Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Dec 17, 2023
  • participants needed
    96
  • sponsor
    Arena Pharmaceuticals
Updated on 17 June 2022
endoscopy

Summary

The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.

Details
Condition Ulcerative Colitis
Treatment Placebo, Etrasimod
Clinical Study IdentifierNCT05061446
SponsorArena Pharmaceuticals
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Japanese ancestry
Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
Having active UC confirmed by endoscopy
Moderately to severely active UC

Exclusion Criteria

Severe extensive colitis
Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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