Elafibranor for Primary Sclerosing Cholangitis

(ELMWOOD Trial)

Recruiting at64 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ipsen

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing elafibranor, a medication, in people with Primary Sclerosing Cholangitis (PSC), a rare liver disease. PSC causes bile ducts to get damaged, leading to more liver problems. The study will evaluate if elafibranor is safe and effective in reducing liver inflammation and improving bile flow.

Research Team

Ipsen Medical, Director

Principal Investigator

Ipsen

Eligibility Criteria

Adults with Primary Sclerosing Cholangitis (PSC) can join this trial. They must have stable Inflammatory Bowel Disease if present, no recent severe liver issues or cancer, and be on a steady dose of certain medications like ursodeoxycholic acid. Participants need to use approved contraception methods and not be pregnant or breastfeeding.

Inclusion Criteria

I have been diagnosed with PSC and have had high ALP levels for over 6 months.

Exclusion Criteria

I have previously taken elafibranor.

I have a history of chronic liver disease or specific liver conditions.

I have had serious liver problems as outlined in the study.

Treatment Details

Interventions

• Elafibranor (PPAR agonist)
• Placebo (Drug)

Trial Overview The trial is testing Elafibranor at two different doses (80 mg and 120 mg) against placebos matched for each dose. The goal is to see how safe Elafibranor is and how well it works in treating PSC by comparing its effects on liver function tests and other disease-related measures.

Participant Groups

Group I: Open-Label Extension Period: Elafibranor 120 mg Experimental Treatment 1 Intervention

Participant will receive one tablet per day (elafibranor 120 mg) over the 96 weeks in Open-Label extension period.

Group II: Double-Blind Period: Elafibranor 80 mg Experimental Treatment 2 Interventions

Participant will receive two tablets per day (one tablet of elafibranor 80 mg + 1 tablet of placebo matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.

Group III: Double-Blind Period: Elafibranor 120 mg Experimental Treatment 2 Interventions

Participant will receive 2 tablets per day (one tablet of elafibranor 120 mg + 1 tablet of placebo matching the 80 mg sized tablet) over the 12 weeks in Double-blind period.

Group IV: Double-Blind Period: Placebo Placebo Group 1 Intervention

Participant will receive 2 placebo tablets per day (one matching the 80 mg sized tablet + one matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.

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