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RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

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RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Aug 2024

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At a glance

  • Drugs Seladelpar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RESPONSE
  • Sponsors CymaBay Therapeutics

    • Most Recent Events

    • 14 Aug 2024 According to Gilead Sciences media release, company announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA
    • 25 Jul 2024 Arms decreased from 3 to 2. Experimental arm Seladelpar 5 mg has been cancelled. Primary endpoints 'Percentage of Participants With TEAEs nd Serious TEAEs' and 'Percentage of Participants With Shift of greater and equals to 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry' added newly.
    • 05 Jun 2024 Interim results (n=158; data cutoff date: 31 Jan 2024) published in a Gilead Sciences Media Release

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