Can a pill stop the relentless itch of a liver disease? a major trial aims to find out.
NCT ID NCT04950127
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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238 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Dec 2024
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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GSK Investigational Site
Erlangen, 91054, Germany
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GSK Investigational Site
Münster, 48149, Germany
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GSK Investigational Site
Cambridge, CB2 0QQ, United Kingdom
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GSK Investigational Site
Durham, DH1 5TW, United Kingdom
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GSK Investigational Site
Newcastle upon Tyne, NE4 6BE, United Kingdom
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