Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

• Status: Completed
• Trial end date: 2018-02-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arena Pharmaceuticals

Criteria

Inclusion Criteria:

• Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score

• Evidence of colonic ulcerative colitis activity on endoscopy

Exclusion Criteria:

• Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol

• Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent

• Any prior exposure to natalizumab, efalizumab, or rituximab