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

RecruitingPhase 2Ages 2 Years - 11 YearsAllPfizer
NCT07470879 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Etrasimod
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Where

46 sites
Investigational Drug Services - Riley Hospital
Indianapolis, United States
IU Health North Hospital
Indianapolis, United States
Riley Hospital for Children at IU Health
Indianapolis, United States
Fink Children's Ambulatory Care Center
New York, United States
Kimmel Pavilion - NYU Langone
New York, United States
NYU Grossman School of Medicine
New York, United States
NYU Langone Health (Tisch Hospital)
New York, United States
NYU Langone Inflammatory Bowel Disease Center
New York, United States

…and 38 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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