A Phase 3 interventional study of Etrasimod in Ulcerative Colitis, sponsored by Pfizer. Active, not recruiting at 472 sites in 39 countries. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
Among 12 studies testing etrasimod in Colitis, Ulcerative — 3 open to participants now, 5 under way, 2 of them phase 3. etrasimod · Colitis, Ulcerative.
Among the 12 studies testing etrasimod in Colitis, Ulcerative, this one has the largest enrollment, is one of 3 that started in 2019, is one of 5 in phase 3, and was the 4th registered.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's enrollment of 896 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →3 of the 12 studies testing etrasimod in Colitis, Ulcerative are open now, in 12 countries. Each count lists the studies.
etrasimod: first FDA approval 2023 (VELSIPITY), first EMA approval 2024. What it is approved for, and how studies give it, is on its page →
Of the 305 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 134 (44%) stop at 75 or younger; 71 take children under 18; 40 take healthy volunteers.
This study: 16 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 3 started in 2019.
Median enrollment 195 across the 12 interventional studies. Of the 7 that completed or were terminated, 7 (100%) have results posted.
11 of 12 have an industry lead sponsor. The 4 most frequent:
Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
37 studies in Colitis, Ulcerative by Pfizer: 4 open now, 8 under way, 2 of them phase 3. Of 27 finished, 22 (81%) have results posted.
Among the 37 studies in Colitis, Ulcerative by Pfizer, this one is the 2nd largest by enrollment of the 20 interventional ones, is one of 2 that started in 2019, is one of 7 in phase 3, and was the 17th registered.
Pfizer’s Colitis, Ulcerative studies by the year they started, since 2005.
1 of the studies testing etrasimod in Colitis, Ulcerative that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07782242Sir Run Run Shaw HospitalComaprison of Efficacy and Safety Between Etrasimod vs Mesalazine in Chinese Adults With Active UC | 2027-06-30 |
Among the 12 studies testing etrasimod in Colitis, Ulcerative, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Pfizer’s 37 in Colitis, Ulcerative:
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:
Exclusion Criteria:
Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first
Also known as: APD334
Number and Severity of Safety Measures
Safety as assessed by the evaluation of adverse events
Time frame: Up to approximately 8 years
Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
Time frame: Week 52 and Week 104
Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry
Time frame: Week 52 and Week 104
Change From Baseline in the Total Mayo Score
The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in Partial Mayo Score
The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.
Time frame: Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
Time frame: Week 52 and Week 104
Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores
Time frame: Week 52 and Week 104
Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Time frame: Week 52 and Week 104
Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores
Time frame: Week 52 and Week 104
Time to Loss of Response Assessed by Mayo Component Sub-scores
Time frame: Up to Week 260
Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline
Time frame: Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260
Showing the first 100 of 472 sites across 39 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Started Sep 2019 (actual). Primary completion is estimated for Jun 2029, 117 months after the start.
Of 87 industry-sponsored phase 3 interventional studies under Colitis, Ulcerative, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 70. This study's planned 117 months is above that.
Counting every sponsor, half of 101 studies reached it within 48 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Etrasimod