An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis (ELEVATE UC OLE)

  • End date
    Aug 13, 2027
  • participants needed
  • sponsor
    Arena Pharmaceuticals
Updated on 13 October 2022
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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-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

Condition Ulcerative Colitis
Treatment Etrasimod
Clinical Study IdentifierNCT03950232
SponsorArena Pharmaceuticals
Last Modified on13 October 2022


Yes No Not Sure

Inclusion Criteria

Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies and meet the following additional criteria
Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
Participants previously enrolled in APD334-302 (NCT03996369) 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 parent study
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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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