A Phase 3 interventional study of Elafibranor and Matched 80 mg placebo in Primary Biliary Cholangitis (PBC), sponsored by Ipsen. Recruiting at 198 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Ipsen · Phase 3, Interventional, and Treatment
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.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's planned enrollment of 276 is above the median of 60 across 151 interventional studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Ipsen is the lead sponsor of 289 studies on the registry; 17 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 22 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
History or presence of other concomitant liver disease including but not limited to:
History or presence of hepatic decompensation, including:
Participants who are currently participating in, plan to participate in, or have participated in an drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.
i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Elafibranor
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.
Other: Matched 80 mg placebo
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
Duration: up to an estimated 42-month (3.5-year) double-blind treatment period during which matching placebo tablet will be administered once daily
Event-free survival
Event-free survival is defined as the time from randomisation to either adjudicated disease progression or death, whichever occurs first.
Time frame: From baseline until 4 weeks after the last dose of study intervention (maximum duration of 3.5 years)
Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs), treatment-related TEAEs, Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs)
An adverse event (AE) is any unfavourable medical occurrence in a trial participant administered the investigational product. The AE does not necessarily have a causal relationship with the treatment. AESIs are AEs that may or may not be serious but are of special importance to a particular drug or class of drugs.
Time frame: From baseline until 4 weeks after the last dose of study intervention (maximum duration of 3.5 years)
Percentage of participants developing clinically significant changes in physical examination findings
Complete physical examination at screening and targeted examination at all other clinical visit timepoints.
Time frame: From baseline until 4 weeks after the last dose of study intervention (maximum duration of 3.5 years)
Percentage of participants developing clinically significant changes in vital signs
Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be graded by the investigator.
Time frame: From baseline until 4 weeks after the last dose of study intervention (maximum duration of 3.5 years)
Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) readings.
Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be graded by the investigator.
Time frame: From baseline until 4 weeks after the last dose of study intervention (maximum duration of 3.5 years)
Percentage of participants with clinically significant changes in laboratory parameters (blood chemistry, hematology, coagulation and urinalysis)
Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be graded by the investigator.
Time frame: From baseline until 4 weeks after the last dose of study intervention (maximum duration of 3.5 years)
Change from baseline in Alkaline phosphatase (ALP)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in Total Bilirubin (TB)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with ALP≤ 1.67x ULN and TB≤ ULN
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with complete biochemical response
Defined as normal levels of TB, ALP, transaminases, albumin, and International normalised ratio (INR)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with normalisation of TB and ALP
Defined as TB\< Upper Limit Normal (ULN) and ALP\< ULN
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with stabilisation in TB (i.e. no increase)
Defined as TB\< 1x ULN or increase from baseline \<0.1x ULN
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with a response based on albumin normalisation
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in liver stiffness measurement (LSM)
Assessed by vibration-controlled transient elastography (VCTE) using Fibroscan® on the day of the visit.
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in PBC risk scores based in Global PBC Study Group (GLOBE) score
The GLOBE score is a validated risk assessment tool providing an estimate of transplant-free survival for patients with PBC. It was developed by the Global PBC Study Group using Cox regression model on over 4,000 patients with PBC. Lower GLOBE score predicts lower risk. It is calculated from the following equation: GLOBE score = (0.044378 \* age + 0.93982 \* LN(total bilirubin/ULN) +(0.335648 \* LN(alkaline phosphatase/ULN)) - 2.266708 \* albumin /LLN -0.002581 \* platelet count per 109/L) + 1.216865 GLOBE scoring system, which calculation is based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of treatment and age at baseline. A high number is indicative of a worse score.
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in PBC risk scores based on United Kingdom (UK)-PBC score.
PBC risk score developed by United Kingdom (UK)-PBC Consortium is a scoring system and the calculation is based on laboratory test measurements and upper limits of normal (ULN) for the total bilirubin (BIL12); alanine transaminase or aspartate transaminase (TA12), and alkaline phosphatase (ALP12) after at least 12 months of UDCA, and the laboratory test measurements and lower limits of normal (LLN) for the serum albumin and platelet count in the same timeframe. A high number is indicative of a worse score.
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with LSM ≥15 kPa
Assessed by VCTE using Fibroscan®
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change in serum levels of Aspartate aminotransferase (AST) compared to the baseline
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change in serum levels of ALT compared to the baseline
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change in serum levels of Gamma-glutamyl transferase (GGT) compared to the baseline
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in hepatic function: Conjugated (direct) bilirubin
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change in serum levels of Albumin compared to the baseline
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in hepatic function: international normalised ratio (INR)
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in hepatic function: fractionated ALP
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with no worsening of LSM
Assessed by VCTE using Fibroscan® defined as no increase \>2kPa from baseline
Time frame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with ALP reduction of 40%
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with ALP reduction >40% or ALP normalisation (Barcelona criteria)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with ALP <1.5x ULN, ALP decrease ≥15% and TB ≤ULN
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with ALP <1.5x ULN, ALP decrease ≥40% and TB ≤ULN
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with ALP <1.67x ULN, ALP decrease ≥15% and TB ≤ULN
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with ALP <3x ULN, AST <2x ULN and TB ≤1 mg/dL (Paris I)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with ALP ≤1.5x ULN, AST ≤1.5x ULN and TB ≤1 mg/dL (Paris II criteria)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with normalisation of abnormal TB
Time frame: Assessed at Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with normalisation of abnormal TB and albumin (Rotterdam criteria)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with TB ≤0.6× ULN in participants with TB >0.6× ULN at baseline
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in lipid parameters: total cholesterol (TC)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in lipid parameters: high density lipoprotein cholesterol (HDL-C)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in lipid parameters: calculated very low density lipoprotein cholesterol (VLDL-C)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in lipid parameters: low density lipoprotein cholesterol (LDL-C)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in lipid parameters: triglycerides (TG)
Time frame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with a response in PBC Worst Itch NRS score
Defined as ≥2-point reduction from baseline NRS in participants with a baseline NRS ≥4
Time frame: Through 6 months up to end of treatment (maximum duration of 3.5 years)
Percentage of participants with a response in PBC Worst Itch NRS
Defined as ≥3-point reduction from baseline NRS in participants with a baseline NRS ≥4
Time frame: Assessed through 6 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in 5D-Itch scale
Questionnaire that assesses symptoms in terms of 5 domains: degree, duration, direction, disability and distribution. Participants rate their symptoms over the preceding 2-week period on a 1 to 5 scale, with 5 being the most affected.
