A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug:

Placebo Phase: Phase 3

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Everstar Therapeutics Limited

Criteria

Inclusion Criteria:

1. A documented of diagnosis with UC at least 6 months prior to screening.

2. Have active UC extending proximal to the rectum confirmed on endoscopy (≥ 15 cm involved)

Exclusion Criteria:

1. Have severe extensive colitis

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

3. Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia