search
Back to results

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. (ELMWOOD)

Primary Purpose

Primary Sclerosing Cholangitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elafibranor 80 mg
Elafibranor 120 mg
Placebo Matched to Elafibranor 80 mg
Placebo Matched to Elafibranor 120 mg
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria : Participants with a diagnosis of Primary sclerosing cholangitis (PSC) as demonstrated by the presence of the following, and in the absence of apparent causes of secondary sclerosing cholangitis: i) Historical evidence of an elevated Alkaline phosphatase (ALP) > Upper Limit Normal (ULN) since at least 6 months prior to SV1. ii) Cholangiogram (e.g. magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC) with features compatible with large duct PSC. ALP ≥1.5x ULN during screening (with variability ≤30% based on two values). Total bilirubin ≤2.0x ULN at Screening Visit 1(SV1) Participants taking ursodeoxycholic acid (UDCA) at a total daily dose ≤23 mg/kg/day, with a minimum of 6 months of stable treatment prior to screening period and expected to remain on stable dose through the 12-week DBP. Minimum of 3 months off treatment prior to screening period if UDCA was recently discontinued. For participants with Inflammatory bowel disease (IBD): i) Participants with Crohn's disease must be in remission based on the investigator's clinical assessment and should be on stable treatment prior to randomisation and during screening. ii) Participants with ulcerative colitis must be in remission or have low activity disease as per the judgement of the investigator and should be on stable treatment prior to randomisation and during screening. iii) Current treatment for IBD is permitted, if the participant has been well controlled for ≥3 months prior to the screening period and is anticipated to remain on a stable dose of drugs for IBD treatment, including biologics, immunosuppressants, immunomodulators, or systemic corticosteroids. iv) Participants with IBD should have a colonoscopy performed within one year prior to the screening period showing no evidence of dysplasia or cancer. Medications for management of pruritus (e.g. cholestyramine, rifampin, naltrexone or sertraline) must be on a stable dose for ≥3 months prior to the screening period. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. -A female participant is eligible to participate if she is not pregnant or breastfeeding at screening, is willing not to become pregnant during the study and is willing to follow applicable protocol requirements related to this. - Male participants are eligible to participate if they agree to follow applicable protocol requirements related to contraception. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria : History or presence of other concomitant chronic liver disease including: i) ImmunoglobulinG 4 (IgG4) related sclerosing cholangitis, or IgG4 ≥4x ULN at SV1. ii) Small duct PSC. iii) Documented history of secondary sclerosing cholangitis. iv) Presence of hepatitis B surface antigen (HBsAg) at screening. v) Hepatitis C virus (HCV) infection vi) Primary biliary cholangitis (PBC) or positive anti-mitochondrial antibody. vii) Alcohol-related liver disease. viii) Autoimmune hepatitis (AIH): Simplified Diagnostic Criteria of the IAIHG ≥6. ix) Presence of history of PSC-PBC or PSC-AIH overlap syndrome. x) Non-alcoholic steatohepatitis (NASH). SMD form protocol master data--23- INT / Version 1 Known history of alpha-1 antitrypsin deficiency Presence of percutaneous drain or bile duct stent at screening or within three months prior to screening. History of bacterial cholangitis within 60 days prior to the screening period, or participant on antibiotics for prophylaxis of recurrent cholangitis. History or any current suspicion of cholangiocarcinoma or elevated value of carbohydrate antigen 19-9 (CA19-9) >129 U/mL at SV1. Alpha-fetoprotein (AFP) >20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) suggesting presence of liver cancer. Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child-Pugh score. Participants with cirrhosis with Child-Pugh A score are allowed. History of clinically significant hepatic decompensation as described in the study protocol Presence or history of hepatocellular carcinoma. Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease). Medical conditions that may diminish life expectancy to <2 years, including known cancers. Participant has a positive test for human immunodeficiency virus (HIV) type 1 or 2 at SV1, or participant is known to have tested positive for HIV. Evidence of any other unstable or untreated clinically significant immunological, endocrine, neurological, gastrointestinal, haematologic, psychiatric diseases as evaluated by the investigator; other clinically significant conditions that are not well controlled Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix. Participants with previous exposure to elafibranor ALT and/or AST >5x ULN Albumin <3.0 g/dL at SV1. Platelet count <100,000/microliter. International normalised ratio (INR) >1.3 due to altered hepatic function. Creatine phosphokinase (CPK) >2x ULN during screening period. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2

