A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Status:
Recruiting
Trial end date:
2030-10-18
Target enrollment:
Participant gender:
Summary
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC).
Participants will also have inadequate response or intolerance to ursodeoxycholic acid (UDCA)
a drug used to treat 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 up to about 7 years.
The main aim of this study is to determine if elafibranor is better than placebo in
preventing clinical outcome events showing disease worsening (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.