Primary Biliary CholangitisPhase 3ELSPIRENCT06383403
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
A Phase 3 study testing Elafibranor in people with Primary Biliary Cholangitis, run by Ipsen at 60 sites in 10 countries.
Trial summary
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- Elafibranor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 60 sitesin 10 countries
- Study dates
- 9 Jul 2024to 16 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants age ≥18 years of age.
- Participants with a historical diagnosis of PBC as demonstrated by the presence of ≥2 of the following three historical diagnostic criteria:
- i. History of elevated ALP levels for ≥6 months prior to the first screening visit (SV1).
- ii. Positive Antimitochondrial antibody (AMA) titres (≥1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay) or positive PBC-specific antinuclear antibodies.
- iii. Liver biopsy consistent with PBC.
- ALP >1 × ULN and <1.67 × ULN.
Show all 11Show fewer
- Participants taking UDCA should have been on this medication for at least 6 months and at a stable dose for ≥3 months. Participants who are intolerant to UDCA should have taken the last dose of UDCA ≥3 months prior.
- Participants taking medications for management of pruritus must be on a stable dose for ≥3 months.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- (a) Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participant must agree to use contraception during the whole period of the study and for 30 days after the last dose of study intervention.
- Capable of giving signed informed consent
Who cannot join
- History or presence of other concomitant liver diseases.
- Participants with known cirrhosis who have a Child-Pugh B or C score. Participants with cirrhosis with Child-Pugh A score are allowed.
- History of liver transplantation.
- History or presence of clinically significant hepatic decompensation.
- Known history of human immunodeficiency virus (HIV) infection.
- Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
Show all 29Show fewer
- Evidence of any other unstable or untreated clinically significant conditions that are not well controlled.
- Medical condition with a life expectancy <2 years.
- Known malignancy or history of malignancy within the last 2 years, except for successfully treated localised basal cell carcinoma or squamous cell carcinoma of the skin; or in-situ carcinoma of the uterine cervix.
- History of hepatocellular carcinoma.
- Alpha-foetoprotein (AFP) >20 ng/mL with 4-phase liver computed tomography (CT) or magnetic resonance imaging (MRI) scans suggesting presence of liver cancer.
- Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below:
- i. Systemic (oral or parenteral) use within 3 months prior to SV1 of: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, or long-term systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, valproic acid, isoniazid or nitrofurantoin)
- Participants with previous exposure to elafibranor.
- Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer.
- Total bilirubin (TB) >2 × ULN. Participants with Gilbert's syndrome are eligible with a TB above 2 × ULN if direct bilirubin is <30% of TB.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 × ULN.
- Creatine phosphokinase (CPK) >2 × ULN.
- Platelet count <75,000/µL.
- International normalised ratio >1.3 in the absence of anticoagulant therapy.
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2.
- Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
- Other exclusions
- For female participants: known pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
- Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women.
- History of alcohol abuse, or other substance abuse within 1 year prior.
- Known hypersensitivity to the investigational product or to any of the excipients of elafibranor.
- Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
- Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.
Trial locations and contacts
60 sites in 10 countries.
60 sites in 10 countries
United States20 sites
Southwest Gastroenterology Associates, PC (SWGA)
Albuquerque, New Mexico, 87109
University of Michigan Health System
Ann Arbor, Michigan, 48109
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28277
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80135
Gastroenterology Center of the Midsouth
Cordova, Tennessee, 38018
Southern California Research Center
Coronado, California, 92118
Methodist Transplant Physicians
Dallas, Texas, 75203
South Denver Gastroenterology,P.C.
Englewood, New Jersey, 80113
Coastal Research Institute
Fayetteville, North Carolina, 28304
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120
Topgraphy Health, Inc.
Los Angeles, California, 90005
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, 11030
University of California, Davis
Sacramento, California, 95616
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, 78215
American Research Corporation
San Antonio, Texas, 78215
Velocity Liver Institute NW
Seattle, Washington, 98105
Stanford University Medical Center
Stanford, California, 94305
International Center for Research
Tampa, Florida, 33614
Delta Research Partners, LLC
West Monroe, Louisiana, 71291
Huron Gastroenterology Associates - Center for Digestive Care
Ypsilanti, Michigan, 48197
South Korea10 sites
Korea University Ansan Hospital
Ansan-si
Keimyung University Dongsan Hospital
Daegu
Kyungpook National University Hospital (KNUH)
Daegu
Pusan National University Hospital (PNUH)
Pusan
CHA Bundang Medical Center, CHA University
Seongnam-si
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
United Kingdom7 sites
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
Aberdeen
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford
Frimley Park Hospital - Frimley Health NHS Foundation Trust
Frimley
Queen Elizabeth University Hospital - Greater Glasgow Health Board
Glasgow
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
Hull
Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
London
King's College Hospital
London
Spain6 sites
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
Sabadell
Hospital Universitario Miguel Servet
Zaragoza
Czechia4 sites
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové
Artroscan
Ostrava
Research Site s.r.o.