Sites / Locations

  • Om Research LLCRecruiting
  • Cedars-Sinai Medical Center
  • University of California, Davis
  • Sutter Health Van Ness Campus Medical Office Building
  • Peak Gastroenterology AssociatesRecruiting
  • South Denver Gastroenterology,P.C.Recruiting
  • Rocky Mountain Gastroenterology (RMG)Recruiting
  • Yale University School Of Medicine - Yale Center For Clinical InvestigationRecruiting
  • Schiff Center for Liver Diseases - University of MiamiRecruiting
  • Covenant ResearchRecruiting
  • Piedmont Hospital - Piedmont Transplant InstituteRecruiting
  • Tandem Clinical Research GIRecruiting
  • Mercy Medical CenterRecruiting
  • Beth Israel Deaconess Medical Center, Liver Research Center
  • Huron Gastroenterology Associates - Center for Digestive Care
  • University of Nebraska Medical CenterRecruiting
  • Southwest Gastroenterology Associates, PC (SWGA)Recruiting
  • New York University Langone HealthRecruiting
  • Gastro Health ResearchRecruiting
  • Penn State Milton S Hershey Medical Center
  • Thomas Jefferson University
  • Medical University of South CarolinaRecruiting
  • Gastro OneRecruiting
  • University Of Texas Southwestern Medical Center At Dallas
  • American Research Corporation at The Texas Liver InstituteRecruiting
  • Intermountain Medical CenterRecruiting
  • University of Virginia Medical Center
  • Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
  • Virginia Commonwealth UniversityRecruiting
  • Liver Institute NorthwestRecruiting
  • University of Calgary
  • University Of Alberta Hospital-Zeidler Ledcor Centre
  • Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
  • Aspen Woods ClinicRecruiting
  • Centre de Recherche du Centre Hospitalier de l'Universite de MontrealRecruiting
  • G.I Research InstituteRecruiting
  • Charite Campus VirchowRecruiting
  • Klinikum der Johann Wolfgang Goethe-Universitaet FrankfurtRecruiting
  • Universitaetsklinikum Heidelberg - Nationales Centrum fuer Tumorerkrankungen
  • University Hospital Ulm
  • Azienda Ospedaliero Universitaria Modena
  • Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Gruppo Humanitas - Humanitas Research Hospital, Istituto Clinico HumanitasRecruiting
  • Ospedale Casa Sollievo della Sofferenza
  • Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
  • Centro Hospitalar Universitario Lisboa Norte
  • Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
  • Hospital Universitario Vall d'HebronRecruiting
  • Hospital General Universitario Gregorio Maranon (HGUGM)
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Puerta de HierroRecruiting
  • Hospital De MonteceloRecruiting
  • Hospital Universitario Rio Hortega
  • Hospital Universitario Miguel ServetRecruiting
  • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
  • Queen Elizabeth Hospital
  • Frimley Park Hospital - Frimley Health NHS Foundation Trust
  • Glasgow Royal Infirmary - Greater Glasgow Health Board
  • Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
  • Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
  • The Royal Free Hospital - Royal Free London NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Double-Blind Period: Elafibranor 80 mg

Double-Blind Period: Elafibranor 120 mg

Double-Blind Period: Placebo

Open-Label Extension Period: Elafibranor 120 mg

Arm Description

Participant will receive two tablets per day (one tablet of elafibranor 80 mg + 1 tablet of placebo matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.

Participant will receive 2 tablets per day (one tablet of elafibranor 120 mg + 1 tablet of placebo matching the 80 mg sized tablet) over the 12 weeks in Double-blind period.

Participant will receive 2 placebo tablets per day (one matching the 80 mg sized tablet + one matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.

Participant will receive one tablet per day (elafibranor 120 mg) over the 96 weeks in Open-Label extension period.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment Emergent Adverse Event (TEAEs), Treatment Related TEAEs, Serious Adverse (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.
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator.
Percentage 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 decided by the investigator.
Percentage of Participants With 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 decided by the investigator.

