Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Participants With Moderately to Severely Active Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Etrasimod
* Drug: Etrasimod
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese ancestry Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening Having active UC confirmed by endoscopy Moderately to severely active UC Exclusion Criteria: Severe extensive colitis Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etrasimod Dose 1<br> | Drug: Etrasimod<br>* Etrasimod tablet by mouth, once daily for 12 weeks<br>* Other names: APD334;|
| Experimental: Etrasimod Dose 2<br> | Drug: Etrasimod<br>* Etrasimod tablet by mouth, once daily for 12 weeks<br>* Other names: APD334;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving Clinical Remission |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving Endoscopic Improvement |  | Week 12 | 
| Proportion of Participants Achieving Symptomatic Remission |  | Week 12 | 
| Proportion of Participants with Mucosal Healing |  | Week 12 | 
| Proportion of Participants Achieving Clinical Response |  | Week 12 | 
| Proportion of Participants Achieving Endoscopic Normalization |  | Week 12 | 
| Number and Severity of Adverse Events | Safety will be assessed by monitoring adverse events and clinically significant changes in vital signs and clinical laboratory results. | up to approximately 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, APD334, Etrasimod