A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3

Official Title
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A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Conditions
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Moderately to Severely Active Ulcerative Colitis

Intervention / Treatment
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* Drug: Etrasimod
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A documented of diagnosis with UC at least 6 months prior to screening. Have active UC extending proximal to the rectum confirmed on endoscopy (≥ 15 cm involved) Exclusion Criteria: Have 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, infection colitis or colonic mucosal dysplasia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Etrasimod 2mg<br>2mg/tablet, administratered orally, once daily | Drug: Etrasimod<br>* Drug:Etrasimod Tablet other name:APD334<br>|
| Placebo Comparator: Placebo Comparator: Placebo<br>matching tablet, administratered orally, once daily | Drug: Placebo<br>* Drug:placebo Tablet<br>|
| Experimental: Etrasimod 2mg (optional open-label extension period)<br>2mg/tablet, administratered orally, once daily | Drug: Etrasimod<br>* Drug:Etrasimod Tablet other name:APD334<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS) | Clinical remission per mMS(endoscopy, rectal bleeding, stool frequency), ranging from 0-9 (normal to severe) | induction period week 12 | 
| Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS) | Clinical remission per mMS, ranging from 0-9 (normal to severe) | Maintenance period week 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore | Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe) | induction period week 12 | 
| Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS) | Clinical response per mMS, ranging from 0 to 9 (normal to severe). | induction period Week 12 | 
| Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore | Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe) | Maintenance period Week 40 | 
| Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS) | Clinical response per mMS, ranging from 0 to 9 (normal to severe) | Maintenance period Week 40 | 
| Proportion of Subjects who achieve symptomatic response over time | Symptomatic response per paritial Mayo score(rectal bleeding, stool frequency), ranging from 0-6(normal to severe) | Open label treatment period up to 40 Weeks | 
| Proportion of Subjects who achieve Symptomatic Remission over time | Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe) | Open label treatment period up to 40 Weeks |