Secondary Outcome Measures

Relative Change From Baseline in Alkaline Phosphate Levels (ALP)
Percentage of Participants With ≥40% Decrease from Baseline in ALP Levels
Absolute Change from Baseline in ALP
Percentage of Participants With ALP: <1.3x Upper Limit of Normal (ULN) and <1.5x ULN
Percentage of Participants who Normalised ALP
Change From Baseline in Alanine Transaminase (ALT),Aspartate Transaminase (AST), Gamma-glutamyl transferase (GGT), 5' Nucleotidase and Fractionated ALP Levels at Week 12
Change From Baseline in Total bilirubin, Conjugated bilirubin Levels at Week 12
Change From Baseline in Albumin Levels at Week 12
Change from Baseline in Enhanced Liver Fibrosis (ELF) Test Score
Change From Baseline in Liver Stiffness Measurement (LSM) Values Assessed by FibroScan® at Week 12
Change From Baseline in Other Non-invasive Hepatic Fibrosis Serum Markers as Measured by PAI-1, TGF-β, Marker of type V Collagen Formation (Pro-C5), and Marker of Type III Collagen Formation (Pro-C3)
Change From Baseline in Fibrosis-4 (FIB-4) and AST to Platelet Ratio Index (APRI)
Change From Baseline in Cytokeratin-18 (CK-18) (M65 and M30) Levels
Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUC0-24)
AUC 0-24 will be recorded from the PK blood samples collected.
PK of Elafibranor and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax)
PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
Tmax will be recorded from the PK blood samples collected.
PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)
Cl/F will be recorded from the PK blood samples collected.
PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vz)
Vz will be recorded from the PK blood samples collected.

Full Information

First Posted
November 22, 2022
Last Updated
September 22, 2023
Sponsor
Ipsen
search

