A Double-Blind Randomized Placebo-Controlled Study and Open-Label Long Term Extension of study drug in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Primary Biliary Cholangitis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Male and female subjects, ages 18 to 75 years and able to provide written informed consent and agree to comply with the study protocol
    2. Definite or probable Primary Biliary Cholangitis (PBC) diagnosis
    3. Subjects who agree to have and it is safe and practical to proceed with a liver biopsy
    4. Must have at least 4 available values for PBC Worst Itch Numeric Rating Scale (NRS)
    5. Ursodeoxycholic acid (UDCA)for at least 12 months (stable dose = 3 months) prior to randomization, or unable to tolerate UDCA treatment (no UDCA for = 3 months) prior to randomization (per country standard-of-care dosing)
    6. If on colchicine must be on a stable dose for = 3 months prior to randomization
    7. Medications for management of pruritus (e.g., cholestyramine, rifampin, naltrexone or sertraline) must be on a stable dose for = 3 months prior to randomization
    8. If taking statins or ezetimibe must be on a stable dose for = 2 months prior to randomization
    9. Female subjects of childbearing potential and male subjects with a pregnant or a non-pregnant partner of childbearing potential must agree to use highly effective method of contraception

You may not be eligible for this study if the following are true:

    1. History or presence of other concomitant liver disease
    2. Clinically significant hepatic decompensation
    3. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget’s disease) or which may diminish life expectancy to < 2 years, including known cancers
    4. Positive test for Human Immunodeficiency Virus (HIV) Type 1 or 2 at screening, or patient is known to have tested positive for HIV
    5. Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator
    6. Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study
    7. History of alcohol abuse, defined as consumption of more than 30 g pure alcohol per day for men, and more than 20 g pure alcohol per day for women, or other substance abuse within 1 year prior to screening visit (SV1)
    8. Pregnant, positive pregnancy test or lactating
    9. Administration of the following medications are prohibited as specified below:
      • 2 months prior to randomization and throughout the study (up to the last study visit): fibrates and glitazones
      • 3 months prior to randomization and throughout the study (up to the last study visit): Obeticholic acid (OCA), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids; potentially hepatotoxic drugs
      • 12 months prior to randomization and throughout the study (up to the last study visit): antibodies or immunotherapy directed against interleukins (ILs) or other cytokines or chemokines
    10. Participating in other investigational drug study
    11. Previous exposure to elafibranor
    12. Abnormal laboratory results
    13. Significant renal disease, including nephritic syndrome, chronic kidney disease

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