Study of Elafibranor in Adults with PBC & Inadequate Response/Intolerance to Ursodeoxycholic Acid
Research type
Research Study
Full title
A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants with Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid
IRAS ID
1010311
Contact name
Lynsey Corless
Contact email
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to learn about a drug called elafibranor, it is an oral drug that activates specific receptors in the human body, particularly in the liver. Activation of these receptors is thought to have different effects, including reducing inflammation & improving composition & flow of bile acids. Based on this mechanism of action, it is expected that elafibranor may provide benefit to patients with Primary Biliary Cholangitis (PBC). PBC occurs due to inflammation & injury of small bile ducts in the liver (cholangitis). Rate of disease progression varies in individual patients, but generally progression is faster in patients who are inadequate responders to existing therapies, or who do not receive medical therapy. Disease progression can lead to liver failure & there is currently no cure for PBC.
The study will help assess if elafibranor will improve symptoms & help normalise alkaline phosphatase levels (ALP), an enzyme released by the liver, bones & other tissues linked to inflammation & injury of the liver, in adults with PBC, who have not adequately responded or who were intolerant to Ursodeoxycholic Acid (UDCA), a medication used in the management & treatment of cholestatic liver disease. Participants taking UDCA should have been on this medication for at least 6 months and at a stable dose for ≥3 months prior to screening. Participants not taking UDCA or intolerant to UDCA may participate & should have taken the last dose of UDCA ≥3 months prior to screening. The study will also test if elafibranor is safe & well tolerated.
Participants will receive one tablet each day, taken orally every morning for a max of 52 weeks (1 year). In total, participants will be followed for up to 64 weeks (approximately 15 months). The study is double-blinded & randomised but participants will be twice as likely to receive study drug as placebo.
Participants must be over 18 years of age with a diagnosis of PBC & a defined level of ALP in the blood.REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0534
Date of REC Opinion
29 Oct 2024
REC opinion
Further Information Favourable Opinion