An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

Official Title
-----------------
An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Etrasimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria: Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit Exclusion Criteria: If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study Experienced an adverse event that led to discontinuation from parent study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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 approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first<br>* Other names: APD334;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Severity of Safety Measures | Safety as assessed by the evaluation of adverse events | Up to approximately 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores |  | Week 52 and Week 104 | 
| Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry |  | Week 52 and Week 104 | 
| Change From Baseline in the Total Mayo Score | The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease. | Baseline, Week 52, and Week 104 | 
| Change From Baseline in Partial Mayo Score | The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease. | Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260 | 
| Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores |  | Week 52 and Week 104 | 
| Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores |  | Week 52 and Week 104 | 

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