A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Recruiting
Phase 2
Interventional Study
Ulcerative Colitis
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
- 12 – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 36 (estimated)
- Sponsor
- Pfizer · Industry
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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 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…
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 coliti…
Contacts