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

NCT07470879 · tracked via the Priya Life Science Germany tracker

Sponsor

Pfizer

Phase

Phase 2

Started

2026-05-28

Last updated

2026-08-24

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

Etrasimod →

Etrasimod: Once daily by mouth

Study summary

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).

Eligibility

Sex

ALL

Min age

2 Years

Max age

11 Years

Healthy volunteers

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

Primary outcome measure(s)

Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 — Week 52
Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.

Trial sites (42)

Facility	City	Region	Status
Fink Children's Ambulatory Care Center	New York	New York	Recruiting
Kimmel Pavilion - NYU Langone	New York	New York	Recruiting
NYU Grossman School of Medicine	New York	New York	Recruiting
NYU Langone Health (Tisch Hospital)	New York	New York	Recruiting
NYU Langone Inflammatory Bowel Disease Center	New York	New York	Recruiting
NYU Langone Radiology - Tisch Hospital	New York	New York	Recruiting
NYU Medical Science Building (MSB)	New York	New York	Recruiting
The Children's Hospital at Westmead	Westmead	New South Wales	Recruiting
Monash Health	Clayton	Victoria	Recruiting
Perth Children's Hospital	Perth	Western Australia	Not Yet Recruiting
Health Sciences Centre Winnipeg	Winnipeg	Manitoba	Recruiting
Children's Hospital Research Institute of Manitoba	Winnipeg	Manitoba	Recruiting
CHU de Québec - Université Laval	Québec	Quebec	Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant	Bron	Auvergne-Rhône-Alpes	Recruiting
Hôpital Universitaire Necker Enfants Malades	Paris	France	Recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus	Münster	North Rhine-Westphalia	Recruiting
Universitätsklinikum Leipzig	Leipzig	Saxony	Recruiting
Universitaetsklinikum Tuebingen	Tübingen	Germany	Recruiting
HELIOS Klinikum Wuppertal	Wuppertal	Germany	Recruiting
Sheba Medical Center	Ramat Gan	Central District	Recruiting
Kaplan Medical Center Pharmacy	Rehovot	Central District	Recruiting
Kaplan Medical Center	Rehovot	Central District	Recruiting
Yitzhak Shamir Medical Center	Ẕerifin	Central District	Recruiting
Shaare Zedek Medical Center	Jerusalem	Jerusalem	Recruiting
Hadassah Medical Center	Jerusalem	Jerusalem	Recruiting
Rambam Health Care Campus	Haifa	Northern District	Recruiting
Carmel Medical Center	Haifa	Northern District	Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII	Bergamo	Lombardy	Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	Lombardy	Not Yet Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Tuscany	Not Yet Recruiting
Saitama Prefectural Children's Medical Center	Saitama-shi	Saitama	Recruiting
Japanese Red Cross Kumamoto Hospital	Kumamoto	Japan	Recruiting
Juntendo University Hospital	Tokyo	Japan	Recruiting
Centrum Zdrowia MDM	Warsaw	Masovian Voivodeship	Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś	Warsaw	Masovian Voivodeship	Recruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero	Katowice	Poland	Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka"	Warsaw	Poland	Recruiting
King's College Hospital	London	London, CITY of	Recruiting
Bristol Royal Hospital for Children	Bristol	United Kingdom	Not Yet Recruiting
Alder Hey Children's Hospital	Liverpool	United Kingdom	Recruiting

+ 2 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis Recruiting

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC Active, not recruiting

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis Recruiting

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07470879 on ClinicalTrials.gov ↗ ← All trials in Germany