Status:
COMPLETED
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Arena is a wholly owned subsidiary of Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04706793
Start Date
December 25 2020
End Date
August 3 2022
Last Update
October 16 2023
Active Locations (38)
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1
Kojunkai Daido Clinic
Nagoya, Aichi-ken, Japan, 457-8511
2
Kojunkai Daido Hospital
Nagoya, Aichi-ken, Japan, 457-8511
3
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
4
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan, 441-8570