Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis

Conditions
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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: 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

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 2 mg<br> | Drug: Etrasimod<br>* Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment<br>* Other names: APD334;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment<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 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving Clinical Remission |  | Week 12 | 
| Proportion of Participants Achieving Endoscopic Improvement |  | Week 52 | 
| Proportion of Participants Achieving Symptomatic Remission |  | Week 52 | 
| Proportion of Participants Achieving Mucosal Healing |  | Week 52 | 
| Proportion of participants achieving clinical remission at both Weeks 12 and 52 |  | Week 12 and Week 52 | 
| Proportion of Participants achieving clinical remission at Week 52 and who had not been receiving corticosteroids for ≥ 12 weeks immediately prior to Week 52 |  | Week 52 | 
| Number and Severity of Adverse Events | Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results. | Up to approximately 56 weeks (52-Week Treatment Period and 4-Week Follow-Up Period) | 

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