A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
About the study
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 study enrollment), or until marketing authorization is obtained in the participant's country, whichever comes first.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Ulcerative Colitis
Age (in years)
12 - 17
Phase
Phase 2
Participants needed
36
Est. Completion Date
Dec 19, 2029
Treatment type
Interventional
Sponsor
Pfizer
ClinicalTrials.gov identifier
NCT05287126
Study number
APD334-207
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