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

Recruiting now · Phase 2

Conditions studied: Colitis, Ulcerative

In brief

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).

Key facts

Study ID

NCT07470879

Run by

Pfizer

People needed

24

Starts

2026-05-28

Expected to finish

2034-08-18

Last updated by the study team

2026-06-26

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sheffield Children's Hospital — Sheffield, United Kingdom (enrolling)
• Shaare Zedek Medical Center — Jerusalem, Jerusalem, Israel (enrolling)
• Hadassah Medical Center — Jerusalem, Jerusalem, Israel (enrolling)
• Saitama Prefectural Children's Medical Center — Saitama-shi, Saitama, Japan (enrolling)
• Japanese Red Cross Kumamoto Hospital — Kumamoto, Japan (enrolling)
• Juntendo University Hospital — Tokyo, Japan (enrolling)
• Centrum Zdrowia MDM — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice, Poland (enrolling)
• Instytut "Pomnik - Centrum Zdrowia Dziecka" — Warsaw, Poland (enrolling)
• Evelina London Children's Hospital — London, United Kingdom (enrolling)
• CHU de Québec - Université Laval — Québec, Quebec, Canada (enrolling)
• Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron, Auvergne-Rhône-Alpes, France (enrolling)
• Universitaetsklinikum Tuebingen — Tübingen, Germany (enrolling)
• HELIOS Klinikum Wuppertal — Wuppertal, Germany (enrolling)
• Children's Hospital Research Institute of Manitoba — Winnipeg, Manitoba, Canada
• Health Sciences Centre Winnipeg — Winnipeg, Manitoba, Canada
• King's College Hospital — London, London, CITY of, United Kingdom
• Hôpital Universitaire Necker Enfants Malades — Paris, France
• Universitätsklinikum Münster - Albert Schweitzer Campus — Münster, North Rhine-Westphalia, Germany
• Universitätsklinikum Leipzig — Leipzig, Saxony, Germany
• Rambam Health Care Campus — Haifa, Northern District, Israel
• Azienda Ospedaliera Universitaria Meyer IRCCS — Florence, Tuscany, Italy
• Sheba Medical Center — Ramat Gan, Central District, Israel
• Yitzhak Shamir Medical Center — Ẕerifin, Central District, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.