Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
Status: | Completed |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 2/17/2019 |
Start Date: | July 2015 |
End Date: | February 14, 2018 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment
for ulcerative colitis.
for ulcerative colitis.
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 or any other investigational or approved biologic
agent
- Any prior exposure to natalizumab, efalizumab, or rituximab
We found this trial at
31
sites
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