A clinical trial studying a potential treatment for primary biliary cholangitis (PBC) is scheduled to launch on July 1. The trial, sponsored by Ipsen, aims to assess the safety and efficacy of elafibranor in PBC.
Primary biliary cholangitis (PBC) is a chronic liver disease characterized by the progressive destruction of bile ducts caused by an inadequate immune system response toward healthy tissue. This leads to liver damage and potential scarring (fibrosis). Currently, ursodeoxycholic acid (UDCA) represents the standard of care for patients with PBC; however, an important percentage of patients do not adequately respond to treatment.
Therefore, investigators aimed to evaluate whether elafibranor can be a viable therapeutic alternative for patients with PBC. In the trial, dubbed ELSPIRE, patients diagnosed with PBC who are showing insufficient response or intolerance to treatment with UDCA will be randomized to receive either elafibranor or a placebo.
The primary goal of the study is to assess whether elafibranor can effectively reduce levels of Alkaline Phosphatase (ALP) in the blood, a marker of liver disease. The study spans three periods: screening (up to eight weeks), treatment (up to 52 weeks), and follow-up (four weeks), totaling 64 weeks of participation.
Twice as many participants will receive elafibranor compared to placebo, with various assessments conducted throughout the study, including blood sampling, urine collection, physical exams, and imaging tests like ultrasounds.
Participants will be asked to provide feedback through questionnaires, allowing researchers to gauge the medication’s impact on symptoms such as pruritus (itching). To assess the safety of the treatment adverse effects will be closely monitored and recorded.
Inclusion criteria for participants include historical diagnosis of PBC, elevated ALP levels and stable medication use. Exclusions encompass factors like advanced liver disease, certain medications and pregnancy will be assessed before beginning the study.
The study is expected to last over two years. It is estimated to start in July 2024 and complete in December 2026.
