RecruitingPhase 2

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

Canada, Germany, Japan24 participantsStarted 2026-05-30

Plain-language summary

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).

Who can participate

Age range2 Years – 11 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: 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 criteria: 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

What they're measuring

Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52

Timeframe: Week 52

Trial details

NCT IDNCT07470879

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-09-10

Contact for this trial

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

View on ClinicalTrials.gov More Colitis, Ulcerative trials