Phase 3
N=433
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT03945188 ↗Enrolled (actual)
433
Serious AEs
6.7%
Results posted
Dec 2022
Primary outcome: Primary: Percentage of Participants Achieving Clinical Remission at Week 12 — 27.0; 7.4 Percentage of participants — p=<0.001
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
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Clinical Remission at Week 12 |
27.0; 7.4 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving Clinical Remission at Week 52 |
32.1; 6.7 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Endoscopic Improvement at Week 12 |
35.0; 14.1 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Endoscopic Improvement at Week 52 |
37.2; 10.4 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Symptomatic Remission at Week 12 |
46.0; 21.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Symptomatic Remission at Week 52 |
43.4; 18.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 12 |
21.2; 4.4 | <0.001 sig |
| SECONDARY Percentage of Participants With Mucosal Healing at Week 52 |
26.6; 8.1 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52 |
32.1; 6.7 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52 |
17.9; 2.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 12 |
62.4; 34.1 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 52 |
48.2; 23.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52 |
44.9; 18.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52 |
13.5; 2.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Endoscopic Normalization at Week 12 |
14.6; 4.4 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Endoscopic Normalization at Week 52 |
26.3; 5.9 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52 |
10.6; 1.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Symptomatic Remission by Study Visit |
15.3; 8.9; 28.1; 13.3; 37.6; 20.7 | =0.049 sig |
| SECONDARY Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit |
5.8; 2.2; 11.3; 4.4; 16.8; 6.7 | =0.057 |
| SECONDARY Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit |
38.3; 33.3; 56.2; 39.3; 63.1; 43.0 | =0.336 |
| SECONDARY Percentage of Participants Achieving Symptomatic Response by Study Visit |
39.4; 33.3; 57.3; 40.0; 64.6; 43.7 | =0.240 |
| SECONDARY Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline |
31.0; 7.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12 |
49.1; 17.4 | <0.001 sig |
Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
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 (NCT03945188). 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.