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Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis

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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 the long-term safety and tolerability of a medication called linerixibat for treating a condition known as cholestatic pruritus in people with Primary Biliary Cholangitis (PBC). Cholestatic pruritus is a type of itching that occurs when there is a problem with bile flow in the liver, and PBC is a chronic disease that slowly destroys the bile ducts in the liver. The medication being tested, linerixibat, is taken in the form of tablets.

The purpose of the study is to evaluate how safe and tolerable linerixibat is when used over a long period. Participants in the study will take linerixibat orally, and the study will monitor them for any side effects or adverse events. The study will involve regular check-ups at various intervals, such as weekly, monthly, and every few months, to ensure the safety of the participants and to gather data on how the medication affects them over time.

Throughout the study, participants will be assessed for changes in their health, including any improvements or worsening of their symptoms. The study will also look at how the medication affects participants' quality of life, including aspects like sleep and fatigue. This trial aims to provide valuable information on the long-term use of linerixibat for individuals with PBC who experience cholestatic pruritus.

The research process

The trial runs in 5 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, participants will be required to provide signed informed consent. This consent confirms understanding and agreement to comply with the study's requirements and restrictions.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes reviewing medical history, menstrual history, and recent sexual activity for female participants to ensure no early undetected pregnancy.

    A highly sensitive urine pregnancy test will be conducted for women of childbearing potential. If the result is ambiguous, a serum pregnancy test will be required.

  3. Step 3

    Treatment initiation

    Participants will begin treatment with linerixibat, administered orally in the form of tablets. The dosage and frequency will be determined by the study protocol and communicated to participants by the study team.

  4. Step 4

    Regular assessments

    Participants will attend regular assessments to monitor the frequency and severity of adverse events. These assessments will occur on Day 1, Week 1, and then monthly at Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, and 48.

    Additional visits may be scheduled as needed to ensure participant safety and study integrity.

  5. Step 5

    Follow-up

    After the final dose of the study medication, a follow-up phone call will be conducted between Day 7 and Day 14 to check on the participant's well-being and any potential late-onset effects.

Who can join the trial?

7 criteria

  • Participants must be 18 to 80 years old at the time of signing the consent form.
  • Participants must have a diagnosis of PBC (Primary Biliary Cholangitis) and a history of itching related to this condition, as shown by their participation in a previous linerixibat study.
  • Participants must have completed the main treatment period in a previous linerixibat study.
  • For female participants only:
    • Must not be pregnant or breastfeeding.
    • If able to have children, must use an acceptable method of birth control during the study and for at least 4 weeks after the last dose of the study medication.
    • Must have a negative pregnancy test before starting the study medication.
    • Participants must be able to give signed informed consent, which means they understand the study and agree to follow its rules.

Who cannot join the trial?

5 criteria

  • Patients with **cholestasis** cannot participate. Cholestasis is a condition where bile flow from the liver is reduced or blocked.
  • Patients with **pruritus** related to **PBC** (Primary Biliary Cholangitis) are excluded. Pruritus means itching, and PBC is a liver disease.
  • Patients outside the age range of 18 to 65 years are not eligible.
  • Both **male** and **female** patients can participate, but certain conditions may exclude them.
  • Patients who are part of a **vulnerable population** are excluded. This means people who might be at higher risk of harm or exploitation.
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Investigated drugs

Linerixibat is a medication being studied for its ability to help people with a condition called cholestatic pruritus, which causes severe itching. This itching is related to a liver disease known as Primary Biliary Cholangitis (PBC). The main goal of using linerixibat in this study is to see if it is safe and can be tolerated by patients over a long period. By taking this medication, patients may experience relief from the persistent itching that comes with their liver condition, potentially improving their quality of life.

What is already known about the treatment

Linerixibat – Linerixibat is administered orally in the form of tablets. It is currently being studied for its long-term safety and tolerability in treating itching associated with a liver condition called primary biliary cholangitis (PBC). The main therapeutic use of Linerixibat is to relieve cholestatic pruritus, which is severe itching due to bile flow problems in the liver. At the molecular level, Linerixibat works by blocking a protein in the intestines that helps transport bile acids, which can reduce the amount of bile acids in the body and alleviate itching. It is classified pharmacologically as an ileal bile acid transporter inhibitor.

Investigated diseases

Cholestasis – Cholestasis is a condition where the flow of bile from the liver is reduced or blocked. This can lead to a buildup of bile acids in the liver and bloodstream. Over time, this accumulation can cause symptoms such as jaundice, dark urine, pale stools, and itching. The condition can be intrahepatic, originating within the liver, or extrahepatic, occurring outside the liver. As cholestasis progresses, it may lead to liver damage due to the toxic effects of bile acids. The severity and progression of symptoms can vary depending on the underlying cause and extent of bile flow obstruction.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503465-33-00Protocol code212358Estimated enrolment292 patientsSponsorGlaxosmithkline Research & Development Limited

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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).