1. Study Identification

Unique Protocol Identification Number
NCT05627362
Brief Title
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Acronym
ELMWOOD
Official Title
A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis (PSC).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2023 (Actual)
Primary Completion Date
February 24, 2024 (Anticipated)
Study Completion Date
December 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double-Blind Period: Elafibranor 80 mg
Arm Type
Experimental
Arm Description
Participant will receive two tablets per day (one tablet of elafibranor 80 mg + 1 tablet of placebo matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.
Arm Title
Double-Blind Period: Elafibranor 120 mg
Arm Type
Experimental
Arm Description
Participant will receive 2 tablets per day (one tablet of elafibranor 120 mg + 1 tablet of placebo matching the 80 mg sized tablet) over the 12 weeks in Double-blind period.
Arm Title
Double-Blind Period: Placebo
Arm Type
Placebo Comparator
Arm Description
Participant will receive 2 placebo tablets per day (one matching the 80 mg sized tablet + one matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.
Arm Title
Open-Label Extension Period: Elafibranor 120 mg
Arm Type
Experimental
Arm Description
Participant will receive one tablet per day (elafibranor 120 mg) over the 96 weeks in Open-Label extension period.
Intervention Type
Drug
Intervention Name(s)
Elafibranor 80 mg
Other Intervention Name(s)
GFT505
Intervention Description
Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Elafibranor 120 mg
Other Intervention Name(s)
GFT505
Intervention Description
Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo Matched to Elafibranor 80 mg
Intervention Description
Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo Matched to Elafibranor 120 mg
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Emergent Adverse Event (TEAEs), Treatment Related TEAEs, Serious Adverse (SAEs) and Adverse Events of Special Interest (AESIs)
Description
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.
Time Frame
Double Blind Period: Baseline up to week 12, Open Label Extension (OLE) Period: Baseline up to week 100
Title
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Description
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.
Time Frame
Double Blind Period: Baseline up to week 12, OLE Period: Baseline up to week 100
Title
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
Description
Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator.
Time Frame
Double Blind Period: Baseline up to week 12, OLE Period: Baseline up to week 100
Title
Percentage of Participants With Clinically Significant Changes in Vital Signs
Description
Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.
Time Frame
Double Blind Period: Baseline up to week 12, OLE Period: Baseline up to week 100
Title
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings
Description
Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.
Time Frame
Double Blind Period: Baseline up to week 12, OLE Period: Baseline up to week 100
Secondary Outcome Measure Information:
Title
Relative Change From Baseline in Alkaline Phosphate Levels (ALP)
Time Frame
Double Blind Period: Baseline, Week 12, OLE Period: Baseline, Week 52, Week 96
Title
Percentage of Participants With ≥40% Decrease from Baseline in ALP Levels
Time Frame
Double Blind Period: Baseline, Week 12, OLE Period: Baseline, Week 52, Week 96
Title
Absolute Change from Baseline in ALP
Time Frame
Double Blind Period: Baseline, Week 12, OLE Period: Baseline, Week 52, Week 96
Title
Percentage of Participants With ALP: <1.3x Upper Limit of Normal (ULN) and <1.5x ULN
Time Frame
Double Blind Period: Week 12
Title
Percentage of Participants who Normalised ALP
Time Frame
Double Blind Period: Week 12
Title
Change From Baseline in Alanine Transaminase (ALT),Aspartate Transaminase (AST), Gamma-glutamyl transferase (GGT), 5' Nucleotidase and Fractionated ALP Levels at Week 12
Time Frame
Baseline, Week 12
Title
Change From Baseline in Total bilirubin, Conjugated bilirubin Levels at Week 12
Time Frame
Baseline, Week 12
Title
Change From Baseline in Albumin Levels at Week 12
Time Frame
Baseline, Week 12
Title
Change from Baseline in Enhanced Liver Fibrosis (ELF) Test Score
Time Frame
Double Blind Period: Baseline, Week 12
Title
Change From Baseline in Liver Stiffness Measurement (LSM) Values Assessed by FibroScan® at Week 12
Time Frame
Double Blind Period: Baseline, Week 12
Title
Change From Baseline in Other Non-invasive Hepatic Fibrosis Serum Markers as Measured by PAI-1, TGF-β, Marker of type V Collagen Formation (Pro-C5), and Marker of Type III Collagen Formation (Pro-C3)
Time Frame
Double Blind Period: Baseline, Week 12
Title
Change From Baseline in Fibrosis-4 (FIB-4) and AST to Platelet Ratio Index (APRI)
Time Frame
Double Blind Period: Baseline, Week 12
Title
Change From Baseline in Cytokeratin-18 (CK-18) (M65 and M30) Levels
Time Frame
Double Blind Period: Baseline, Week 12
Title
Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUC0-24)
Description
AUC 0-24 will be recorded from the PK blood samples collected.
Time Frame
Pre-dose, 0.5 hour (h), 1h, between 1.5 hours and 2h, 4h, and 6h after dosing at Week 4
Title
PK of Elafibranor and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax)
Time Frame
Pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at Week 4
Title
PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
Description
Tmax will be recorded from the PK blood samples collected.
Time Frame
Pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at Week 4
Title
PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)
Description
Cl/F will be recorded from the PK blood samples collected.
Time Frame
Double Blind Period: Baseline up to Week 12
Title
PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vz)
Description
Vz will be recorded from the PK blood samples collected.
Time Frame
Double Blind Period: Baseline up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria : Participants with a diagnosis of Primary sclerosing cholangitis (PSC) as demonstrated by the presence of the following, and in the absence of apparent causes of secondary sclerosing cholangitis: i) Historical evidence of an elevated Alkaline phosphatase (ALP) > Upper Limit Normal (ULN) since at least 6 months prior to SV1. ii) Cholangiogram (e.g. magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC) with features compatible with large duct PSC. ALP ≥1.5x ULN during screening (with variability ≤30% based on two values). Total bilirubin ≤2.0x ULN at Screening Visit 1(SV1) Participants taking ursodeoxycholic acid (UDCA) at a total daily dose ≤23 mg/kg/day, with a minimum of 6 months of stable treatment prior to screening period and expected to remain on stable dose through the 12-week DBP. Minimum of 3 months off treatment prior to screening period if UDCA was recently discontinued. For participants with Inflammatory bowel disease (IBD): i) Participants with Crohn's disease must be in remission based on the investigator's clinical assessment and should be on stable treatment prior to randomisation and during screening. ii) Participants with ulcerative colitis must be in remission or have low activity disease as per the judgement of the investigator and should be on stable treatment prior to randomisation and during screening. iii) Current treatment for IBD is permitted, if the participant has been well controlled for ≥3 months prior to the screening period and is anticipated to remain on a stable dose of drugs for IBD treatment, including biologics, immunosuppressants, immunomodulators, or systemic corticosteroids. iv) Participants with IBD should have a colonoscopy performed within one year prior to the screening period showing no evidence of dysplasia or cancer. Medications for management of pruritus (e.g. cholestyramine, rifampin, naltrexone or sertraline) must be on a stable dose for ≥3 months prior to the screening period. