A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whichever comes first.

Official Title
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An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Etrasimod


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active Participants are permitted to be receiving a therapeutic dose of select UC therapies Exclusion criteria: Severe extensive colitis Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or 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: 12 Years
Maximum Age: 17 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etrasimod<br> | Drug: Etrasimod<br>* Etrasimod tablet by mouth, once daily up to 52 weeks of treatment.<br>* Other names: APD334;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) |  | 4 hours (± 15 minutes) post-dose | 
| Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod |  | pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | 
| Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 |  | Week 12 | 
| Proportion of Participants Achieving Endoscopic Improvement at Week 12 |  | Week 12 | 
| Proportion of Participants Achieving Endoscopic Improvement at Week 52 |  | Week 52 | 
| Proportion of Participants Achieving Symptomatic Remission at Week 12 |  | Week 12 | 
| Proportion of Participants Achieving Symptomatic Remission at Week 52 |  | Week 52 | 
| Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12 |  | Week 12 | 
| Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52 |  | Week 52 | 
| Proportion of Participants Achieving Clinical Response at Week 12 |  | Week 12 | 
| Proportion of Participants Achieving Clinical Response at Week 52 |  | Week 52 | 
| Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 |  | Week 12 | 
| Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52 |  | Week 52 | 
| Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12 |  | Week 12 | 
| Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at 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 Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Adolescents, Active Ulcerative Colitis, APD334