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A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

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Trial Profile

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Apr 2026

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At a glance

  • Drugs Elafibranor (Primary)
  • Indications Primary sclerosing cholangitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ELASCOPE
  • Sponsors Ipsen

Most Recent Events

  • 06 Apr 2026 Planned initiation date changed from 14 Apr 2026 to 30 Apr 2026.
  • 26 Feb 2026 According to Genfit media release, the company has confirmed initiation of the first and only global Phase 3 clinical trial in Primary Sclerosing Cholangitis.
  • 09 Feb 2026 New trial record

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