Overview

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Status:
Not yet recruiting

Trial end date:
2028-10-01

Target enrollment:
0

Participant gender:
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 2

Accepts Healthy Volunteers?

Details

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