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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04526665
Other study ID # GFT505B-319-1
Secondary ID 2019-004941-34
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 24, 2020
Est. completion date December 1, 2028

Study information

Verified date May 2024
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. This study has two main parts; the first part will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment), and will last between a minimum of one year and a maximum of two years. In the second part, all participants will receive elafibranor, for a period between 4-5 years. The main aim of this study is to determine if elafibranor is better than placebo at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as pruritus and fatigue.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 161
Est. completion date December 1, 2028
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria - Males or females age of 18 to 75 years (inclusive) - Definite or probable PBC diagnosis - ALP = 1.67x upper limit of normal (ULN) - Total bilirubin (TB) = 2x ULN - UDCA for at least 12 months (stable dose = 3 months) prior to screening, or unable to tolerate UDCA treatment (no UDCA for = 3 months) prior to screening (per country standard-of-care dosing) - Must have PBC Worst Itch NRS collected prior to randomization - Females participating in this study must be of non-child bearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the last drug intake Exclusion Criteria: - History or presence of other concomitant liver disease - Clinically significant hepatic decompensation, including patients with complications of cirrhosis/portal hypertension - Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to < 2 years, including known cancers - Patient has a positive test for HIV Type 1 or 2 at screening, or patient is known to have tested positive for HIV - Evidence of any other unstable or untreated clinically significant disease - History of alcohol abuse - For female patients: known pregnancy or lactating - Use of fibrates and glitazones within 2 months prior to screening - Use of OCA, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs - (including a-methyl-dopa, sodium valproic acid isoniazid, or nitrofurantoin) within 3 months prior to screening - Use of antibodies or immunotherapy directed against interleukins (ILs) or other cytokines or chemokines within 12 months prior to screening - For patients with previous exposure to obeticholic acid (OCA), OCA should be discontinued 3 months prior to screening - Patients 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 five half-lives, whichever is longer, prior to screening; for patients with previous exposure to seladelpar, seladelpar should be discontinued 3 months prior to screening - ALT and/or AST values > 5 x ULN - For patients with AT or TB>ULN at SV1, variability of AT or TB > 40% (see section 3.5.1) - Albumin<3.0 g/dl - Severely advanced patients according to Rotterdam criteria (TB > ULN and albumin <LLN) - INR > 1.3 due to altered hepatic function - CPK > 2 x ULN - Screening serum creatinine > 1.5 mg/dl - Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney failure damage or eGFR < 60 mL/min/1,73 m2) calculated by MDRD - Platelet count < 150 x 103/µL - AFP > 20 ng/mL with 4-phase liver CT or MRI imaging suggesting presence of liver cancer - Known hypersensitivity to the investigational product or to any of the formulation excipients of the elafibranor or placebo tablet Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain

Study Design


Intervention

Drug:
Elafibranor 80mg
Elafibranor 80mg daily
Placebo
Placebo daily for double blind period and elafibranor 80 mg daily fo the open label period.

