Safety and Effectiveness of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis
Research type
Research Study
Full title
A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)
IRAS ID
1006826
Contact name
Douglas Thorburn
Contact email
Sponsor organisation
Ipsen Bioscience, Inc.
Eudract number
2022-002695-37
Research summary
This research study is to see how well Elafibranor works for the treatment of primary sclerosing cholangitis (PSC), compared to placebo, and to see if it is safe in adult participants with PSC.
PSC occurs because of inflammation in the bile ducts (cholangitis), which results in hardening (sclerosis) and narrowing of the ducts. As a result, bile cannot be released properly, and it builds up in the liver and if it stays there for too long it can hurt your liver. Eventually this can lead to cirrhosis (advanced liver damage) and its associated complications, as scar tissue replaces healthy liver tissue and liver function becomes increasingly reduced, also called end-stage liver disease. When a person has end-stage liver disease, a liver transplant may be needed. PSC can affect men and women at any age, however it is commonly diagnosed between the ages of 30 and 40, most often in the presence of inflammatory bowel disease (IBD). There is currently no curative treatment for PSC.
In this study, participants will receive the study drug as two tablets each day, and they will be in the study for up to 120 weeks. There will be tests and procedures as part of this study including physical exams, clinical evaluations, blood and urine tests, electrocardiograms (ECG), ultrasound exams, FibroScan® exams and questionnaires.REC name
London - Central Research Ethics Committee
REC reference
23/LO/0074
Date of REC Opinion
5 Oct 2023
REC opinion
Further Information Favourable Opinion