Overview

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arena Pharmaceuticals
Criteria
Inclusion Criteria:

- Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening

- Active UC confirmed by endoscopy

- Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic
score ≥ 1

- Received a surveillance colonoscopy within 12 months before baseline

Exclusion Criteria:

- Severe extensive colitis

- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a
fistula consistent with Crohn's disease

- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

- Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks
prior to or after screening