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New treatment option for Primary Sclerosing Cholangitis
Official title A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
ClinicalTrials.gov ID: NCT07387549
What this study is testing
What is Elafibranor?
Elafibranor is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary sclerosing cholangitis.
Also referred to as IPN60190.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adults participants aged 18 years or older
- Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria
- Compensated liver disease at screening
- Stable background therapy, where applicable prior to study entry
- Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control
You likely can't join if
- \- History or presence of other concomitant chronic liver disease \- History of hepatic decompensation, including: i) History of liver...
- Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child Pugh score.
- History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV.
- History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.
- History or any current suspicion of cholangiocarcinoma or hepatocellular carcinoma
- Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ...
See the full eligibility criteria
- Adults participants aged 18 years or older
- Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria
- Compensated liver disease at screening
- Stable background therapy, where applicable prior to study entry
- Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control
- Ability to provide written informed consent and comply with study procedures.
- \- History or presence of other concomitant chronic liver disease \- History of hepatic decompensation, including: i) History of liver transplantation, current MELD 3.0 score ≥12 due to hepatic impairment. ii) Evidence...
- Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child Pugh score.
- History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV.
- History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.
- History or any current suspicion of cholangiocarcinoma or hepatocellular carcinoma
- 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.
- Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
- Administration of the following medications are prohibited as specified below: i) 3 months prior to baseline: norucholic acid, fibrates, seladelpar and glitazones. ii) 3 months prior to baseline: cyclosporine...
- Participants who are currently participating in, plan to participate in, or have participated in an investigational drug or medical device study containing active substance within 30 days or five half-lives, whichever...
- Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \>450 msec in males or QTcF \>470 msec in females for participants without bundle branch block.
- Significant renal disease,
- For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating.
- 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 to SV.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study.
- Mental instability or incompetence
- Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV.
- Medical conditions that may diminish life expectancy to \<2 years.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Colorado Springs, Colorado, United States
- Johnson City, Tennessee, United States
- San Antonio, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Colorado Springs, Colorado, United States; Johnson City, Tennessee, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.