Adults 18 to 80, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Adapted Mayo Score (MCS) at Week 12Primary· Baseline and Week 12
The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Group
Value
95% CI
Etrasimod 1 mg
-1.94
-2.45 – -1.42
Etrasimod 2 mg
-2.49
-3.01 – -1.98
Placebo
-1.50
-2.00 – -1.01
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12Secondary· Week 12
For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used t
Group
Value
95% CI
Etrasimod 1 mg
22.5
Etrasimod 2 mg
41.8
Placebo
17.8
Change From Baseline in 2-component MCS at Week 12Secondary· Baseline and Week 12
The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Group
Value
95% CI
Etrasimod 1 mg
-1.30
-1.66 – -0.95
Etrasimod 2 mg
-1.75
-2.11 – -1.40
Placebo
-0.92
-1.26 – -0.57
Change From Baseline in Total Mayo Score (TMS) at Week 12Secondary· Baseline and Week 12
The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores \[stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score\], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Group
Value
95% CI
Etrasimod 1 mg
-2.69
-3.36 – -2.02
Etrasimod 2 mg
-3.35
-4.03 – -2.68
Placebo
-2.08
-2.73 – -1.44
Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12Secondary· Week 12
The trichotomous composite score of clinical remission and clinical response at Week 12 is an ordinal categorical endpoint with 3 categories (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response, and 0 for achieving neither). Multiple imputation method was used to handle missing data.
Group
Value
95% CI
Etrasimod 1 mg
0.60
± 0.11
Etrasimod 2 mg
0.84
± 0.13
Placebo
0.41
± 0.09
Percentage of Participants Who Achieved Clinical Remission at Week 12Secondary· Week 12
A participant was considered to have achieved clinical remission if he/she had: 1) an endoscopy score using flexible proctosigmoidoscopy of 0 or 1 (excluding friability), 2) a rectal bleeding score of 0 or 1, and 3) a stool frequency score of 0 or 1 with a decrease of ≥1 point from baseline. Multiple imputation method was used to handle missing data.
Group
Value
95% CI
Etrasimod 1 mg
16.0
Etrasimod 2 mg
33.0
Placebo
8.1
Percentage of Participants Who Achieved Clinical Response at Week 12Secondary· Week 12
A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission defined above, or met criteria of clinical response. Clinical response was defined as a decrease in the adapted MCS of ≥ 2 points and a decrease of ≥ 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1.
Group
Value
95% CI
Etrasimod 1 mg
43.7
Etrasimod 2 mg
50.6
Placebo
32.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT07470879 — A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
· Phase 2
· not yet recruiting
NCT07153159 — A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding
· Phase 1
· recruiting
NCT06398626 — An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
· recruiting
NCT06294925 — A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
· recruiting
NCT05287126 — A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
· Phase 2
· recruiting
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti
· Phase 3
· recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
· Phase 2
· recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
· Phase 2
· recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD
· Phase 3
· recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ
· Phase 3
· recruiting
Other Arena Pharmaceuticals trials
Trials by the same sponsor.
NCT04655599 — Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
· Phase 1
· terminated
NCT03996369 — Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
· Phase 3
· completed
NCT04162769 — A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
· Phase 2
· completed
NCT04043455 — Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant
· Phase 2
· terminated
NCT03945188 — Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Arena Pharmaceuticals
Last refreshed: 5 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02447302.