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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-25

Study Completion Date

2022-08-03

Brief Summary

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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).

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Etrasimod 2 mg

Group Type EXPERIMENTAL

Etrasimod

Intervention Type DRUG

Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks

Interventions

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Etrasimod

Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks

Intervention Type DRUG

Placebo

Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks

Intervention Type DRUG

Other Intervention Names

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APD334

Eligibility Criteria

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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

* 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

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Kojunkai Daido Clinic

Nagoya, Aichi-ken, Japan

Site Status

Kojunkai Daido Hospital

Nagoya, Aichi-ken, Japan

Site Status

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

Site Status

Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, Japan

Site Status

Ishii Eye Clinic

Nagareyama-shi, Chiba, Japan

Site Status

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Site Status

Takimoto Eye Clinic(OCT)

Kasuga-shi, Fukuoka, Japan

Site Status

Fakuoka Tokushukai Hospital

Kasuga-shi, Fukuoka, Japan

Site Status

Gifu University Hospital

Gifu, Gifu, Japan

Site Status

SUBARU Health Insurance Society Ota Memorial Hospital

Ota-shi, Gunma, Japan

Site Status

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Site Status

Asahikawa City Hospital

Asahikawa-shi, Hokkaido, Japan

Site Status

NHO Mito Medical Center

Higashiibaraki-gun, Ibaraki, Japan

Site Status

Matsumoto Eye Clinic

Toride-shi, Ibaraki, Japan

Site Status

NHO Kanazawa Medical Center

Kanazawa, Ishikawa-ken, Japan

Site Status

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, Japan

Site Status