Linerixibat Long-term Safety, and Tolerability Study (LLSAT)

June 17, 2026 updated by: GlaxoSmithKline

Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1061AAS
        • GSK Investigational Site
      • Capital Federal, Argentina, C1181ACI
        • GSK Investigational Site
      • Ciudad AutOnoma de Buenos Aire, Argentina, 1118
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentina, C1056ABI
        • GSK Investigational Site
      • Rosario, Argentina, S2002KDT
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
  • Brazil
      • Botucatu, Brazil, 18618686
        • GSK Investigational Site
      • Brasília, Brazil, 70335-900
        • GSK Investigational Site
      • Salvador, Brazil, 40110-160
        • GSK Investigational Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035003
        • GSK Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1618
        • GSK Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • GSK Investigational Site
  • China
      • Beijing, China, 100069
        • GSK Investigational Site
      • Beijing, China, 100032
        • GSK Investigational Site
      • Changchun, China, 130021
        • GSK Investigational Site
      • Chongqing, China, 400042
        • GSK Investigational Site
      • Guangzhou, China, 510630
        • GSK Investigational Site
      • Nanchang, China, 330006
        • GSK Investigational Site
      • Nanjing, China, 210003
        • GSK Investigational Site
      • Shanghai, China, 200127
        • GSK Investigational Site
      • Tianjin, China, 300000
        • GSK Investigational Site
  • Czechia
      • Pilsen, Czechia, 30100
        • GSK Investigational Site
      • Prague, Czechia, 140 21
        • GSK Investigational Site
  • France
      • Lille, France, 59037
        • GSK Investigational Site
  • Germany
      • Erlangen, Germany, 91054
        • GSK Investigational Site
      • Münster, Germany, 48149
        • GSK Investigational Site
  • Israel
      • Haifa, Israel, 34362
        • GSK Investigational Site
      • Holon, Israel, 58100
        • GSK Investigational Site
      • Jerusalem, Israel, 91120
        • GSK Investigational Site
      • Rehovot, Israel, 76100
        • GSK Investigational Site
  • Italy
      • Milan, Italy, 20142
        • GSK Investigational Site
      • Modena, Italy, 41126
        • GSK Investigational Site
      • Monza, Italy, 20900
        • GSK Investigational Site
      • Naples, Italy, 80131
        • GSK Investigational Site
      • Negrar Verona, Italy, 37024
        • GSK Investigational Site
      • Padova, Italy, 35128
        • GSK Investigational Site
      • Palermo, Italy, 90127
        • GSK Investigational Site
      • Roma, Italy, 00168
        • GSK Investigational Site
  • Japan
      • Chiba, Japan, 270-1694
        • GSK Investigational Site
      • Ehime, Japan, 791-0295
        • GSK Investigational Site
      • Fukui, Japan, 918-8503
        • GSK Investigational Site
      • Gunma, Japan, 371-8511
        • GSK Investigational Site
      • Hiroshima, Japan, 734-8551
        • GSK Investigational Site
      • Hiroshima, Japan, 730-8619
        • GSK Investigational Site
      • Hokkaido, Japan, 006-8555
        • GSK Investigational Site
      • Kagawa, Japan, 760-8557
        • GSK Investigational Site
      • Kanagawa, Japan, 259-1143
        • GSK Investigational Site
      • Nagano, Japan, 390-8621
        • GSK Investigational Site
      • Nagasaki, Japan, 856-8562
        • GSK Investigational Site
      • Nara, Japan, 634-8522
        • GSK Investigational Site
      • Osaka, Japan, 545-8586
        • GSK Investigational Site
      • Osaka, Japan, 591-8025
        • GSK Investigational Site
      • Shizuoka, Japan, 431-3192
        • GSK Investigational Site
      • Tokyo, Japan, 162-8655
        • GSK Investigational Site
      • Tokyo, Japan, 113-8603
        • GSK Investigational Site
      • Tokyo, Japan, 173-8606
        • GSK Investigational Site
      • Tokyo, Japan, 181-8611
        • GSK Investigational Site
  • Mexico
      • Mexico City, Mexico, 06700
        • GSK Investigational Site
      • Mexico City, Mexico, 14080
        • GSK Investigational Site
      • Monterrey, Mexico, 64020
        • GSK Investigational Site
  • Poland
      • Częstochowa, Poland, 42-217
        • GSK Investigational Site
      • Katowice, Poland, 40-659
        • GSK Investigational Site
      • Mysłowice, Poland, 41-400
        • GSK Investigational Site
      • Warsaw, Poland, 03-712
        • GSK Investigational Site
      • Wroclaw, Poland, 51-162
        • GSK Investigational Site
  • Russia
      • Kemerovo, Russia, 650000
        • GSK Investigational Site
      • Moscow, Russia, 119121
        • GSK Investigational Site
      • Samara, Russia, 443063
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Seville, Spain, 41013
        • GSK Investigational Site
      • Valencia, Spain, 46026
        • GSK Investigational Site
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • GSK Investigational Site
      • Glasgow, United Kingdom, G31 2ER
