Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
NCT ID: NCT04950127
Last Updated: 2025-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
238 participants
INTERVENTIONAL
2021-08-27
2024-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part A: Linerixibat 40 milligrams (mg)
Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).
Linerixibat
Participants will receive linerixibat.
Part A: Placebo
Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Linerixibat
Participants will receive linerixibat.
Placebo
Participants will receive placebo.
Part B: Placebo in Part A and Part B
Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.
Placebo
Participants will receive placebo.
Part B: Placebo in Part A and Linerixibat 40 mg in Part B
Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.
Linerixibat
Participants will receive linerixibat.
Placebo
Participants will receive placebo.
Part B: Linerixibat 40 mg in Part A and Placebo in Part B
Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.
Linerixibat
Participants will receive linerixibat.
Placebo
Participants will receive placebo.
Part B: Linerixibat 40 mg in Part A and Part B
Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.
Linerixibat
Participants will receive linerixibat.
Interventions
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Linerixibat
Participants will receive linerixibat.
Placebo
Participants will receive placebo.
Eligibility Criteria
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Inclusion Criteria
* Participants who have documented PBC.
* Participants who have moderate to severe itch.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Davis, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Colorado Springs, Colorado, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Detroit, Michigan, United States
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Jackson, Mississippi, United States
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Omaha, Nebraska, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Morrisville, North Carolina, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Buenos Aires, , Argentina
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Capital Federal, , Argentina
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Ciudad AutOnoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Bueno, , Argentina
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Rosario, , Argentina
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San Nicolás, , Argentina
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Santa Fe, , Argentina
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Ghent, , Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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Botucatu, , Brazil
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Brasília, , Brazil
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Salvador, , Brazil
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Edmonton, Alberta, Canada
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Toronto, Ontario, Canada
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Chongqing, , China
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Guangzhou, , China
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Nanchang, , China
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Nanjing, , China
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Shanghai, , China
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Tianjin, , China
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Zhanjiang, , China
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Ostrava, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Créteil, , France
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Grenoble, , France
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Lille, , France
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Paris, , France
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Erlangen, , Germany
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Essen, , Germany
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Münster, , Germany
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Athens, , Greece
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Beersheba, , Israel
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Nahariya, , Israel
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Rehovot, , Israel
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Milan, , Italy
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Modena, , Italy
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Monza, , Italy
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Napoli, , Italy
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Negrar Verona, , Italy
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Palermo, , Italy
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Roma, , Italy
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Rozzano MI, , Italy
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Ehime, , Japan
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Fukui, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Ibaraki, , Japan
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Kagawa, , Japan
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Kanagawa, , Japan
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Nagano, , Japan
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Nagasaki, , Japan
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Nara, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Mexico City, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Częstochowa, , Poland
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Katowice, , Poland
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Mysłowice, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Samara, , Russia
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Basingstoke, , United Kingdom
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Cambridge, , United Kingdom
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Durham, , United Kingdom
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Hull, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Plymouth, , United Kingdom
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Reading Berkshire, , United Kingdom
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Southampton, , United Kingdom
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Surrey, , United Kingdom
Countries
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References
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Carreno F, Karatza E, Mehta R, Collins J, Austin D, Swift B. Population Dose-Response-Time Analysis of Itch Reduction and Patient-Reported Tolerability Supports Phase III Dose Selection for Linerixibat. Clin Pharmacol Ther. 2024 Feb;115(2):288-298. doi: 10.1002/cpt.3103. Epub 2023 Dec 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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212620
Identifier Type: -
Identifier Source: org_study_id
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