A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.

Exclusion Criteria

• •History or presence of other concomitant liver diseases.
• •Participants with known cirrhosis who have a Child-Pugh B or C score. Participants with cirrhosis with Child-Pugh A score are allowed.
• •History of liver transplantation.
• •History or presence of clinically significant hepatic decompensation.
• •Known history of human immunodeficiency virus (HIV) infection.
• •Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
• •Evidence of any other unstable or untreated clinically significant conditions that are not well controlled.
• •Medical condition with a life expectancy \<2 years.
• •Known malignancy or history of malignancy within the last 2 years, except for successfully treated localised basal cell carcinoma or squamous cell carcinoma of the skin; or in-situ carcinoma of the uterine cervix.
• •History of hepatocellular carcinoma.
• •Alpha-foetoprotein (AFP) \>20 ng/mL with 4-phase liver computed tomography (CT) or magnetic resonance imaging (MRI) scans suggesting presence of liver cancer.
• •Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below:
• •\* i. Systemic (oral or parenteral) use within 3 months prior to SV1 of: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, or long-term systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, valproic acid, isoniazid or nitrofurantoin)
• •Participants with previous exposure to elafibranor.
• •Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer.
• •Total bilirubin (TB) \>2 × ULN. Participants with Gilbert's syndrome are eligible with a TB above 2 × ULN if direct bilirubin is \<30% of TB.
• •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5 × ULN.
• •Creatine phosphokinase (CPK) \>2 × ULN.
• •Platelet count \<75,000/µL.
• •International normalised ratio \>1.3 in the absence of anticoagulant therapy.
• •Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2.
• •Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
• •Other exclusions
• •For female participants: known pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
• •Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women.
• •History of alcohol abuse, or other substance abuse within 1 year prior.
• •Known hypersensitivity to the investigational product or to any of the excipients of elafibranor.
• •Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
• •Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.