Overview

Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will continue with the same blinded treatment assigned in Study APD334-302 for a total treatment duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arena Pharmaceuticals
Criteria
Inclusion Criteria:

Participants with moderately to severely active ulcerative colitis (UC) are eligible to
enroll into this study if they fulfill all of the following:

- Must have completed the Week 12 visit of Study APD334-302

- Ability to provide written informed consent or assent (parent or legal guardian must
provide consent for a participant < 20 years of age or as required per local
regulations who has assented to participate in the study) and to be compliant with the
schedule of protocol assessments. Enrollment of participants < 20 years should be
conducted only if acceptable according to local laws and regulations.

- Both men and women subjects agree to use a highly effective method of birth control if
the possibility of conception exists

Exclusion Criteria:

Participants who meet any of the following exclusion criteria will not be eligible for
enrollment into the study:

- If the Investigator considers the participant to be unsuitable for any reason to
participate in the study

- Participants requiring partial or total colectomy during the APD334-302 study

- Participants requiring treatment with prohibited concomitant medications