        • GSK Investigational Site
      • London, United Kingdom, NW3 2QG
        • GSK Investigational Site
      • Newcastle upon Tyne, United Kingdom, NE4 5PL
        • GSK Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • GSK Investigational Site
      • Plymouth, United Kingdom, PL6 8DH
        • GSK Investigational Site
      • Reading Berkshire, United Kingdom, RG1 5AN
        • GSK Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • GSK Investigational Site
      • Surrey, United Kingdom, RH1 5RH
        • GSK Investigational Site
  • United States
    • California
      • Davis, California, United States, 95817
        • GSK Investigational Site
      • West Hollywood, California, United States, 90048
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48377
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10016
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Morrisville, North Carolina, United States, 27560
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants receiving linerixibat
Participants who previously participated in the Phase 2 studies (BAT117213 and 201000 GLIMMER [Group 1]) and Phase 3 study (212620 GLISTEN [Group 2]), will receive linerixibat.
Drug: Linerixibat
All participants will receive linerixibat.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)
Time Frame: Up to 66 months
AEs and SAEs will be collected.
Up to 66 months
Number of participants with Severe AEs
Time Frame: Up to 66 months
AEs and SAEs will be collected.
Up to 66 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in domain scores of the PBC-40 over time
Time Frame: Baseline and up to 65 months
The PBC-40 is a participant-derived, disease specific health-related quality of life (QoL) measure with data to support its validity in PBC. The PBC-40 measure is comprised of 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact) grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional).
Baseline and up to 65 months
Change in health-related quality of life (QoL) by the Euro Quality-5 dimension-3 level (EQ-5D-3L) scores over time (Group 1 only)
Time Frame: Baseline and up to 65 months
The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ Visual Analogue Scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, and 3=extreme problems.
Baseline and up to 65 months
Change in self-rated health by EQ VAS scores over time (Group 1 only)
Time Frame: Baseline and up to 65 months
The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ VAS records self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Baseline and up to 65 months
Change in the Beck Depression Inventory (BDI-II) scores over time
Time Frame: Baseline and up to 65 months
The BDI-II is a 21-item questionnaire used to assess the intensity of depression in clinical and normal participants. Each item is scored from 0 (Normal) to 3 (Severe). The total score on the BDI-II ranges from 0-63, with higher scores reflecting higher levels of depression.
Baseline and up to 65 months
Number of participants with clinically significant changes in hematology, biochemistry (including lipid and liver parameters), and coagulation parameters
Time Frame: Baseline and up to 65 months
Blood samples will be collected for the analysis of hematology, biochemistry (including lipid and liver parameters) and coagulation parameters.
Baseline and up to 65 months
Percentage of responders at Week 24 and Week 52 of continuous treatment (Group 2 only)
Time Frame: Week 24 and Week 52 of continuous treatment
Monthly Itch Score (MIS) will be assessed using an numerical rating scale (NRS), ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Response thresholds of greater than or equal to (>=) 2, >=3, and >=4-point reduction in MIS will be assessed.
Week 24 and Week 52 of continuous treatment
Percentage of participants with maintenance of efficacy at Week 52 of continuous treatment in those that were responders at Week 24 of continuous treatment (Group 2 only)
Time Frame: Week 52 of continuous treatment
The MIS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Maintenance of efficacy occurs when a participant is a responder (>=2, >=3, and >=4-point reduction in MIS) at Week 24 of continuous treatment and is also a responder at Week 52 of continuous treatment.
Week 52 of continuous treatment
Change from Baseline Monthly Sleep Score (MSS) (Group 2 only)
Time Frame: Baseline and up to Week 52 of continuous treatment
The MSS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. This will be assessed at Week 52 of continuous treatment.
Baseline and up to Week 52 of continuous treatment
Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only)
Time Frame: Baseline and up to Week 52 of continuous treatment
The MFS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no fatigue and 10 the worst possible fatigue. This will be assessed at Week 52 of continuous treatment.
Baseline and up to Week 52 of continuous treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 212358
  • 2019-003158-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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