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IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 Study Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

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Trial Profile

IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 Study Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 May 2025

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At a glance

  • Drugs Seladelpar (Primary)
  • Indications Primary sclerosing cholangitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms IDEAL
  • Sponsors CymaBay Therapeutics; Gilead Sciences

Most Recent Events

  • 05 May 2025 Status changed from recruiting to active, no longer recruiting.
  • 24 Mar 2025 Planned number of patients changed from 150 to 90.
  • 24 Mar 2025 Planned End Date changed from 1 Dec 2025 to 1 Jun 2026.

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