Etrasimod for Moderately to Severely Active Ulcerative Colitis
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Recruiting
Phase 2
Interventional Study
Colitis, Ulcerative
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 11
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Pfizer · Industry
Who this trial is looking for
This trial is looking for children aged 2 to under 12 years who have moderately to severely active ulcerative colitis. Participants will take the medicine etrasimod for 52 weeks and may have the chance to continue in the study for up to 4 additional years.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with ulcerative colitis that is moderately to severely active
- I am between 2 and 12 years old
- I may be taking certain UC therapies
You may not be able to join if
- I have severe extensive colitis
- I have Crohn's disease or indeterminate colitis
- I have had or have a fistula related to Crohn's disease
- I have microscopic colitis
- I have ischemic colitis
- I have infectious colitis
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 …
Trial Locations
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Eligibility Criteria
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…
Contacts