Last updated: 11/18/2025 05:14:34
Global linerixibat Itch study of efficacy and safety in primary biliary cholangitis (PBC) (GLISTEN)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC)
Trial description: This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Part A: Mean Change from Baseline in Monthly Itch Scores over 24 weeks using Numerical Rating Scale (NRS)
Timeframe: Baseline and up to Week 24
Secondary outcomes:
Part A: Mean Change from Baseline in Weekly Itch Score at Week 2 using NRS
Timeframe: Baseline and at Week 2
Part A: Mean Change from Baseline in Monthly Sleep Score over 24 weeks using NRS
Timeframe: Baseline up to Week 24
Part A: Percentage of Responders Defined as Achieving more than or equal to (>=) 2-point Reduction from Baseline in the Monthly Itch Score at Week 24
Timeframe: At Week 24
Part A: Percentage of Responders Achieving >=3-point reduction from baseline in the Monthly Itch Score at Week 24
Timeframe: At Week 24
Part A: Percentage of Responders as Achieving a >=4-point Reduction from Baseline in the Monthly Itch Score at Week 24
Timeframe: At Week 24
Part A: Mean Change from Baseline in Primary Biliary Cholangitis-40 (PBC-40) domain scores at Week 24
Timeframe: Baseline up to Week 24
Part A: Mean Change from Baseline in Patient's Global Impression of Severity (PGI-S) over 24 weeks
Timeframe: Baseline and up to Week 24
Part A: Patient's Global Impression of Change (PGI-C) scores over 24 weeks
Timeframe: Week 4 up to Week 24
Part A: Mean change from Baseline in Alkaline Phosphatase (ALP) at Week 24
Timeframe: Baseline and Week 24
Part A: Mean Change from Baseline in Bilirubin at Week 24
Timeframe: Baseline and Week 24
Interventions:
Enrollment:
238
Primary completion date:
2024-28-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gideon M Hirschfield, Christopher L Bowlus, David E J Jones, Andreas E Kremer, Marlyn J Mayo, Atsushi Tanaka, Pietro Andreone, Jidong Jia, Qinglong Jin, Ricardo U Macías-Rodríguez, Alexander R Cobitz, Brooke M Currie, Ciara Gorey, Ivana Lazic, Danielle Podmore, Andrea Ribeiro, Jennifer B Shannon, Brandon Swift, Megan M McLaughlin, Cynthia Levy. Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. The Lancet Gastroenterology & Hepatology. 2025-10; doi:10.1016/S2468-1253(25)00192-X https://doi.org/10.1016/s2468-1253(25)00192-x
PMID: 41173016
DOI: 10.1016/S2468-1253(25)00192-X
Medical condition
Pruritus
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2021 to December 2024
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina, C1056ABI
Status
Study Complete
Location
GSK Investigational Site
Reading Berkshire, United Kingdom, RG1 5AN
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, CO, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, Argentina, 1118
Status
Study Complete
Location
GSK Investigational Site
NEWCASTLE UPON TYNE, United Kingdom, NE4 6BE
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, PA, United States, 19104
Status
Study Complete
Location
GSK Investigational Site
San Francisco, CA, United States, 94143
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, NM, United States, 87109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, MA, United States, 02215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Houston, TX, United States, 77054
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, CA, United States, 90033
Status
Terminated/Withdrawn
Location
GSK Investigational Site
MONTPELLIER CEDEX 5, France, 34295
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, FL, United States, 32825
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rio de Janeiro, Brazil, 21941-617
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint-Petersburg, Russia, 197110
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tamarac, FL, United States, 33321
Status
Terminated/Withdrawn
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2024-28-10
Actual study completion date
2024-20-12
Plain language summaries
Summary of results in plain language
Available language(s): English, Bulgarian, Czech, Dutch (Belgium), French (Belgium), French (Canadian), French, German, Greek, Hebrew, Italian, Japanese, Polish, Portuguese (Brazil), Russian (Israel), Russian, Chinese (Simplified), Spanish (Argentina), Spanish (Mexico), Spanish, Spanish (United States)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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