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

NCT04706793

CompletedPhase 3

Sponsor: Pfizer

Conditions: Ulcerative Colitis

Interventions: Etrasimod, Placebo

Countries: Japan

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).

Eligibility overview

Sex: ALL

Age: 16 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (38)

Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Kashiwa-shi, Chiba, Japan
Nagareyama-shi, Chiba, Japan
Fukuoka, Fukuoka, Japan
Kasuga-shi, Fukuoka, Japan
Kasuga-shi, Fukuoka, Japan
Gifu, Gifu, Japan
Ota-shi, Gunma, Japan
Hiroshima, Hiroshima, Japan
Asahikawa-shi, Hokkaido, Japan
Higashiibaraki-gun, Ibaraki, Japan
Toride-shi, Ibaraki, Japan
Kanazawa, Ishikawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Tsu, Mie-ken, Japan
Yokkaichi-shi, Mie-ken, Japan
Sendai, Miyagi, Japan
Sendai, Miyagi, Japan
+ 8 more on CT.gov