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NCT07470879RecruitingPhase 2

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

A 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

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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 enrollment).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
24 (estimated)
First submitted
10 Mar 2026
Start date
28 May 2026
Primary completion date
8 Sept 2030
Lead sponsor
Pfizer
NCT number
NCT07470879
EU CT number
2025-523100-77-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 24
  • From 28 May 2026 to the primary completion date, 8 Sept 2030
  • 53 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 2 years to 11 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queensland Children's Hospital
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BrisbaneAustraliaRecruiting
Monash Health
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ClaytonAustraliaRecruiting
Perth Children's Hospital
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PerthAustraliaRecruiting
The Children's Hospital at Westmead
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WestmeadAustraliaRecruiting
University of Alberta
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EdmontonCanadaNot yet recruiting
CHU de Quebec-Universite Laval
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QuébecCanadaRecruiting
Health Sciences Centre Winnipeg
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WinnipegCanadaRecruiting
Children's Hospital Research Institute of Manitoba
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WinnipegCanadaRecruiting
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyRecruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Helios Universitaetsklinikum Wuppertal
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WuppertalGermanyRecruiting
HUS-Yhtymae
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HelsinkiFinlandCompleted
Tampere University Hospital
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TampereFinlandCompleted
Hospices Civils de Lyon
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BronFranceNot yet recruiting
Robert Debre University Hospital
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ParisFranceNot yet recruiting
Hopital Necker Enfants Malades
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ParisFranceNot yet recruiting
Bristol Royal Hospital for Children
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BristolUnited KingdomRecruiting
Alder Hey Children's Hospital
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LiverpoolUnited KingdomRecruiting
King's College Hospital
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LondonUnited KingdomRecruiting
Evelina London Children's Hospital
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LondonUnited KingdomRecruiting
Sheffield Children's Hospital
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SheffieldUnited KingdomRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Carmel Medical Center
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HaifaIsraelRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Kaplan Medical Center
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RehovotIsraelRecruiting
Yitzhak Shamir Medical Center
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TsrifinIsraelRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Japanese Red Cross Kumamoto Hospital
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KumamotoJapanRecruiting
Saitama Prefectural Children's Medical Center
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Saitama-ShiJapanRecruiting
Juntendo University Hospital
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TokyoJapanRecruiting
Uniwersytecki Szpital Dzieciecy W Krakowie
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CracowPolandRecruiting
Gyncentrum Sp. z o.o.
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KatowicePolandRecruiting
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandRecruiting
Eb Group Sp. z o.o.
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WarsawPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Univerzitna nemocnica Martin
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MartinSlovakiaCompleted
KM Management spol. s r.o.
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NitraSlovakiaCompleted
IU Health North Hospital
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IndianapolisUnited StatesRecruiting
Riley Hospital for Children at IU Health
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IndianapolisUnited StatesRecruiting
Investigational Drug Services - Riley Hospital
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IndianapolisUnited StatesRecruiting
NYU Langone Radiology - Tisch Hospital
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New YorkUnited StatesRecruiting
NYU Langone Health - Tisch Hospital
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New YorkUnited StatesRecruiting
NYU Langone Inflammatory Bowel Disease Center
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New YorkUnited StatesRecruiting
Kimmel Pavilion - NYU Langone
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New YorkUnited StatesRecruiting
NYU Grossman School of Medicine
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New YorkUnited StatesRecruiting
NYU Medical Science Building (MSB)
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New YorkUnited StatesRecruiting
Fink Children's Ambulatory Care Center
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New YorkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.