033

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

12 to 17 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.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

How to take part

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

  1. The places running it

    44 sites in 5 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

  • ACT-Midwest G1

    RECRUITING

    Abilene, Texas, 79606, United States

  • Arkansas Children's

    NOT_YET_RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Arkansas Children's (IP Address)

    NOT_YET_RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Arnold Palmer Hospital - Center for Digestive Health and Nutrition

    RECRUITING

    Orlando, Florida, 32806, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Centrum Zdrowia MDM

    RECRUITING

    Warsaw, 00-189, Poland

  • Consorci Corporacio Sanitaria Parc Tauli

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Gunma University Hospital

    RECRUITING

    Maebashi, Gunma, 371-8511, Japan

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

    NOT_YET_RECRUITING

    Katowice, 40-600, Poland

  • Hospital Clinico Universitario de Santiago de Compostela

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

  • Hospital Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hyogo Medical University Hospital

    RECRUITING

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-730, Poland

  • Instytut Centrum Zdrowia Matki Polki

    ACTIVE_NOT_RECRUITING

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Ishii Eye Clinic

    RECRUITING

    Nagareyama-shi, Chiba, 270-0116, Japan

  • Japanese Red Cross Kyoto Daini Hospital

    RECRUITING

    Kyoto, 602-8026, Japan

  • Jichi Medical University Hospital

    RECRUITING

    Shimotsuke, Tochigi, 329 0498, Japan

  • Juntendo University Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • K.M. Management, spol. s r.o.

    RECRUITING

    Nitra, 949 01, Slovakia

  • Kinki University - Nara Hospital

    RECRUITING

    Ikoma, Nara, 630-0293, Japan

  • Loma Linda Children's Hospital

    NOT_YET_RECRUITING

    Loma Linda, California, 92354, United States

  • Loma Linda University Children's Hospital Pediatric Specialty Clinics

    NOT_YET_RECRUITING

    San Bernardino, California, 92408, United States

  • Loma Linda University Clinical Trial Center

    NOT_YET_RECRUITING

    Loma Linda, California, 92354, United States

  • Loma Linda University Eye Institute

    NOT_YET_RECRUITING

    Loma Linda, California, 92354, United States

  • Loma Linda University Medical Center

    NOT_YET_RECRUITING

    Loma Linda, California, 92354, United States

  • Loma Linda University Pediatric Clinics

    NOT_YET_RECRUITING

    Loma Linda, California, 92354, United States

  • Saga University Hospital

    RECRUITING

    Saga, 849-8501, Japan

  • Saitama Prefectural Children's Medical Center

    RECRUITING

    Saitama-shi, Saitama, 330-8777, Japan

  • Toyama Prefectural Central Hospital

    RECRUITING

    Toyama, 930-8550, Japan

  • Tsujinaka Hospital - Kashiwanoha

    RECRUITING

    Kashiwa, Chiba, 277-0871, Japan

  • Twoja Przychodnia - Szczecińskie Centrum Medyczne

    RECRUITING

    Szczecin, 71-434, Poland

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of California San Francisco,

    RECRUITING

    San Francisco, California, 94158, United States

  • University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Uniwersytecki Szpital Dziecięcy w Krakowie

    RECRUITING

    Krakow, 30-663, Poland

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    RECRUITING

    Wroclaw, 50-369, Poland

  • Valley View Wellness Medical Center

    RECRUITING

    Garden Grove, California, 92845, United States

  • WIP Warsaw IBD Point Profesor Kierkus

    RECRUITING

    Warsaw, 00-728, Poland

  • WIP Warsaw IBD Point Profesor Kierkuś

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-501, Poland

  • William Beaumont Hospital/Corewell Health - East

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • William Beaumont Hospitals Reference Laboratory

    RECRUITING

    Royal Oak, Michigan, 48073, United States

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