Locations

Country Name City State
Argentina Hospital Alemán Caba Buenos Aires
Argentina Hospital Británico de Buenos Aires Caba Buenos Aires
Argentina Hospital Italiano de Buenos Aires Caba Buenos Aires
Argentina Hospital Espanol De Mendoza Godoy Cruz Mendoza
Argentina Hospital Italiano de La Plata La Plata Provincia De Buenos Aires
Argentina Hospital Provincial del Centenario Rosario Santa Fe
Belgium Hôpital Erasme Brussels
Belgium Antwerp University Hospital Edegem
Belgium Universitair Ziekenhuis Gent Gent
Belgium University Hospital Leuven Leuven
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP São Paulo Sao Paulo
Canada University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC) Calgary Alberta
Canada Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM) Montréal
Canada Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology Vancouver British Columbia
Canada Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre Winnipeg Manitoba
Chile Hospital de La Serena La Serena Coquimbo
Chile Centro de Investigacion Clinica Universidad Catolica CICUC Santiago
Chile Clínica Universidad de los Andes Santiago
Chile Hospital Clínico Universidad de Chile Santiago
Chile Centro de Investigaciones Clinicas (CIC) Viña Del Mar Region De Valparaiso
France CHU Amiens Picardie Amiens
France Hôpital Henri Mondor Créteil
France CHU Grenoble Alpes - Hôpital Albert Michallon Grenoble
France Centre Hospitalier Régional d'Orléans Orléans
France Hôpital Cochin Paris
France Hôpital Pitié-Salpétrière Paris
France Hôpital Saint-Antoine Paris
France Hôpital Haut Lévêque Pessac
France Hôpital Robert Debré - CHU de Reims Reims
France Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Strasbourg
Germany Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik Berlin
Germany Gastro - Sudien Berlin
Germany Universitätsklinikum Frankfurt Frankfurt
Germany Medizinische Hochschule Hannover Hannover
Germany Center for Gastroenterology and Hepatology (GHZ) Kiel Kiel
Germany EUGASTRO GmbH Leipzig
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz
Italy Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi Bologna
Italy Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia Milano
Italy Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale Modena Località Baggiovara
Italy ASST Monza - Ospedale San Gerardo, Gastroenterologia Monza
Italy Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia Padova
Italy Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica Palermo
South Africa Groote Schuur Hospital, University of Cape Town - Clinical Research Centre Cape Town Western Cap
South Africa Mediclinic Constantiaberg, North Suites Cape Town
South Africa Tiervlei Trial Centre Cape Town Western Cape
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta de Hierro -Madrid Madrid
Spain Complexo Hospitalario Universitario de Pontevedra Pontevedra
Spain Hospital Universitario Donostia San Sebastián
Spain Hospital Universitario Marqués de Valdecilla Santander
Spain Hospital Universitario Virgen del Rocio Sevilla
Switzerland Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie Bern
Switzerland Fondazione Epatocentro Ticino Lugano
Turkey Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah. Ankara
Turkey Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali Istanbul Pendik
Turkey Ege Universitesi Tip Fakultesi Hastanesi Izmir Bornova
United Kingdom Belfast Health and Social Care Trust-Royal Victoria Hospital Belfast
United Kingdom Frimley Health NHS Foundation Trust - Frimley Park Hospital Camberley
United Kingdom Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital Cambridge
United Kingdom Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary Hull
United Kingdom King's College Hospital. King's College NHS Foundation Trust London
United Kingdom The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital Newcastle-upon-Tyne Newcastle
United Kingdom Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Nottingham
United Kingdom Plymouth Hospitals NHS Trust, Derriford Hospital Plymouth
United States Texas Clinical Research Institute, LLC Arlington Texas
United States Digestive Healthcare of Georgia Atlanta Georgia
United States University of Colorado Denver and Hospital Aurora Colorado
United States Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States The Institute for Liver Health Chandler Arizona
United States Medical University of South Carolina- College of Medicine Charleston South Carolina
United States University of Virginia Medical Center Charlottesville Virginia
United States Consultants for Clinical Research Cincinnati Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Liver Center of Texas, PLLC Dallas Texas
United States The Liver Institute at Methodist Dallas Medical Center Dallas Texas
United States The University of Texas Southwestern Medical Center-IDS Aston Pharmacy Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States South Denver Gastroenterology, P.C. Englewood Colorado
United States Texas Digestive Disease Consultants dba GI Alliance Fort Worth Texas
United States Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States Liver Associates of Texas, P.A. Houston Texas
United States St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research Houston Texas
United States Carolinas Centre for Liver disease/ Atrium Health Huntersville North Carolina
United States Encore Borland-Groover Clinical Research Jacksonville Florida
United States University of Kansas Medical Center Kansas City Kansas
United States Cedars-Sinai Medical Center Los Angeles California
United States Keck Medical Center of USC Los Angeles California
United States Ruane Clinical Research Group Inc. Los Angeles California
United States Schiff Center for Liver Diseases/University of Miami Miami Florida
United States Intermountain Medical Center - Transplant Services Murray Utah
United States Vanderbilt Digestive Disease Center Nashville Tennessee
United States Yale School of Medicine, Digestive Diseases New Haven Connecticut
United States UPMC Center for Liver Diseases New Hyde Park New York
United States Columbia University Medical Center - Center for Liver Disease and Transplantation New York New York
United States NYU Langone Health / NYU Grossman School of Medicine New York New York
United States The New York-Presbyterian Hospital, David H. Koch Center New York New York
United States Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads Newport News Virginia
United States Henry Ford Health System Novi Michigan
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond Richmond Virginia
United States Virginia Commonwealth University Clinical Research Services Unit (CRSU) Richmond Virginia
United States University of California, Davis Medical Center Sacramento California
United States Saint Louis University Saint Louis Missouri
United States University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition Salt Lake City Utah
United States American Research Corporation San Antonio Texas
United States California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco California
United States Liver Institute Northwest Seattle Washington
United States Gastro health & Nutrition-Victoria Victoria Texas

