Overview
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2028-10-01
2028-10-01
Target enrollment:
0
0
Participant gender:
All
All
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 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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Arena Pharmaceuticals
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 presence or history
of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis