Etrasimod treatment for children with moderately to severely active ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives pediatric participants etrasimod and follows them closely for safety, effectiveness, and how the drug is processed in the body (pharmacokinetics) over a 52-week treatment period. Children who complete the 52 weeks may continue in a long-term extension for up to four additional years (five years total after enrollment). The study enrolls participants with moderately to severely active ulcerative colitis and permits some background UC therapies while excluding patients with Crohn’s disease, fistulas, severe extensive colitis, or other non-UC colitis types. Visits and monitoring occur at academic medical centers in Canada and Germany under sponsorship by Pfizer.

Why it matters

Who can join: the full rules

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

Where it's running

• Investigational Drug Services - Riley Hospital
  Indianapolis, Indiana, United States Recruiting
• IU Health North Hospital
  Indianapolis, Indiana, United States Recruiting
• Riley Hospital for Children at IU Health
  Indianapolis, Indiana, United States Recruiting
• Fink Children's Ambulatory Care Center
  New York, New York, United States Recruiting
• Kimmel Pavilion - NYU Langone
  New York, New York, United States Recruiting
• NYU Grossman School of Medicine
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.