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
- Diseases
- Ulcerative colitis
- 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
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queensland Children's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Not yet recruiting |
| CHU de Quebec-Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Health Sciences Centre Winnipeg Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
| Children's Hospital Research Institute of Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Helios Universitaetsklinikum Wuppertal Coordinator of this site? Confirm its status | Wuppertal | Germany | Recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Not yet recruiting |
| Robert Debre University Hospital Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Bristol Royal Hospital for Children Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Alder Hey Children's Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Evelina London Children's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Kaplan Medical Center Coordinator of this site? Confirm its status | Rehovot | Israel | Recruiting |
| Yitzhak Shamir Medical Center Coordinator of this site? Confirm its status | Tsrifin | Israel | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Japanese Red Cross Kumamoto Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Saitama Prefectural Children's Medical Center Coordinator of this site? Confirm its status | Saitama-Shi | Japan | Recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Uniwersytecki Szpital Dzieciecy W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Gyncentrum Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Eb Group Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Univerzitna nemocnica Martin Coordinator of this site? Confirm its status | Martin | Slovakia | Completed |
| KM Management spol. s r.o. Coordinator of this site? Confirm its status | Nitra | Slovakia | Completed |
| IU Health North Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Riley Hospital for Children at IU Health Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Investigational Drug Services - Riley Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| NYU Langone Radiology - Tisch Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYU Langone Health - Tisch Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYU Langone Inflammatory Bowel Disease Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Kimmel Pavilion - NYU Langone Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYU Grossman School of Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYU Medical Science Building (MSB) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Fink Children's Ambulatory Care Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.