Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)

Conditions

• Primary Biliary Cirrhosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Elafibranor 80mg — DRUG
  Elafibranor 80mg daily
• Placebo — DRUG
  Placebo daily

Study Details

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (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. The main aim of this study is to determine if elafibranor (the study drug) is better than placebo (a dummy treatment) at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also evaluate the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itchy skin (pruritus) and tiredness (fatigue). This study has two main parts: Part 1 will compare a daily dose of elafibranor to a daily dose of placebo and will last between a minimum of one year and a maximum of two years. Part 2, all participants will receive elafibranor for a period of up to 5 years or until the total treatment duration (part 1 and part 2) reaches 6 years, whichever occurs first.

Key Dates

Start date

Sep 24, 2020

Status verified

May 2026

Primary completion

Jun 1, 2023

Completion

Dec 1, 2028

Study Design

Enrollment

161 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elafibranor 80mg double-blind
  Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning
• Placebo Comparator: Placebo
  Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning
• Experimental: Elafibranor 80mg open label
  Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning

Primary Outcome Measure

Percentage of Participants With Response to Treatment Based on Cholestasis Response at Week 52 [ Time Frame: At Week 52 ]

Locations (46)

Find similar trials in Chandler, AZ

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