Overview
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.
Eligibility
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