Can a pill stop the relentless itch of a liver disease? a major trial aims to find out.

NCT ID NCT04950127

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 3 trial is testing an experimental drug called linerixibat against a placebo in about 238 adults with primary biliary cholangitis (PBC) who suffer from moderate to severe itching. The goal is to see if linerixibat can reduce itch severity and improve quality of life over 24 weeks. Participants take the drug or placebo twice daily and report their itch scores using a 0-to-10 scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called linerixibat
What this could lead to
If it works, this could offer a new treatment option for the debilitating itch that affects many people with primary biliary cholangitis.
What could go wrong
This is an early-stage trial, so the drug may not prove effective or could have side effects. Itching is subjective, making it hard to measure improvement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

238 people

The number who actually took part.

Started

Aug 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent. * Participants who have documented PBC. * Participants who have moderate to severe itch. Exclusion Criteria: * Total bilirubin \>2.0 times Upper Limit of Normal (ULN) using the average of two Baseline measures. * Screening Alanine Aminotransferase (ALT) \> 6 times ULN in a single Baseline measure or ALT \> 5 times ULN using the average of two Baseline measures. * Screening estimated glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2). * History or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites). * Presence of HBsAg positive hepatitis B or hepatitis C (HCV) (anti-HCV and Ribonucleic acid \[RNA\] detected) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer. * Current clinically significant diarrhea or active inflammatory ileal disease according to Investigator´s clinical judgment. * Current symptomatic cholelithiasis or cholecystitis. * Current diagnosis of primary skin disorders with itch as a characteristic feature (e.g., atopic dermatitis, psoriasis). * Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia. * Initiation, discontinuation or change in dose of ursodeoxycholic acid (UDCA), bezafibrate or fenofibrate in the 8 weeks prior to Screening. * Use of obeticholic acid: within 8 weeks prior to Screening. (Participants may not initiate or restart during the study). * Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selective serotonin reuptake inhibitor (SSRIs), antihistamines used for the treatment of itching. * Administration of any other human ileal bile acid transporter (IBAT) inhibitor in the 12 weeks prior to screening. * Any planned procedures intended to treat cholestatic pruritus such as nasobiliary drainage or ultraviolet light therapy from Screening and throughout the study. * History of sensitivity or intolerance to the study treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • GSK Investigational Site

    Erlangen, 91054, Germany

  • GSK Investigational Site

    Münster, 48149, Germany

  • GSK Investigational Site

    Cambridge, CB2 0QQ, United Kingdom

  • GSK Investigational Site

    Durham, DH1 5TW, United Kingdom

  • GSK Investigational Site

    Newcastle upon Tyne, NE4 6BE, United Kingdom

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