Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC
Research type
Research Study
Full title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid.
IRAS ID
221507
Contact name
David Emrys Jeffreys Jones
Contact email
Sponsor organisation
GENFIT
Eudract number
2016-003817-80
Clinicaltrials.gov Identifier
IND, 132202
Duration of Study in the UK
0 years, 10 months, 3 days
Research summary
The purpose of this research study is to learn more about the effectiveness and safety of an experimental drug called Elafibranor in the treatment of a type of liver disease known as Primary Biliary Cholangitis (PBC). \n\nPBC is a rare chronic liver disease resulting from progressive destruction of bile ducts in the liver. When the ducts are destroyed, bile builds up in the liver contributing to inflammation which leads to liver scarring. \n\nThere is no cure for PBC and it can eventually lead to cirrhosis, When a person has end-stage liver disease, a liver transplant is necessary to avoid death. PBC is also a risk factor for hepatocellular carcinoma (a type of liver cancer). Despite its rarity, PBC remains an important cause of morbidity in the Western world. \n\nThe study will determine the effect that Elafibranor has on serum Alkaline Phosphatase (a protein found in the body that is routinely used to monitor PBC) in patients who have had an inadequate response to Ursodeoxycholic Acid (drug currently used for PBC patients).\n\nThe effectiveness and safety of different doses of Elafibranor will be measured(80 mg and 120 mg) as well as comparing its effect to a placebo (substance given to a patient like a drug but has no physical effect on the patient). \n\n\nThe study includes a treatment period of 12 weeks for eligible adults with PBC. A computer will randomly assign participants to different treatment groups in the study. \n\nIt will take place in the UK, Germany and Spain as well as the United States of America and will include 45 participants.\n\nThroughout the study, participants will have study visits for safety monitoring and additional examinations (including blood samplings) which will be conducted to better understand Elafibranor.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0078
Date of REC Opinion
26 May 2017
REC opinion
Further Information Favourable Opinion