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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2024

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At a glance

  • Drugs Etrasimod (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ELEVATE UC 52
  • Sponsors Arena Pharmaceuticals

    • Most Recent Events

    • 19 Feb 2024 According to a Pfizer media release, the marketing authorization for VELSIPITY is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Regulatory applications for VELSIPITY in UC have been submitted to additional countries around the world for review.
    • 19 Feb 2024 According to a Pfizer media release, based on results from the ELEVATE UC 52 and ELEVATE UC 12, the European Commission has granted marketing authorization for VELSIPITY in the EU to treat patients 16 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
    • 17 Oct 2023 Results of a post hoc analysis of daily e-diary data collected on rectal bleeding and stool frequency from patients enrolled in ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) presented at the 31st United European Gastroenterology Week
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