What is elafibranor studying for Primary Biliary Cholangitis (PBC)?

Elafibranor is being studied to see if it can prevent worsening of Primary Biliary Cholangitis, including the need for liver transplant or death. The trial also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Ipsen sponsors this research to improve understanding of PBC treatment options.

Who may be eligible for this Primary Biliary Cholangitis clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of Primary Biliary Cholangitis and cirrhosis classified as Child Pugh A or B may be eligible. Both men and women can join if they meet contraception requirements and do not have other liver diseases or serious health conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this Primary Biliary Cholangitis clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06016842

A Phase III Study Evaluating Elafibranor 80 mg for Long-Term Outcomes in Adults With Primary Biliary Cholangitis PBC

Led by Ipsen · Updated on 2026-06-01

276

Participants Needed

183

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of elafibranor in adults with Primary Biliary Cholangitis PBC who also have cirrhosis, a serious liver condition involving scarring. PBC is a slowly progressing disease that damages bile ducts, causing bile acids to build up and harm the liver further. This study aims to see if elafibranor can better prevent worsening of the disease, including the need for liver transplant or death, compared to a placebo. The safety of long-term use and effects on symptoms like itching and tiredness will also be assessed. Participants will be randomly assigned to take either one 80 mg tablet of elafibranor or a matching placebo tablet once daily, taken orally with or without food, at about the same time each morning. The treatment period can last up to 3.5 years in a double-blind setting, meaning neither participants nor researchers know who receives the drug or placebo. This design allows a direct comparison of elafibranors impact on disease progression and safety over a long term. Throughout the study, participants will undergo regular assessments including blood tests, physical exams, vital signs, ECGs, and liver imaging to monitor liver function and stiffness. Researchers will track a range of outcomes such as survival without clinical events, changes in liver and blood markers, symptom severity, and quality of life measures. Safety monitoring will continue until 4 weeks after the last dose. Each participant may be involved for up to 3.5 years from baseline to final evaluation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female participants aged 18 years or older at informed consent
Definite or probable diagnosis of Primary Biliary Cholangitis (PBC)
Presence of cirrhosis at screening visit
Classified as Child Pugh A or Child Pugh B
Use of contraception consistent with local regulations for study participation
Ability to provide signed informed consent and comply with study requirements

You will not qualify if you...

Presence of other liver diseases such as Primary Sclerosing Cholangitis, Autoimmune Hepatitis, Hepatitis B or C, Alcohol-associated liver disease, Nonalcoholic steatohepatitis, or alpha-1 antitrypsin deficiency
History or presence of significant liver complications including previous liver transplant, current transplant listing, high MELD score, uncontrolled ascites, variceal bleeding, hepatic encephalopathy grade 2 or higher, spontaneous bacterial peritonitis, or hepatorenal syndrome
Hospitalization for liver-related complication within 12 weeks prior to screening
Known HIV infection
Medical conditions causing non-hepatic alkaline phosphatase elevation
Unstable or untreated significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric diseases
Non-hepatic conditions reducing life expectancy to less than 2 years, including cancers
History of hepatocellular carcinoma or positive imaging suggesting it
Malignancy within the last 5 years except certain treated skin or in situ cancers
Recent use of prohibited medications including fibrates, certain immunosuppressants, corticosteroids, and potentially hepatotoxic drugs
Participation in another investigational drug or device study within 30 days or 5 half-lives, with some exceptions for prior PBC therapies
Electrocardiogram findings with prolonged QTc interval beyond set limits
Laboratory abnormalities such as bilirubin greater than 5 times upper limit, ALT or AST over 5 times upper limit, elevated creatinine phosphokinase, low platelet count, elevated INR without anticoagulation, reduced kidney function, or significant renal disease
Current pregnancy, positive pregnancy test, or breastfeeding
Unwillingness or inability to abstain from alcohol during the study
History of alcohol or substance abuse within 1 year prior to screening
Known hypersensitivity to elafibranor or its excipients
Mental instability or inability to provide valid informed consent or comply with study
Any condition that may interfere with study participation or increase risk
Alkaline phosphatase greater than 10 times upper limit
Albumin less than 2.8 g/dL due to liver impairment

Research Team

Ipsen Clinical Study Enquiries

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