Etrasimod for Children With Moderately to Severely Active Ulcerative Colitis
Tests etrasimod in young children with moderately to severely active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Key facts
- Where
- Indianapolis and New York, United StatesSee the 10 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 11 years old?
Source: NCT07470879, who can take part
Where in United States
- Investigational Drug Services - Riley HospitalIndianapolis, United StatesTaking people
- IU Health North HospitalIndianapolis, United StatesTaking people
- Riley Hospital for Children at IU HealthIndianapolis, United StatesTaking people
- Fink Children's Ambulatory Care CenterNew York, United StatesTaking people
- Kimmel Pavilion - NYU LangoneNew York, United StatesTaking people
- NYU Grossman School of MedicineNew York, United StatesTaking people
- NYU Langone Health - Tisch HospitalNew York, United StatesTaking people
- NYU Langone Inflammatory Bowel Disease CenterNew York, United StatesTaking people
- NYU Langone Radiology - Tisch HospitalNew York, United StatesTaking people
- NYU Medical Science Building (MSB)New York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT07470879EU 2025-523100-77-00
- Record updated
- 26 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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.