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. -A female participant is eligible to participate if she is not pregnant or breastfeeding at screening, is willing not to become pregnant during the study and is willing to follow applicable protocol requirements related to this. - Male participants are eligible to participate if they agree to follow applicable protocol requirements related to contraception. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria : History or presence of other concomitant chronic liver disease including: i) ImmunoglobulinG 4 (IgG4) related sclerosing cholangitis, or IgG4 ≥4x ULN at SV1. ii) Small duct PSC. iii) Documented history of secondary sclerosing cholangitis. iv) Presence of hepatitis B surface antigen (HBsAg) at screening. v) Hepatitis C virus (HCV) infection vi) Primary biliary cholangitis (PBC) or positive anti-mitochondrial antibody. vii) Alcohol-related liver disease. viii) Autoimmune hepatitis (AIH): Simplified Diagnostic Criteria of the IAIHG ≥6. ix) Presence of history of PSC-PBC or PSC-AIH overlap syndrome. x) Non-alcoholic steatohepatitis (NASH). SMD form protocol master data--23- INT / Version 1 Known history of alpha-1 antitrypsin deficiency Presence of percutaneous drain or bile duct stent at screening or within three months prior to screening. History of bacterial cholangitis within 60 days prior to the screening period, or participant on antibiotics for prophylaxis of recurrent cholangitis. History or any current suspicion of cholangiocarcinoma or elevated value of carbohydrate antigen 19-9 (CA19-9) >129 U/mL at SV1. Alpha-fetoprotein (AFP) >20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) suggesting presence of liver cancer. Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child-Pugh score. Participants with cirrhosis with Child-Pugh A score are allowed. History of clinically significant hepatic decompensation as described in the study protocol Presence or history of hepatocellular carcinoma. Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease). Medical conditions that may diminish life expectancy to <2 years, including known cancers. Participant has a positive test for human immunodeficiency virus (HIV) type 1 or 2 at SV1, or participant is known to have tested positive for HIV. Evidence of any other unstable or untreated clinically significant immunological, endocrine, neurological, gastrointestinal, haematologic, psychiatric diseases as evaluated by the investigator; other clinically significant conditions that are not well controlled Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix. Participants with previous exposure to elafibranor ALT and/or AST >5x ULN Albumin <3.0 g/dL at SV1. Platelet count <100,000/microliter. International normalised ratio (INR) >1.3 due to altered hepatic function. Creatine phosphokinase (CPK) >2x ULN during screening period. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ipsen Recruitment Enquiries
Phone
see email
Email
clinical.trials@ipsen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical, Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sutter Health Van Ness Campus Medical Office Building
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
South Denver Gastroenterology,P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Gastroenterology (RMG)
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University School Of Medicine - Yale Center For Clinical Investigation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Schiff Center for Liver Diseases - University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Covenant Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Hospital - Piedmont Transplant Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research GI
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center, Liver Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Huron Gastroenterology Associates - Center for Digestive Care
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Gastroenterology Associates, PC (SWGA)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109-4342
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yale USOMYCFC Investigation
Facility Name
Gastro Health Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19017
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastro One
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Texas Southwestern Medical Center At Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
American Research Corporation at The Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22093
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia C University
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
University Of Alberta Hospital-Zeidler Ledcor Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Aspen Woods Clinic
City
Calgary
ZIP/Postal Code
T3H 0V5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
City
Montréal
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genge Partners
Facility Name
G.I Research Institute
City
Vancouver
ZIP/Postal Code
V6Z 2K5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Charite Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Praxis U Köpenick
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg - Nationales Centrum fuer Tumorerkrankungen
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliero Universitaria Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Gruppo Humanitas - Humanitas Research Hospital, Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IRCCS IC Humanitas
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
City
Guimarães
ZIP/Postal Code
4800-055
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar Universitario Lisboa Norte
City
Lisboa
ZIP/Postal Code
1345-035
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Centro H de Lisboa ocidental (CHLO), Hospital Egas Moniz
Facility Name
Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon (HGUGM)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital De Montecelo
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Frimley Park Hospital - Frimley Health NHS Foundation Trust
City
Frimley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Glasgow Royal Infirmary - Greater Glasgow Health Board
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
The Royal Free Hospital - Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
IPD Sharing 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 EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/

Learn more about this trial

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

We'll reach out to this number within 24 hrs