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Study on Norucholic Acid for Treating Primary Sclerosing Cholangitis in Patients

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the small intestine. The trial is testing a treatment using a medication called norursodeoxycholic acid, also known as norucholic acid or NUC01. This medication is a synthetic form of a bile acid and is taken in the form of hard capsules. The study will compare the effects of NUC01 with a placebo to see if it can help prevent the progression of PSC.

The purpose of the study is to determine if NUC01 is more effective than a placebo in treating PSC. Participants in the study will be randomly assigned to receive either the NUC01 capsules or a placebo. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will last for a period of time, during which participants will take the medication and have regular check-ups to monitor their health and the progression of the disease.

Throughout the study, the main goal is to observe whether there is a partial normalization of a liver enzyme called s-ALP and to ensure there is no worsening of the disease stage. Secondary observations will include liver stiffness, fibrosis stage, liver histology, and quality of life. The study aims to provide valuable information on the effectiveness of NUC01 in managing PSC and potentially improving the lives of those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide a signed informed consent. This document confirms your understanding and agreement to participate in the clinical trial.

    You will be asked to confirm your eligibility, which includes being diagnosed with primary sclerosing cholangitis (PSC) and having a liver biopsy available.

  2. Step 2

    Randomization and treatment assignment

    You will be randomly assigned to receive either the study medication, norursodeoxycholic acid (norUDCA), or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

    The medication will be provided in the form of hard capsules for oral use.

  3. Step 3

    Medication administration

    You will take the assigned medication as directed by the study team. The dosage, frequency, and duration of administration will be specified by the study protocol.

    It is important to follow the instructions carefully and report any side effects or concerns to the study team.

  4. Step 4

    Regular study visits

    You will attend regular study visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and other assessments as required by the study protocol.

    The study team will evaluate your progress and adjust the treatment plan if necessary.

  5. Step 5

    Completion of the double-blind phase

    After completing the double-blind phase of the study, you will have a final visit to assess your condition and the outcomes of the treatment.

    If eligible, you may be invited to participate in an open-label extension (OLE) phase, where you will receive additional information and provide consent for continued participation.

  6. Step 6

    Open-label extension phase

    If you choose to participate in the open-label extension phase, you will continue to receive the study medication, and your health will be monitored as before.

    This phase allows for further evaluation of the treatment's long-term effects and benefits.

Who can join the trial?

6 criteria

  • Signed informed consent: You must agree to participate in the study by signing a document that explains the study and your role in it.
  • Gender: Both males and females can participate.
  • Verified Primary Sclerosing Cholangitis (PSC): You must have a confirmed diagnosis of PSC.
  • Liver biopsy available: A sample of your liver tissue must be available for examination.
  • Women of child-bearing potential: If you are a woman who can become pregnant, you must use a highly effective method of birth control during the study and for four weeks after the last dose of the study drug. This includes methods like hormonal contraception, an intrauterine device (IUD), or having a partner who has had a vasectomy. If you are not able to have children (surgically sterile or post-menopausal for at least 2 years), this does not apply.
  • Inclusion for the open-label extension (OLE) phase: You must sign an additional consent form for this phase and have completed the previous phase of the study.

Who cannot join the trial?

8 criteria

  • Patients who have a different liver disease other than Primary Sclerosing Cholangitis (PSC).
  • Patients who have had a liver transplant.
  • Patients who are currently taking medications that could interfere with the study treatment.
  • Patients who have a history of alcohol or drug abuse.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a serious medical condition that could affect their participation in the study.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Norursodeoxycholic Acid (norUDCA) is a medication being studied for its potential to help people with a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition where the bile ducts, which carry bile from the liver to the small intestine, become inflamed and scarred. This can lead to liver damage over time. Norursodeoxycholic Acid is being tested to see if it can slow down or prevent the progression of this disease, helping to maintain liver function and improve the quality of life for patients.

What is already known about the treatment

Norursodeoxycholic acid – Norursodeoxycholic acid, often referred to as norUDCA, is administered in capsule form and is taken orally. It is currently being studied in a phase III clinical trial to evaluate its effectiveness in treating primary sclerosing cholangitis (PSC), a chronic liver disease. The main goal of this trial is to determine if norUDCA can prevent the progression of PSC better than a placebo. At the molecular level, norUDCA works by modifying bile acid composition and improving bile flow, which may help reduce liver inflammation and damage. It is classified as a bile acid derivative in pharmacology.

Investigated diseases

Primary Sclerosing Cholangitis (PSC) – Primary Sclerosing Cholangitis is a chronic liver disease characterized by inflammation and scarring of the bile ducts inside and outside the liver. Over time, the scarring can cause the bile ducts to become blocked, leading to a buildup of bile in the liver. This can result in liver damage and eventually lead to liver cirrhosis. The disease often progresses slowly, and symptoms may not appear until significant liver damage has occurred. Common symptoms include fatigue, itching, and jaundice, which is a yellowing of the skin and eyes. The exact cause of PSC is unknown, but it is often associated with inflammatory bowel diseases like ulcerative colitis.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510200-42-00Protocol codeNUC-5/PSCEstimated enrolment276 patientsSponsorDr. Falk Pharma GmbH

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).