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