Phase 2
Completed N=118
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov NCT02536404 ↗Enrolled (actual)
118
Serious AEs
5.9%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) — 67; 5; 7; 0 Participants
Summary
The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) |
67; 5; 7; 0 | — |
| SECONDARY Proportion of Participants Who Achieved Clinical Response |
78.6; 75.0 | — |
| SECONDARY Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005 |
39.3; 50.0 | — |
| SECONDARY Proportion of Participants Who Achieved Clinical Remission |
39.3; 25.0 | — |
| SECONDARY Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005 |
14.3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who completed the APD334-003 (NCT02447302) study
Exclusion Criteria
- Participants who did not complete the APD334-003 study
Data sourced from ClinicalTrials.gov (NCT02536404). 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.