Phase 2
N=234
Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT04607837 ↗Enrolled (actual)
234
Serious AEs
4.7%
Results posted
Jul 2025
Primary outcome: Primary: Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS) — 26.0; 18.3 Percentage of participants — p=0.2524
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etrasimod (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS) |
26.0; 18.3 | 0.2524 |
| SECONDARY Percentage of Participants Achieving Clinical Remission at Week 12 Using MMS |
28.3; 11.7 | 0.0068 sig |
| SECONDARY Percentage of Participants Achieving Endoscopic Improvement at Week 52 |
32.3; 23.3 | 0.2302 |
| SECONDARY Percentage of Participants Achieving Symptomatic Remission at Week 52 |
37.0; 30.0 | 0.3339 |
| SECONDARY Percentage of Participants Achieving Complete Symptomatic Remission at Week 52 |
20.5; 20.0 | 0.9141 |
| SECONDARY Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 52 |
25.2; 15.0 | 0.1089 |
| SECONDARY Percentage of Participants Achieving Clinical Remission at Both Weeks 12 and 52 [Combined] Using MMS |
16.5; 5.0 | 0.0104 sig |
| SECONDARY Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS |
16.2; 16.7 | 0.9203 |
| SECONDARY Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS |
25.2; 16.7 | 0.1726 |
| SECONDARY Percentage of Participants Achieving 4-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS |
30.0; 30.0 | 0.9272 |
| SECONDARY Percentage of Participants With 4-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS |
25.2; 16.7 | 0.1726 |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 12 Using MMS |
55.9; 36.7 | 0.0151 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 52 Using MMS |
44.1; 38.3 | 0.4419 |
| SECONDARY Percentage of Participants Achieving Endoscopic Improvement at Week 12 |
44.1; 20.0 | 0.0007 sig |
| SECONDARY Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 12 |
29.1; 13.3 | 0.0128 sig |
| SECONDARY Percentage of Participants Achieving Symptomatic Remission at Week 12 |
36.2; 25.0 | 0.1492 |
| SECONDARY Percentage of Participants Achieving Complete Symptomatic Remission at Week 12 |
20.5; 20.0 | 0.9774 |
| SECONDARY Percentage of Participants Achieving Change From Baseline in Both ES and RB or in Both ES and SF at Week 12 |
44.9; 21.7 | 0.0011 sig |
| SECONDARY Percentage of Participants Achieving Histologic Response Based on the Geboes Grading System at Week 12 |
44.9; 33.3 | 0.1513 |
| SECONDARY Percentage of Participants Achieving Histologic Response Based on Robarts Histopathology Index (RHI) at Week 12 |
46.5; 35.0 | 0.1823 |
Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
- Active UC confirmed by endoscopy
- Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
- Received a surveillance colonoscopy within 12 months before baseline
Exclusion Criteria
- Severe extensive colitis
- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
- Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening
Data sourced from ClinicalTrials.gov (NCT04607837). 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.