BridgeMD
A Study to Assess how Well and Safely Elafibranor Works in Adult Participants with Primary Sclerosing Cholangitis
EU CTIS ID: 2026-525242-29-00
What this study is testing
To evaluate the efficacy of daily oral administration of elafibranor 120 mg compared to placebo based on time to first occurrence of clinical outcome events in adult participants with PSC
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Adults participants aged 18 years or older.
- 2. Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria
- 3. Compensated liver disease at screening
- 4. Stable background therapy, where applicable prior to study entry
- 5. Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control
- 6. Ability to provide written informed consent and comply with study procedures.
You likely can't join if
- 1. History or presence of other concomitant chronic liver disease
- 10. Administration of the following medications are prohibited as specified below: i) 3 months prior to baseline: norucholic acid, ileal bile acid transportinhibitors, fibrates, seladelpar and glitazones. ii) 3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose and as part of management of adrenal insufficiency as specified in Appendix 10.5.2); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin).
- 11. 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 is longer, prior to the SV.
- 12. Participants with previous exposure to elafibranor.
- 13. 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. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF >480 msec would be exclusionary.
- 14. Liver related laboratory tests.
See the full eligibility criteria
Who can join
- 1. Adults participants aged 18 years or older.
- 2. Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria
- 3. Compensated liver disease at screening
- 4. Stable background therapy, where applicable prior to study entry
- 5. Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control
- 6. Ability to provide written informed consent and comply with study procedures.
What rules you out
- 1. History or presence of other concomitant chronic liver disease
- 10. Administration of the following medications are prohibited as specified below: i) 3 months prior to baseline: norucholic acid, ileal bile acid transportinhibitors, fibrates, seladelpar and glitazones. ii) 3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose and as part of management of adrenal insufficiency as specified in Appendix 10.5.2); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin).
- 11. 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 is longer, prior to the SV.
- 12. Participants with previous exposure to elafibranor.
- 13. 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. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF >480 msec would be exclusionary.
- 14. Liver related laboratory tests.
- 15. Significant renal disease
- 16. Creatine phosphokinase (CPK) >2× ULN during SV.
- 17. For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating.
- 18. Regular alcohol intake in excess of the recommended limit of two standard drinks per day for men or one standard drink per day for women
- 19. History of alcohol abuse, or other substance abuse within one year prior to SV.
- 2. Presence of hepatitis B surface antigen at SV, or hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA)
- 20. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- 21. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
- 22. Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV.
- 23. Other medical conditions that may diminish life expectancy to <2 years.
- 3. History of hepatic decompensation, including: i) History of liver transplantation, ii) Current MELD 3.0 score ≥12 due to hepatic impairment, iii) Evidence of complications of cirrhosis.
- 4. Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child-Pugh score.
- 5. History of biliary intervention within 60 days prior to the screening period, and/or presence of percutaneous drain or bile duct stent at SV.
- 6. History of bacterial cholangitis, and/or participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.
- 7. History or any current suspicion of cholangiocarcinoma or Hepatocellular carcinoma
- 8. Known malignancy or history of malignancy within the last five years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
- 9. Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget’s disease).
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Australia
- Japan
- Argentina
- Switzerland
- China
- Korea, Republic of
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Australia; Japan; Argentina; Switzerland; China and 4 more location(s). 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 EU CTIS; the study team decides eligibility.