Status:
RECRUITING
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Arena is a wholly owned subsidiary of Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 7 2031
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05287126
Start Date
December 16 2022
End Date
August 7 2031
Last Update
July 8 2025
Active Locations (46)
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1
Arkansas Children's (IP Address)
Little Rock, Arkansas, United States, 72202
2
Arkansas Children's
Little Rock, Arkansas, United States, 72202
3
Valley View Wellness Medical Center
Garden Grove, California, United States, 92845
4
Loma Linda Children's Hospital
Loma Linda, California, United States, 92354