Pilsen
Institute for Clinical and Experimental Medicine - IKEM
Prague
Germany4 sites
Universitatsklinikum Heidelberg
Heidelberg
Gastroenterologsiche Studiengesellschaft Herne
Hemer
EUGASTRO GmbH
Leipzig
Universitaetsklinikum Muenster
Münster
Italy4 sites
Ospedale Policlinico San Martino - IRCCS
Genova
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo
Azienda Ospedaliero Universitaria Pisana
Pisa
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano
Poland2 sites
Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds
Krakow
FutureMeds Warszawa Centrum
Warsaw
Romania2 sites
Cluj County Clinical Emergency Hospital
Cluj-Napoca
Gastromedica Srl
Iași
About this study
Official title: A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 scarring (cirrhosis). PBC may also be associated with multiple symptoms.
Read more
Many patients with PBC may require a 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).
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.
There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.
Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).
They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Elafibranor, Placebo
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElafibranorDrug
Also called IPN60190
Round and orange film coated tablet of 80 mg.
PlaceboOther
Round and orange film coated tablet of placebo
| Study group | Role | What they receive |
|---|---|---|
| Elafibranor 80 mg | Experimental | Participants will take 1 tablet of elafibranor 80 mg per day orally before breakfast with a glass of water at approximately the same time each morning. Receives: Drug: Elafibranor |
| Placebo | Placebo comparator | Participants will take 1 placebo tablet per day orally before breakfast with a glass of water at approximately the same time each morning. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with normalisation of Alkaline Phosphate (ALP) Levels
Measured: At Week 52
Secondary outcomes (22)
Percentage of participants with normalisation of ALP Levels
Measured: From baseline to Week 4, Week 12, Week 24 and Week 36
Change from baseline in ALP levels
Measured: From baseline to Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with normalisation of ALP Levels and ≥15% decrease from Baseline
Measured: From baseline to Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with ≥40% decrease from Baseline in ALP Levels
Measured: From baseline to Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with ALP <0.5 × Upper Limit of Normal (ULN)
Measured: At Week 4, Week 12, Week 24, Week 36 and Week 52
Changes from baseline in Total Bilirubin (TB) Levels
Measured: From baseline to Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with TB <0.7 × ULN
Measured: At Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with normalisation of ALP and TB <0.7 × ULN
Measured: At Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with normalisation of TB and ALP Levels
Measured: At Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with complete biochemical response
Defined as normal levels of TB, ALP, aminotransferases, albumin, and International normalised ratio (INR)
Measured: At Week 4, Week 12, Week 24, Week 36 and Week 52
Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score
PBC Worst Itch Numeric Rating Scale (NRS) is a 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)
Measured: From baseline through Week 52
Percentage of participants with moderate to severe pruritus at baseline (i.e. score ≥4) with a clinically meaningful response in PBC Worst Itch NRS
Defined as ≥1.8-point reduction from baseline
Measured: From baseline through Week 52
Change from baseline in 5-D itch score
Change from baseline in symptoms in terms of 5 domains: degree, duration, direction, disability and distribution. Patients rate their symptoms over the preceding 2-week period on a 1 to 5 scale, with 5 being the most affected.
Measured: From baseline to Week 4, Week 24, and Week 52
Change from baseline in Patient Global Impression of Severity (PGI-S) scores
Patient Global Impression of Severity (PGI-S) is a 1-item, 5-point scale designed to assess the participant's impression of itch severity over the past 7 days, at different time points during the study.
Measured: From baseline to Week 4, Week 24, and Week 52
Patient Global Impression of Change (PGI-C) scores
Patient Global Impression of Change (PGI-C) is a 1-item, 5-point scale designed to assess the participant's impression of change in itch severity since the baseline visit
Measured: At Week 4, Week 24, and Week 52
Change from baseline in PBC-40 Quality of Life (QoL) scores
PBC-40 Quality of Life (QoL) assesses symptoms across six domains: fatigue, emotional, social, cognitive function, general symptoms and itch. Patients 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'. Five items (3/3 in the itch domain and 2/10 in the social 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 1-5 per item (0-5 on items with a 'does not apply' option) with 5 being the most affected. The PBC-40 has a 4-week recall period.
Measured: From baseline to Week 4, Week 24, and Week 52
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a scores
PROMIS Fatigue Short Form 7a scores 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.
Measured: From baseline to Week 4, Week 24, and Week 52
Percentage of participants experiencing Treatment- Emergent Adverse Events (TEAEs), treatment- related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs).
An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs.
Measured: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Percentage of participants developing clinically significant changes in physical examination
The clinical significance will be graded by the investigator.