Time frame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in Patient Global Impression of Severity (PGI-S)
A 1-item, 5-point scale designed to assess the participant's impression of disease severity
Time frame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Patient Global Impression of Change (PGI-C)
A 1-item, 5-point scale designed to assess the participant's impression of change in disease severity since the baseline visit
Time frame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 7a
Consists of 7 items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week. Response options are on a 5-point Likert scale, ranging from 1 to 5. Scores can range from 7 to 35, with higher scores indicating greater fatigue.
Time frame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in the Epworth Sleepiness Scale (ESS)
Self-administered questionnaire that consists of 8 questions asking to rate how likely it is to fall asleep in different situations commonly encountered in daily life (each question can be scored from 0 to 3 points; '0' indicates no sleepiness, '3' indicates significant sleepiness). It provides a total score which has been shown to relate to the participant's level of daytime sleepiness (total score range 0-24 points).
Time frame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in PBC-40 score
40-item questionnaire that assesses symptoms across 6 domains: fatigue, emotional and social, cognitive function, general symptoms and itch. Participants respond on a verbal response scale, depending on the section options range from 'never' / 'not at all' / 'strongly disagree' to 'always' / 'very much' / 'strongly agree'. Six items (3/3 in the itch domain, 2/10 in the social domain, and 1/7 in the general symptoms domain) also include a 'does not apply' option. A score for each domain is provided (but a total score is not calculated), with each verbal response scale correlating to a score of 1 to 5 per item (0 to 5 on items with a 'does not apply' option) with 5 being the most affected (greatest burden). The PBC-40 has a 4-week recall period.
Time frame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score
Self-administered patient-reported outcome questionnaire that measures itch intensity. It asks participants to rate the intensity of their Worst Itch on an 11-point scale ranging from 0 (no itch) to 10 (Worst Itch imaginable): - once daily (24-hour recall period) using the eDiary during the screening and initial 2 years of the study, - at the clinic visits (7-day recall period), from Year 3 onwards
Time frame: Assessed through 6 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L)
Self-administered standardised questionnaire that assesses the 5-dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression descriptively (each dimension has 5 levels) and the overall health state via an EQ Visual Analogue Scale (VAS).
Time frame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Change from baseline in Work Productivity and Activity Impairment General Health (WPAI-GH)
Questionnaire that measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. It consists of 6 questions: 1=currently employed; 2=hours missed because of health problems; 3=hours missed because of other reasons; 4=hours actually worked; 5=degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6=degree health affected productivity in regular unpaid activities (VAS).
Time frame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
Time to the first occurrence of each of individual adjudicated clinical outcome events
Among: • All-cause mortality • Liver-related mortality • Liver transplant • MELD-3.0 score ≥15 in participants with baseline MELD score ≤12 • Liver decompensation
Time frame: From baseline until 4 weeks after the last dose of study intervention
Percentage of participants who experience any subsequent adjudicated clinical outcome events after the first occurrence of such an event
Among: • All-cause mortality • Liver-related mortality • Liver transplant • MELD-3.0 score ≥15 in participants with baseline MELD score ≤12 • Liver decompensation
Time frame: From baseline until 4 weeks after the last dose of study intervention
Area under the plasma concentration-time curve from time 0 to 24 hours: AUC0-24
Time frame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Maximum (peak) plasma drug concentration: Cmax
Time frame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Time to reach maximum (peak) plasma concentration following drug administration): Tmax
Time frame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Apparent clearance of drug from plasma (CL)
Time frame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Apparent volume of distribution (VZ)
Time frame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
Change from baseline in model for end-stage liver disease (MELD) 3.0 score
The MELD 3.0 score is calculated from parameters (sex, creatinine, bilirubin, INR, sodium and albumin) where a high score indicates a greater risk of needing a liver transplant.
Time frame: From screening until end of treatment (maximum duration of 3.5 years)
Change from baseline in Child Pugh grade
Child Pugh grade is calculated using bilirubin, albumin, INR, ascites and encephalopathy. A high grade is indicative of worse liver disease.
Time frame: From screening until end of treatment (maximum duration of 3.5 years)
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Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Time frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
Access criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Data sharing details ↗ · www.ipsen.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Elifibranor