A Study of how Medicine “Etrasimod“ works in Children with the gut Disease Called Ulcerative Colitis
Research type
Research Study
Full 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
IRAS ID
1013053
Contact name
Pauline Baur
Contact email
Sponsor organisation
Pfizer Inc.
Research summary
This study is testing a medicine called etrasimod to see how well it works, how it behaves in the body, and how safe it is for children aged 2 to under 12 who have moderate to severe ulcerative colitis (UC)—a condition that causes inflammation in the gut (colon).\nThe medicine comes in a granule form (like small particles) that kids can take with soft food, and the study will also check if children like the taste.\nChildren can keep taking their current UC medicines by mouth, like drugs called 5-ASA and/or corticosteroids as long as the doses are stable.\nThe study could last up to 5 years, starting with a 1-year treatment period that follows the same plan as a previous adult study. This helps researchers compare results between adults and children. After that, there’s an option to continue for up to 4 more years to see long-term effects. There will also be follow-up visits after stopping the medicine to make sure it’s still safe
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0263
Date of REC Opinion
4 Mar 2026
REC opinion
Further Information Favourable Opinion