Elafibranor for Primary Biliary Cholangitis

(ELATIVE Trial)

Recruiting at114 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Ipsen

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a drug called elafibranor on patients with Primary Biliary Cholangitis (PBC) who haven't responded to standard treatment. The goal is to see if elafibranor can lower a specific liver enzyme and improve symptoms. Initially, participants will receive different treatments, and later, all will receive elafibranor for an extended period. Elafibranor has shown promise in improving symptoms in previous trials.

Research Team

Ipsen Medical Director

Principal Investigator

Ipsen

Eligibility Criteria

This trial is for adults aged 18-75 with Primary Biliary Cholangitis (PBC) who haven't responded well to or can't tolerate Ursodeoxycholic Acid. They must have a certain level of ALP enzyme and be using effective contraception if applicable. Exclusions include HIV, pregnancy, alcohol abuse, previous Elafibranor use, certain liver conditions, high levels of liver enzymes or bilirubin, low albumin or abnormal blood clotting.

Inclusion Criteria

I have been diagnosed with primary biliary cholangitis.

I have been on UDCA for 12 months or can't tolerate it.

I am either unable to have children or will use effective birth control during and for 1 month after the study.

Exclusion Criteria

I do not have any health conditions, including other cancers, that could shorten my life to under 2 years.

Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5x ULN

Serum creatinine > 1.5 mg/dL

Treatment Details

Interventions

• Elafibranor 80mg (PPAR agonist)
• Placebo (Drug)

Trial Overview The study tests the effects of daily oral Elafibranor (80mg) versus placebo on bile flow impairment in PBC patients intolerant or unresponsive to standard treatment. Participants are randomly assigned in a 2:1 ratio to receive either Elafibranor or placebo.

Participant Groups

Group I: Elafibranor 80mg open label Experimental Treatment 1 Intervention

Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning

Group II: Elafibranor 80mg double-blind Experimental Treatment 1 Intervention

Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning

Group III: Placebo Placebo Group 1 Intervention

Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

Genfit

Lead Sponsor

Trials

20

Recruited

3,500+