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New drug shows promise for relieving severe itch in liver disease

NCT ID NCT04167358

Symptom relief Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the long-term safety of linerixibat, a drug for severe itching caused by primary biliary cholangitis (PBC). All 242 participants receive the drug openly. The goal is to see if it remains safe over time and improves quality of life.

What this could mean

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

Active substance
linerixibat
What this could lead to
If successful, this could confirm linerixibat as a safe long-term option to ease severe itching in people with primary biliary cholangitis.
What could go wrong
This is an open-label study with no placebo group, so results may be biased. It focuses on safety, not whether the drug works better than no treatment.

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

242 people

The number who actually took part.

Started

Jul 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

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 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent trial BAT117213, GLIMMER or GLISTEN. * Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN). * Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN). * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is a woman of non-childbearing potential (WONCBP) or b) is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method. * Capable of giving signed informed consent. Exclusion Criteria: * Screening total bilirubin \>2x upper limit of normal (ULN). * Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>6x ULN. * Screening estimated glomerular filtration rate (eGFR) \<30 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. * Presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites). * Presence of actively replicating viral hepatitis B or C (Viral Hepatitis B \[HBV\], viral Hepatitis C \[HCV\]) infection), primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer. * Current clinically significant diarrhea in the Investigator's medical opinion. * Current symptomatic cholelithiasis or cholecystitis. * Current diagnosis or previous diagnosis of colorectal cancer. * Any current malignancies (including hematologic and solid malignancies). * History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years. * Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or early study withdrawal. * Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening until after the end of the study or early study withdrawal. * QT interval corrected (QTc) \>480 millisecond (msec) at screening (12-lead ECG) * Participants with moderate (or greater) alcohol consumption defined as more than one standard drink per day for women and two drinks per day for men.

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Conditions

The condition(s) this trial relates to.

cholestasis primary biliary cholangitis

As listed by the trial registrant

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

Cholestasis

Contacts and locations

Locations

  • GSK Investigational Site

    Davis, California, 95817, United States

  • GSK Investigational Site

    West Hollywood, California, 90048, United States

  • GSK Investigational Site

    Miami, Florida, 33136, United States

  • GSK Investigational Site

    Detroit, Michigan, 48377, United States

  • GSK Investigational Site

    New York, New York, 10016, United States

  • GSK Investigational Site

    Durham, North Carolina, 27710, United States

  • GSK Investigational Site

    Morrisville, North Carolina, 27560, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Dallas, Texas, 75390, United States

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    Seattle, Washington, 98105, United States

  • GSK Investigational Site

    Buenos Aires, C1061AAS, Argentina

  • GSK Investigational Site

    Capital Federal, C1181ACI, Argentina

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, 1118, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABI, Argentina

  • GSK Investigational Site

    Rosario, S2002KDT, Argentina

  • GSK Investigational Site

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035003, Brazil

  • GSK Investigational Site

    Botucatu, 18618686, Brazil

  • GSK Investigational Site

    Brasília, 70335-900, Brazil

  • GSK Investigational Site

    Salvador, 40110-160, Brazil

  • GSK Investigational Site

    Sofia, 1618, Bulgaria

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2X8, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4, Canada

  • GSK Investigational Site

    Beijing, 100032, China

  • GSK Investigational Site

    Beijing, 100069, China

  • GSK Investigational Site

    Changchun, 130021, China

  • GSK Investigational Site

    Chongqing, 400042, China

  • GSK Investigational Site

    Guangzhou, 510630, China

  • GSK Investigational Site

    Nanchang, 330006, China

  • GSK Investigational Site

    Nanjing, 210003, China

  • GSK Investigational Site

    Shanghai, 200127, China

  • GSK Investigational Site

    Tianjin, 300000, China

  • GSK Investigational Site

    Pilsen, 30100, Czechia

  • GSK Investigational Site

    Prague, 140 21, Czechia

  • GSK Investigational Site

    Lille, 59037, France

  • GSK Investigational Site

    Erlangen, 91054, Germany

  • GSK Investigational Site

    Münster, 48149, Germany

  • GSK Investigational Site

    Haifa, 34362, Israel

  • GSK Investigational Site

    Holon, 58100, Israel

  • GSK Investigational Site

    Jerusalem, 91120, Israel

  • GSK Investigational Site

    Rehovot, 76100, Israel

  • GSK Investigational Site

    Milan, 20142, Italy

  • GSK Investigational Site

    Modena, 41126, Italy

  • GSK Investigational Site

    Monza, 20900, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Negrar Verona, 37024, Italy

  • GSK Investigational Site

    Padova, 35128, Italy

  • GSK Investigational Site

    Palermo, 90127, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Chiba, 270-1694, Japan

  • GSK Investigational Site

    Ehime, 791-0295, Japan

  • GSK Investigational Site

    Fukui, 918-8503, Japan

  • GSK Investigational Site

    Gunma, 371-8511, Japan

  • GSK Investigational Site

    Hiroshima, 730-8619, Japan

  • GSK Investigational Site

    Hiroshima, 734-8551, Japan

  • GSK Investigational Site

    Hokkaido, 006-8555, Japan

  • GSK Investigational Site

    Kagawa, 760-8557, Japan

  • GSK Investigational Site

    Kanagawa, 259-1143, Japan

  • GSK Investigational Site

    Nagano, 390-8621, Japan

  • GSK Investigational Site

    Nagasaki, 856-8562, Japan

  • GSK Investigational Site

    Nara, 634-8522, Japan

  • GSK Investigational Site

    Osaka, 545-8586, Japan

  • GSK Investigational Site

    Osaka, 591-8025, Japan

  • GSK Investigational Site

    Shizuoka, 431-3192, Japan

  • GSK Investigational Site

    Tokyo, 113-8603, Japan

  • GSK Investigational Site

    Tokyo, 162-8655, Japan

  • GSK Investigational Site

    Tokyo, 173-8606, Japan

  • GSK Investigational Site

    Tokyo, 181-8611, Japan

  • GSK Investigational Site

    Mexico City, 06700, Mexico

  • GSK Investigational Site

    Mexico City, 14080, Mexico

  • GSK Investigational Site

    Monterrey, 64020, Mexico

  • GSK Investigational Site

    Częstochowa, 42-217, Poland

  • GSK Investigational Site

    Katowice, 40-659, Poland

  • GSK Investigational Site

    Mysłowice, 41-400, Poland

  • GSK Investigational Site

    Warsaw, 03-712, Poland

  • GSK Investigational Site

    Wroclaw, 51-162, Poland

  • GSK Investigational Site

    Kemerovo, 650000, Russia

  • GSK Investigational Site

    Moscow, 119121, Russia

  • GSK Investigational Site

    Samara, 443063, Russia

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Madrid, 28007, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Seville, 41013, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Basingstoke, RG24 9NA, United Kingdom

  • GSK Investigational Site

    Glasgow, G31 2ER, United Kingdom

  • GSK Investigational Site

    London, NW3 2QG, United Kingdom

  • GSK Investigational Site

    Newcastle upon Tyne, NE4 5PL, United Kingdom

  • GSK Investigational Site

    Nottingham, NG7 2UH, United Kingdom

  • GSK Investigational Site

    Plymouth, PL6 8DH, United Kingdom

  • GSK Investigational Site

    Reading Berkshire, RG1 5AN, United Kingdom

  • GSK Investigational Site

    Southampton, SO16 6YD, United Kingdom

  • GSK Investigational Site

    Surrey, RH1 5RH, United Kingdom

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