A Long-Term Study of Elafibranor in Adult Participants with Primary Biliary Cholangitis

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC). Participants will also have inadequate response or intolerance to ursodeoxycholic acid (UDCA). UDCA is a medication used in the management and treatment of PBC. PBC is a disease that progresses slowly. It causes damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many people with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). Each participant will be in the study for about 7 years. The main aim of this study is to determine if elafibranor is better than placebo in preventing adverse (bad) clinical outcomes including progression of disease leading to liver transplant or death. This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

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