Phase 2
Completed N=156
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
Source: ClinicalTrials.gov NCT02447302 ↗Enrolled (actual)
156
Serious AEs
5.8%
Results posted
Apr 2021
Primary outcomePrimary: Change From Baseline in Adapted Mayo Score (MCS) at Week 12 — -1.94; -2.49; -1.50 score on a scale — p== 0.0091
Summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Adapted Mayo Score (MCS) at Week 12 |
-1.94; -2.49; -1.50 | = 0.0091 sig |
| SECONDARY Percentage of Participants Who Achieved Endoscopic Improvement at Week 12 |
22.5; 41.8; 17.8 | = 0.003 sig |
| SECONDARY Change From Baseline in 2-component MCS at Week 12 |
-1.30; -1.75; -0.92 | = 0.0020 sig |
| SECONDARY Change From Baseline in Total Mayo Score (TMS) at Week 12 |
-2.69; -3.35; -2.08 | = 0.0100 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02447302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.