An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Oct 4, 2024
  • participants needed
    702
  • sponsor
    Arena Pharmaceuticals
Updated on 4 November 2020

Summary

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blinded treatment (either etrasimod 2 mg per day or placebo) during participation in one of two Phase 3 double-blinded, placebo-controlled studies (either Study APD334-301 or APD334-302).

Details
Treatment Etrasimod
Clinical Study IdentifierNCT03950232
SponsorArena Pharmaceuticals
Last Modified on4 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 16 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Ulcerative Colitis or Ulcerative Colitis (Pediatric)?
Must have met the eligibility criteria and have been enrolled in one of the two parent studies (APD334-301 or APD334-302) and also meet the following additional criteria
Participants previously enrolled in Study APD334-301 must have completed the Week 12 visit and have been assessed to have active UC that had deteriorated from baseline or completed the Week 52 visit
Participants previously enrolled in APD334 302 must have completed the Week 12 visit

Exclusion Criteria

If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
Experienced an adverse event that led to discontinuation from one of the parent studies
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Step 3 Enroll in the clinical study

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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Step 4 Get your study results

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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