Phase 3
N=354
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT03996369 ↗Enrolled (actual)
354
Serious AEs
2.3%
Results posted
Dec 2022
Primary outcome: Primary: Percentage of Participants Achieving Clinical Remission — 24.8; 15.2 Percentage of participants — p==0.026
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Etrasimod (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Arena Pharmaceuticals
- Primary completion
- Dec 2021
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 |
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).
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). 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.