Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
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UCRecruiting

A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

Phase 2 · Testing Etrasimod · 42 sites · Pfizer

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Etrasimod (a drug) as a possible treatment. Condition(s) listed: Colitis, Ulcerative.

It is open-label: participants know what they are receiving.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

Some of the main requirements, copied from the record:

There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to < 12 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhasePhase 2
Study typeInterventional
ConditionsColitis, Ulcerative
Lead sponsorPfizer
Enrollment24 (estimated)
Start date2026-05-28
Primary completion (est.)2030-09-08
First posted2026-03-13
Last updated2026-08-24
Official titleA PHASE 2 OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS, AND SAFETY OF ETRASIMOD IN PEDIATRIC PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
ClinicalTrials.gov IDNCT07470879

Interventions

Full eligibility criteria (from the record)
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

Locations (42)

Show all 42 sites
SiteCityCountrySite status
Fink Children's Ambulatory Care CenterNew York, New YorkUnited StatesRecruiting
Kimmel Pavilion - NYU LangoneNew York, New YorkUnited StatesRecruiting
NYU Grossman School of MedicineNew York, New YorkUnited StatesRecruiting
NYU Langone Health (Tisch Hospital)New York, New YorkUnited StatesRecruiting
NYU Langone Inflammatory Bowel Disease CenterNew York, New YorkUnited StatesRecruiting
NYU Langone Radiology - Tisch HospitalNew York, New YorkUnited StatesRecruiting
NYU Medical Science Building (MSB)New York, New YorkUnited StatesRecruiting
The Children's Hospital at WestmeadWestmead, New South WalesAustraliaRecruiting
Monash HealthClayton, VictoriaAustraliaRecruiting
Perth Children's HospitalPerth, Western AustraliaAustraliaNot yet recruiting
Health Sciences Centre WinnipegWinnipeg, ManitobaCanadaRecruiting
Children's Hospital Research Institute of ManitobaWinnipeg, ManitobaCanadaRecruiting
CHU de Québec - Université LavalQuébec, QuebecCanadaRecruiting
Hôpital Universitaire Necker Enfants MaladesParisFranceRecruiting
Hospices Civils de Lyon - Hôpital Femme Mère EnfantBron, Auvergne-Rhône-AlpesFranceRecruiting
Universitaetsklinikum TuebingenTübingenGermanyRecruiting
HELIOS Klinikum WuppertalWuppertalGermanyRecruiting
Universitätsklinikum Münster - Albert Schweitzer CampusMünster, North Rhine-WestphaliaGermanyRecruiting
Universitätsklinikum LeipzigLeipzig, SaxonyGermanyRecruiting
Sheba Medical CenterRamat Gan, Central DistrictIsraelRecruiting
Kaplan Medical Center PharmacyRehovot, Central DistrictIsraelRecruiting
Kaplan Medical CenterRehovot, Central DistrictIsraelRecruiting
Yitzhak Shamir Medical CenterẔerifin, Central DistrictIsraelRecruiting
Shaare Zedek Medical CenterJerusalem, JerusalemIsraelRecruiting
Hadassah Medical CenterJerusalem, JerusalemIsraelRecruiting
Rambam Health Care CampusHaifa, Northern DistrictIsraelRecruiting
Carmel Medical CenterHaifa, Northern DistrictIsraelRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, LombardyItalyRecruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilan, LombardyItalyNot yet recruiting
Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, TuscanyItalyNot yet recruiting
Japanese Red Cross Kumamoto HospitalKumamotoJapanRecruiting
Juntendo University HospitalTokyoJapanRecruiting
Saitama Prefectural Children's Medical CenterSaitama-shi, SaitamaJapanRecruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział LiberoKatowicePolandRecruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka"WarsawPolandRecruiting
Centrum Zdrowia MDMWarsaw, Masovian VoivodeshipPolandRecruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor KierkuśWarsaw, Masovian VoivodeshipPolandRecruiting
Bristol Royal Hospital for ChildrenBristolUnited KingdomNot yet recruiting
Alder Hey Children's HospitalLiverpoolUnited KingdomRecruiting
Evelina London Children's HospitalLondonUnited KingdomRecruiting
Sheffield Children's HospitalSheffieldUnited KingdomRecruiting
King's College HospitalLondon, London, CITY ofUnited KingdomRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.