Measured: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Percentage of participants developing clinically significant changes in vital signs
The clinical significance will be graded by the investigator.
Measured: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) Readings
The clinical significance will be graded by the investigator.
Measured: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Percentage of participants developing clinically significant changes in laboratory parameters
The following laboratory parameters will be reported: blood chemistry, hematology and coagulation, liver tests and renal tests (including urinalysis). The clinical significance will be graded by the investigator.
Measured: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start9 Jul 2024
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383403
- Sponsor's protocol ID
- CLIN-60190-463
- Other IDs
- 2024-510695-20-00
- Acronym
- ELSPIRE
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
- ClinicalTrials.gov ID
- NCT06383403
- Acronym / sponsor ID
- ELSPIRE / CLIN-60190-463
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.
Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 scarring (cirrhosis). PBC may also be associated with multiple symptoms.
Many patients with PBC may require a 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).
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.
There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.
Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).
Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).
They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elafibranor 80 mg | Experimental | Drug: ElafibranorParticipants will take 1 tablet of elafibranor 80 mg per day orally before breakfast with a glass of water at approximately the same time each morning. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will take 1 placebo tablet per day orally before breakfast with a glass of water at approximately the same time each morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female participants age ≥18 years of age.
- Participants with a historical diagnosis of PBC as demonstrated by the presence of ≥2 of the following three historical diagnostic criteria:
- ALP >1 × ULN and <1.67 × ULN.
- Participants taking UDCA should have been on this medication for at least 6 months and at a stable dose for ≥3 months. Participants who are intolerant to UDCA should have taken the last dose of UDCA ≥3 months prior.
- Participants taking medications for management of pruritus must be on a stable dose for ≥3 months.
Key exclusion criteria (29 listed)
- History or presence of other concomitant liver diseases.
- Participants with known cirrhosis who have a Child-Pugh B or C score. Participants with cirrhosis with Child-Pugh A score are allowed.
- History of liver transplantation.
- History or presence of clinically significant hepatic decompensation.
- Known history of human immunodeficiency virus (HIV) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElafibranorAlso: IPN60190Round and orange film coated tablet of 80 mg. | Drug | Elafibranor 80 mg |
| PlaceboRound and orange film coated tablet of placebo | Other | Placebo |
Primary outcome
Percentage of participants with normalisation of Alkaline Phosphate (ALP) Levels
Time frame: At Week 52
22 secondary outcomes
Percentage of participants with normalisation of ALP Levels
Time frame: From baseline to Week 4, Week 12, Week 24 and Week 36
Change from baseline in ALP levels
Time frame: From baseline to Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with normalisation of ALP Levels and ≥15% decrease from Baseline
Time frame: From baseline to Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with ≥40% decrease from Baseline in ALP Levels
Time frame: From baseline to Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with ALP <0.5 × Upper Limit of Normal (ULN)
Time frame: At Week 4, Week 12, Week 24, Week 36 and Week 52
Changes from baseline in Total Bilirubin (TB) Levels
Time frame: From baseline to Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with TB <0.7 × ULN
Time frame: At Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with normalisation of ALP and TB <0.7 × ULN
Time frame: At Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with normalisation of TB and ALP Levels
Time frame: At Week 4, Week 12, Week 24, Week 36 and Week 52
Percentage of participants with complete biochemical response
Time frame: At Week 4, Week 12, Week 24, Week 36 and Week 52
Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score
Time frame: From baseline through Week 52
Percentage of participants with moderate to severe pruritus at baseline (i.e. score ≥4) with a clinically meaningful response in PBC Worst Itch NRS
Time frame: From baseline through Week 52
Change from baseline in 5-D itch score
Time frame: From baseline to Week 4, Week 24, and Week 52
Change from baseline in Patient Global Impression of Severity (PGI-S) scores
Time frame: From baseline to Week 4, Week 24, and Week 52
Patient Global Impression of Change (PGI-C) scores
Time frame: At Week 4, Week 24, and Week 52
Change from baseline in PBC-40 Quality of Life (QoL) scores
Time frame: From baseline to Week 4, Week 24, and Week 52
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a scores
Time frame: From baseline to Week 4, Week 24, and Week 52
Percentage of participants experiencing Treatment- Emergent Adverse Events (TEAEs), treatment- related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs).
Time frame: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Percentage of participants developing clinically significant changes in physical examination
Time frame: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Percentage of participants developing clinically significant changes in vital signs
Time frame: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) Readings
Time frame: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Percentage of participants developing clinically significant changes in laboratory parameters
Time frame: From baseline until 4 weeks after the end of treatment (maximum duration of 52 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
60 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elafibranor in people with Primary Biliary Cholangitis, run by Ipsen at 60 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, South Korea, United Kingdom, Spain, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with normalisation of Alkaline Phosphate (ALP) Levels (time frame: At Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.