A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

Conditions

• Primary Biliary Cholangitis (PBC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elafibranor — DRUG
  Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which elafibranor 80 mg tablet will be administered once daily
• Matched 80 mg placebo — OTHER
  Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which matching placebo tablet will be administered once daily

Study Details

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

Key Dates

Start date

Aug 31, 2023

Status verified

May 2026

Primary completion

May 31, 2029

Completion

May 31, 2029

Study Design

Enrollment

276 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elafibranor 80 mg
  Participants will take 1 tablet of elafibranor 80 mg per day orally with a glass of water at approximately the same time each morning, with or without food.
• Placebo Comparator: Placebo
  Participants will take 1 placebo tablet per day orally (matching the 80 mg elafibranor sized tablet) with a glass of water at approximately the same time each morning, with or without food.

Primary Outcome Measure

Event-free survival [ Time Frame: From baseline until 4 weeks after the last dose of study intervention (maximum duration of 3.5 years) ]

Central Contacts

• Ipsen Clinical Study Enquiries
  See e mail
  [email protected]

Locations (40)

Find similar trials in Tucson, AZ

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