EDP-305 in Primary Biliary Cholangitis

Condition: Primary biliary cholangitis

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Primary biliary cholangitis by at least two of the following criteria:
    • History of alkaline phosphatase above upper limit of normal (ULN) for at least 6 months
    • Positive anti-mitochondrial antibodies titers
    • Documented liver biopsy result consistent with primary biliary cholangitis (with no cirrhosis)

Key Exclusion Criteria

  • Laboratory screening results:
    • Aspartate aminotransferase >5 ULN
    • Alanine aminotransferase >5 ULN
    • Total bilirubin >1.8 mg/dL

Full Study Name

A Phase II 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) (EDP 305-201) (IRB no. 51086)

Summary

The purpose of this study is to evaluate whether an investigational drug called EDP-305 is safe and effective for individuals with primary biliary cholangitis (PBC), a chronic disease of the liver, in patients with or without an inadequate response to ursodiol therapy. Researchers also aim to determine the dose of study drug that works best. The study will compare the effects of EDP-305 against the effects of a placebo (inactive substance). Samples for biomarkers will also be collected. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. Biomarkers can be helpful in evaluating the effectiveness and safety of a medicine. Participants will be randomly assigned to receive EDP-305 or placebo.

Phase

Phase II

Principal Investigator

Walid Ayoub, MD

Contact
Kelly Delarosa
Phone: 310-423-2743
Email: kelly.delarosa@cshs.org