Purpose of this Study
In this study, people will take part for about five years. They will be placed into one of two groups by chance. One group will receive a medicine called elafibranor, and the other group will receive a placebo, which has no active medicine. The medicine is taken by mouth.
During the study, participants will have many clinic visits for tests and checkups. These may include blood tests, liver biopsies, ultrasound scans, and questionnaires about how they feel.
The medicine works by acting on parts of the body, especially the liver, to help reduce swelling and improve how bile moves. Researchers want to learn if this medicine is safe and if it can help improve liver health.
Who Can Participate?
Eligibility
People can join this study if they have a liver disease called primary sclerosing cholangitis that affects the bile ducts. Their doctors must have shown this disease with special scans and blood tests that measure liver health. Their test results must show certain levels that mean the disease is active but not too severe.
Participants may need to have a liver biopsy, which is a small sample taken from the liver, if one was not done recently. Some people may already be taking a medicine for this condition, and if they are, the dose must be stable for a few months before joining the study.
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to learn more about a rare disease called primary sclerosing cholangitis. This disease causes swelling and scarring in the tubes that carry bile from the liver. Researchers want to study a medicine called elafibranor to see how it works over a long time. They will look at both the benefits and the risks of using this medicine again and again. The goal is to learn if this treatment can help patients and improve liver health over time.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate theEfficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis
Principal Investigator
Matthew
Kappus
Protocol Number
PRO00120710
NCT ID
NCT07387549
Phase
III
Enrollment Status
Pending Open to Enrollment