Phase 3
Completed N=354
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov NCT03996369 ↗Enrolled (actual)
354
Serious AEs
2.3%
Results posted
Dec 2022
Primary outcomePrimary: Percentage of Participants Achieving Clinical Remission — 24.8; 15.2 Percentage of participants — p==0.026
◆ Published Evidence
Emerging
5citations · ~5 / year
Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From the ELEVATE UC Clinical Program.
Summary
The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
Linked Publications (5)
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Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From the ELEVATE UC Clinical Program.
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Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Baseline Modified Mayo Score: A Post Hoc Analysis From the Phase 3 ELEVATE UC Clinical Program.
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Etrasimod for the symptomatic relief of ulcerative colitis: a post-hoc analysis from the ELEVATE UC clinical programme.
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Efficacy of Etrasimod in Ulcerative Colitis: Analysis of ELEVATE UC 52 and ELEVATE UC 12 by Baseline Endoscopic Severity.
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Rapid symptomatic improvement with etrasimod in ulcerative colitis: a post-hoc analysis of the ELEVATE UC program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Clinical Remission |
24.8; 15.2 | =0.026 sig |
| SECONDARY Percentage of Participants Achieving Endoscopic Improvement |
30.6; 18.8 | =0.009 sig |
| SECONDARY Percentage of Participants Achieving Symptomatic Remission |
46.8; 29.5 | =0.001 sig |
| SECONDARY Percentage of Participants With Mucosal Healing |
16.2; 8.9 | =0.036 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response |
62.2; 41.1 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Endoscopic Normalization |
17.1; 8.0 | =0.009 sig |
| SECONDARY Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8 |
16.2; 10.7; 27.5; 16.1; 38.7; 24.1 | =0.115 |
| SECONDARY Percentage of Participants Achieving Complete Symptomatic Remission |
4.5; 1.8; 11.7; 3.6; 14.0; 7.1 | =0.128 |
| SECONDARY Percentage of Participants Achieving Non-invasive Clinical Response |
39.2; 24.1; 55.9; 41.1; 68.0; 45.5 | =0.002 sig |
| SECONDARY Percentage of Participants Achieving Symptomatic Response |
39.6; 24.1; 56.3; 41.1; 68.5; 46.4 | =0.002 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- Active UC confirmed by endoscopy
Exclusion Criteria
- Severe extensive colitis
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Data sourced from ClinicalTrials.gov (NCT03996369) and the linked publication. 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.