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A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

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Trial Profile

A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Sep 2022

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At a glance

  • Drugs EDP 305 (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Therapeutic Use
  • Acronyms INTREPID
  • Sponsors Enanta Pharmaceuticals

    • Most Recent Events

    • 05 Jun 2020 Status changed from active, no longer recruiting to completed.
    • 06 May 2020 Primary endpoint has not been met. (Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12)
    • 06 May 2020 According to an Enanta Pharmaceuticals media release, Clinical Professor, Elson S. Floyd College of Medicine, Washington State University, the Principal Investigator for the study
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