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

To join this study, you need to be an adult aged 18 or over. You must have a confirmed diagnosis of PBC, which means your doctor has previously identified specific signs of the disease, like unusual ALP blood levels for at least six months, certain positive antibody tests, or a liver biopsy showing PBC. Crucially, your current PBC treatment (UDCA) must either not be working effectively for you (meaning your current ALP levels are still high) or you must be unable to take UDCA due to side effects. If you're on UDCA, your dose needs to have been stable for at least three months, and if you can't take UDCA, it should have been at least three months since your last dose. If you're taking medication for itching related to PBC, its dose also needs to be stable for three months.

There are also some reasons why you might not be able to join. For example, if you have other serious liver diseases, or if your PBC has progressed to a very advanced stage of liver scarring (cirrhosis) that is causing significant issues (Child-Pugh B or C). You also can't participate if you've had a liver transplant, have HIV, or have other medical conditions that might interfere with the study results or your safety. The study team will review all your medical information carefully to make sure it's safe and appropriate for you to take part.

If you decide to join this study, your involvement will be split into three main parts, lasting up to 15 months in total. First, there's a 'screening period' of up to 8 weeks, where doctors will carry out tests to make sure the study is right for you. Next is the 'treatment period,' which lasts up to 52 weeks. During this time, you'll be randomly assigned to either receive the study drug, elafibranor, or a placebo (a dummy treatment) daily. You'll have a two-in-three chance of receiving elafibranor. Finally, there's a 'follow-up period' of 4 weeks, where your health will continue to be monitored after you've stopped taking the study medication.

Throughout the study, you'll have regular visits where various checks will be performed. These include blood tests and urine samples, physical examinations, and general health check-ups. You'll also have an ECG (a heart tracing), an ultrasound (a scan of your liver and other organs), and a special Fibroscan® to measure your liver stiffness. Additionally, you'll be asked to fill in some questionnaires about your health and how you're feeling.