Etrasimod for Teens With Moderate to Severe Ulcerative Colitis
Tests etrasimod in adolescents aged 12 to 17 with ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Key facts
- Where
- Leuven, BelgiumSee the site
- 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 12 and 17 years old?
Source: NCT05287126, who can take part
Where in Belgium
- UZ LeuvenLeuven, BelgiumNo longer taking part
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
- NCT05287126EU 2022-500345-25-00
- Record updated
- 27 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 adolescents (≥ 12 years up to < 18 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
An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent 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 adolescents (≥ 12 years up to < 18 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: Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD; Severe extensive colitis; Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis.