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
- Ages 2 to 11
- Any sex
Some of the main requirements, copied from the record:
- 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
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
- About 24 participants are expected to take part.
- Start date: 2026-05-28.
- Main results expected around 2030-09-08 (estimate from the record).
- 42 study sites listed (38 marked recruiting) in Australia, Canada, France, Germany and Israel and 5 more countries.
Main thing being measured
- Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 (Week 52)
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
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Colitis, Ulcerative |
| Lead sponsor | Pfizer |
| Enrollment | 24 (estimated) |
| Start date | 2026-05-28 |
| Primary completion (est.) | 2030-09-08 |
| First posted | 2026-03-13 |
| Last updated | 2026-08-24 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07470879 |
Interventions
- Etrasimod (Drug)
Once daily by mouth
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
| Site | City | Country | Site status |
|---|---|---|---|
| Fink Children's Ambulatory Care Center | New York, New York | United States | Recruiting |
| Kimmel Pavilion - NYU Langone | New York, New York | United States | Recruiting |
| NYU Grossman School of Medicine | New York, New York | United States | Recruiting |
| NYU Langone Health (Tisch Hospital) | New York, New York | United States | Recruiting |
| NYU Langone Inflammatory Bowel Disease Center | New York, New York | United States | Recruiting |
| NYU Langone Radiology - Tisch Hospital | New York, New York | United States | Recruiting |
| NYU Medical Science Building (MSB) | New York, New York | United States | Recruiting |
| The Children's Hospital at Westmead | Westmead, New South Wales | Australia | Recruiting |
| Monash Health | Clayton, Victoria | Australia | Recruiting |
| Perth Children's Hospital | Perth, Western Australia | Australia | Not yet recruiting |
| Health Sciences Centre Winnipeg | Winnipeg, Manitoba | Canada | Recruiting |
| Children's Hospital Research Institute of Manitoba | Winnipeg, Manitoba | Canada | Recruiting |
| CHU de Québec - Université Laval | Québec, Quebec | Canada | Recruiting |
| Hôpital Universitaire Necker Enfants Malades | Paris | France | Recruiting |
| Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Bron, Auvergne-Rhône-Alpes | France | Recruiting |
| Universitaetsklinikum Tuebingen | Tübingen | Germany | Recruiting |
| HELIOS Klinikum Wuppertal | Wuppertal | Germany | Recruiting |
| Universitätsklinikum Münster - Albert Schweitzer Campus | Münster, North Rhine-Westphalia | Germany | Recruiting |
| Universitätsklinikum Leipzig | Leipzig, Saxony | Germany | Recruiting |
| Sheba Medical Center | Ramat Gan, Central District | Israel | Recruiting |
| Kaplan Medical Center Pharmacy | Rehovot, Central District | Israel | Recruiting |
| Kaplan Medical Center | Rehovot, Central District | Israel | Recruiting |
| Yitzhak Shamir Medical Center | Ẕerifin, Central District | Israel | Recruiting |
| Shaare Zedek Medical Center | Jerusalem, Jerusalem | Israel | Recruiting |
| Hadassah Medical Center | Jerusalem, Jerusalem | Israel | Recruiting |
| Rambam Health Care Campus | Haifa, Northern District | Israel | Recruiting |
| Carmel Medical Center | Haifa, Northern District | Israel | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo, Lombardy | Italy | Recruiting |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan, Lombardy | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS | Florence, Tuscany | Italy | Not yet recruiting |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | Japan | Recruiting |
| Juntendo University Hospital | Tokyo | Japan | Recruiting |
| Saitama Prefectural Children's Medical Center | Saitama-shi, Saitama | Japan | Recruiting |
| Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero | Katowice | Poland | Recruiting |
| Instytut "Pomnik - Centrum Zdrowia Dziecka" | Warsaw | Poland | Recruiting |
| Centrum Zdrowia MDM | Warsaw, Masovian Voivodeship | Poland | Recruiting |
| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś | Warsaw, Masovian Voivodeship | Poland | Recruiting |
| Bristol Royal Hospital for Children | Bristol | United Kingdom | Not yet recruiting |
| Alder Hey Children's Hospital | Liverpool | United Kingdom | Recruiting |
| Evelina London Children's Hospital | London | United Kingdom | Recruiting |
| Sheffield Children's Hospital | Sheffield | United Kingdom | Recruiting |
| King's College Hospital | London, London, CITY of | United Kingdom | Recruiting |
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.