An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With an 18-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)

Trial Profile

An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With an 18-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Seladelpar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors CymaBay Therapeutics
  • Most Recent Events

    • 10 Aug 2017 According to a CymaBay Therapeutics media release, this trial will support dose selection for Phase 3 trial.
    • 17 Jul 2017 According to a CymaBay Therapeutics media release, the FDA has agreed to allow continuation of seladelpar treatment beyond six months for the 5 mg and 10 mg doses based on the results of this trial.
    • 17 Jul 2017 Interim results (n = 24) published in a CymaBay Therapeutics media release.
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