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Chile,  France,  Germany,  Italy,  South Africa,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with response to treatment measured by the combination levels of Alkaline Phosphate Levels (ALP) and Total Bilirubin (TB) At Week 52
Secondary Percentage of participants who normalised ALP levels At Week 52
Secondary Change in pruritus from baseline in participants with baseline PBC Worst Itch NRS Score = 4 Through 52 weeks of treatment
Secondary Change in pruritus from baseline in participants with baseline PBC Worst Itch NRS Score = 4 Through 24 weeks of treatment
Secondary Change from baseline in ALP levels At Week 4, 13, 26, 39 and Week 52 and up to a maximum of 6 years
Secondary Percentage of participants with =10%, =20%, and =40% decrease from Baseline in ALP Levels From baseline to Week 52 and up to a maximum of 6 years
Secondary Percentage of Participants with response to treatment Based on different biochemical response criteria At Week 52 and up to a maximum of 6 years
Secondary Change from baseline in PBC risk scores based on United Kingdom (UK)-PBC score. the UK-PBC risk score estimates the risk that a patient with PBC will require liver transplantation within 5, 10 or 15 years. A high number is indicative of a worse prognosis. At Week 52 and up to a maximum of 6 years
Secondary Change from baseline in Global PBC Study Group (GLOBE) score The GLOBE score is a prognostic tool used to identify patients with PBC who are at higher/lower risk of liver transplant or death. A high number is indicative of a worse prognosis. At Week 52 and up to a maximum of 6 years
Secondary Percentage of participants who normalised bilirubin levels At Week 52 and up to a maximum of 6 years
Secondary Percentage of participants who normalised albumin levels At Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of aspartate aminotransferase (AST) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of alanine aminotransferase (ALT ) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of gamma-glutamyl transferase (GGT) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of 5'-nucleotidase (5' NT) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of total and conjugated bilirubin From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of albumin From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in international normalised ratio (INR) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in fractionated alkaline phosphatase (ALP) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of high sensitivity C-reactive protein (hsCRP) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of fibrinogen From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of haptoglobin From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of tumor necrosis factor-alpha (TNF-a) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of immunoglobulin G (IgG) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of immunoglobulin M (IgM) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in enhanced liver fibrosis (ELF) score From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of plasminogen activator inhibitor-1 (PAI-1) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of transforming growth factor beta (TGF-ß) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of cytokeratin-18 (CK-18) (M65 and M30) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of Pro-C3 From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in liver stiffness as measured by Transient Elastography (TE) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of total cholesterol (TC) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of low density lipoprotein cholesterol (LDL-C) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of high density lipoprotein cholesterol (HDL-C) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in calculated very low density lipoprotein cholesterol (VLDL-C) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of triglycerides (TG) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in Fasting Plasma Glucose (FPG) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of individual bile acids From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of 7-a-hydroxy-4-cholesten-3-one (C4) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of fibroblast growth factor 19 (FGF19) From baseline to Week 52 and up to a maximum of 6 years
Secondary Percentage of participants with no worsening of pruritus Measured by the PBC Worst Itch Numeric Rating Scale (NRS) From baseline to week 52 and up to a maximum of 6 years
Secondary Percentage of responders in PBC Worst Itch NRS Defined as at least 30% reduction from baseline of NRS at week 52 in patients with a baseline NRS = 4 Baseline through 52 weeks and up to a maximum of 6 years
Secondary Change from baseline in 5D-Itch 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
From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a Change from baseline in assessing seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in Epworth Sleepiness Scale (ESS) Change from baseline in ESS that assesses eight questions asking to rate how likely it is to fall asleep in everyday situations (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 patient's level of daytime sleepiness (total score range 0-24 points). From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in PBC-40 Assesses symptoms across six domains: fatigue, emotional and 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.
From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in health utility Measured by Euro quality of life (EQ-5D-5L), a 6-item, standardized questionnaire that assesses mobility, self-care, usual activities, pain / discomfort, anxiety / depression, and overall health state From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of type I collagen N-telopeptides (CTXI) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in levels of procollagen 1 N-terminal propeptide (P1NP) From baseline to Week 52 and up to a maximum of 6 years
Secondary Change from baseline in bone mineral density (hip and lumbar) as assessed by DEXA scanning From baseline to Week 52 and up to a maximum of 6 years
Secondary Percentage of patients with onset of clinical outcomes From baseline to Week 52 and up to a maximum of 6 years
Secondary Number of participants experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs). An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not 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. From baseline to Week 52 and up to a maximum of 6 years
Secondary Number of participants with clinically significant changes in physical examination Percentage of participants with clinically significant changes in physical examination will be reported. The clinical significance will be graded by the investigator. From baseline to Week 52 and up to a maximum of 6 years
Secondary Number of participants with 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. From baseline to Week 52 and up to a maximum of 6 years
Secondary Number of participants with clinically significant changes in electrocardiogram (ECG) Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be graded by the investigator. From baseline to Week 52 and up to a maximum of 6 years
Secondary Number of participants with clinically significant changes in laboratory parameters (blood chemistry and hematology) 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. From baseline to Week 52 and up to a maximum of 6 years
Secondary Number of Participants With Clinically Significant Changes in liver markers From baseline to Week 52 and up to a maximum of 6 years
Secondary Number of Participants With Clinically Significant Changes in Renal biomarkers (including urinalysis) From baseline to Week 52 and up to a maximum of 6 years
Secondary Number of Participants With Clinically Significant Changes in other biochemical safety markers (e.g. urinary myoglobin) From baseline to Week 52 and up to a maximum of 6 years
Secondary Area Under Curve steady state (AUCss) of study drug After 4 weeks of treatment during the double-blind period
Secondary Pharmacokinetic (PK) Parameter: Clearance (CL) of study drug Clearance (CL) is defined as the systemic clearance of the drug following oral administration. After 4 weeks of treatment during the double-blind period
Secondary Pharmacokinetic (PK) Parameter: Vz of study drug Vz is defined as the volume of distribution of the drug after oral administration. After 4 weeks of treatment during the double-blind period
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