Of all people who have PBC, 90% are female and 10% are male. Diagnosis typically occurs between 40 and 60 years of age1
Up to 40% of patients who take the most commonly prescribed medication for PBC do not respond to it, and 5-10% of patients are not able to tolerate it2
ELATIVE Clinical study
ELATIVE is a Phase 3 clinical study evaluating the effects of elafibranor3 in patients with PBC
Participate in the study
Please speak with your healthcare team, family, and study staff to help decide if participating in the ELATIVE study is right for you.
What is a clinical study ?
A clinical study (also known as a clinical trial) is designed to evaluate how safe and/or effective an investigational drug is in treating a specific condition. Regulatory authorities use the results of clinical studies to decide if an investigational drug is safe and effective and could be made available to more patients. Clinical studies are the only way we can develop new or better medical treatments and improve patient care.
Every clinical study is reviewed by an Independent Review Board/Ethics Committee that helps ensure the study is conducted safely, and that the rights of participants are protected. Clinical studies are conducted by experienced and trained medical professionals who monitor the health of participants throughout the study.
What is Primary Biliary Cholangitis (PBC) ?
PBC is a rare autoimmune disease of the liver that affects all aspects of life and has no cure. PBC causes the body’s immune system to mistakenly attack the small bile ducts in the liver. This causes them to become inflamed and damaged over time.
The damaged bile ducts are not able to carry bile out of the liver, causing a buildup of bile. Over time this leads to scarring (cirrhosis) and damage to the liver. Although a patient may not have noticeable symptoms, if left untreated PBC may eventually cause liver failure. Of all people who have PBC, 90% are female and 10% are male. Diagnosis typically occurs between 40 and 60 years of age.1
Why is the ELATIVE study being conducted ?
Although there are medications available that can help people manage PBC and slow the worsening of the disease, there remains a need for new and alternative treatments. Up to 40% of patients who take the most commonly prescribed medication for PBC do not respond to it, and 5-10% of patients are not able to tolerate it.2 For these reasons, more research is needed to help discover new PBC treatment options.
What is the purpose of the ELATIVE study ?
The main objective of this study is to evaluate the effects of an investigational drug called elafibranor in patients with PBC. In an earlier 12-week study with a similar patient population, elafibranor was generally well-tolerated (compared to placebo) and patients taking it showed improvements in PBC lab tests, and trends for improvement in itching (pruritus). This study will provide information on how the drug may work in more patients over at least one year.
What happens in the ELATIVE study ?
The study involves about 150 participants at research clinics all over the world. The main part of the study lasts up to 2 years. Participants may then receive elafibranor for up to 5 more years. The study is divided into 3 main periods:
- Screening Period (2 to 12 weeks): Tests will be done and your medical history will be reviewed to see if you qualify for the study.
- Double Blind Period (1 to 2 years): If you qualify for and join the study, you will be randomly assigned to study treatment with either elafibranor or placebo. You will not know if you are taking elafibranor or placebo. Placebo looks like the investigational drug but contains no active ingredient. You will have a 2 in 3 (67%) chance of receiving elafibranor. You will take your assigned study treatment every day (as one tablet taken with water) and come to the research clinic about 8 times for testing and to check on your health.
- Long Term Extension (up to 5 years): If you continue in the study after the Double Blind Period, you will receive elafibranor regardless of the study treatment you received during the Double Blind Period. You will come to the research clinic about every 6 months during this period for testing and to check on your health. Throughout the study you will complete questionnaires about your PBC symptoms and how they make you act and feel. During the first year of the study you will do this using a handheld electronic diary (like a smartphone) each evening.
What is elafibranor ?
Elafibranor is an investigational drug. It is not approved by any regulatory authority.
It is thought to act by reducing inflammation and the toxic effects of bile in your liver.
Who can participate in the ELATIVE study ?
You may be able to participate if you:
- Are 18 to 75 years old
- Have been diagnosed with PBC
- Have been taking ursodeoxycholic acid (UDCA or Ursodiol) for at least 1 year but did not meet treatment goals,
or tried taking it but stopped due to side effects
- Have not had a liver transplant and/or are not currently on a liver transplant list
Other criteria will be reviewed to determine if you may participate in the study.
Will the ELATIVE study cost me anything ?
The study drug and all study-related tests and procedures will be provided at no cost to participants.
Personalized service, including travel support, may be offered.
Reimbursement for ursodeoxycholic acid used during study participation may be provided
Why participate in a clinical research study ?
There are several reasons to participate in the study:
- You will receive study-related care from specialized medical professionals
- You may learn more about your PBC and your health
- Your participation may help advance the research of treatments for PBC
Not everyone enrolled in the study will benefit directly. Your health may improve or may not improve at all.
It is also possible that some participants may feel worse. Taking part in a clinical study is completely voluntary.
If enrolled, you can choose to end your participation at any time and for any reason.
- Boonstra, K., U. Beuers, and C.Y. Ponsioen, Epidemiology of primary sclerosing cholangitis and primary biliary cirrhosis: a systematic review. J Hepatol, 2012. 56(5): p. 1181-8
- Ali, A., et al., Orphan drugs in development for primary biliary cirrhosis: challenges and progress. 2015. 5: p. 83-97.
- Elafibranor is an investigational compound and has not been approved by any regulatory authority for any indication.