Elafibranor Advances to Phase 3 Clinical Trial for Treatment of PSC
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On February 4, 2026, the initial study details for Ipsen’s Phase 3 ELASCOPE clinical trial for elafibranor for treatment of PSC were listed on ClinicalTrials.gov. Study enrollment is anticipated to start around April 2026 and key details of the study design are now available.
“PSC Partners is thrilled to see Ipsen move forward with this global Phase III study,” said Ricky Safer, Founder and CEO of PSC Partners. “This is a key step forward in fulfilling our mission of finding a cure for PSC. We are grateful to Ipsen for their commitment to those affected by PSC and to all patients whose prior participation in research have made this milestone study possible.”
“Ipsen is honored to have launched a Phase III clinical study for people living with PSC,” added Jennifer Schranz, Senior Vice President, Global Head of Rare Diseases at Ipsen. “We are deeply committed to advancing potential treatments for rare liver diseases where there is a significant unmet need and few options for patients currently exist.”
Below is a summary of elafibranor and the pivotal global Phase III study:
About Elafibranor:
Elafibranor is a PPARα/δ agonist taken as an oral pill which can potentially treat PSC by decreasing bile acid synthesis and toxicity, increasing bile acid secretion, and decreasing inflammation. Together, these effects may lessen damage caused by cholestasis in PSC. The Phase 2 study of elafibranor in PSC (the ELMWOOD trial) showed dose-dependent reductions in ALP and other markers of liver injury and fibrosis, as well as a favorable safety profile.
Elafibranor is already approved by regulatory agencies for treatment of primary biliary cholangitis (PBC) as a second-line treatment when UDCA (Urso) is not effective for a patient.
Study Details:
The ELASCOPE trial anticipates enrolling 350 patients across approximately 200 sites globally. The study will be open to adults with large duct PSC and no history of liver transplant or decompensated cirrhosis (complications associated with advanced disease). Patients will be randomly assigned to receive elafibranor or a placebo.
Concurrent UDCA usage is allowed, along with most other stable ongoing treatments. Medications that are NOT concurrently allowed include, but are not limited to: norucholic acid, fibrates, seladelpar, and glitazones.
Study participation is expected to last up to five years to collect sufficient outcomes data (events associated with disease progression) to allow for effective comparison of the group receiving elafibranor to the placebo/control group.
For more information, including inclusion and exclusion criteria, please visit the study listing on ClinicalTrials.gov.
PSC Partners is encouraged by the news of elafibranor advancing to Phase 3, the critical study phase to determine whether a drug will receive market approval by the FDA and other regulatory agencies. We will continue to share more information about this study as it becomes available.