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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Placebo

Drug: Etrasimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT04706793

C5041013 (Other Identifier)

APD334-308

Details and patient eligibility

About

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).

Enrollment

42 patients

Sex

All

Ages

16 to 80 years old

Volunteers

No Healthy Volunteers

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