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ACTIVE NOT RECRUITING

NCT04167358

PHASE3

Linerixibat Long-term Safety, and Tolerability Study

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

242

Start Date

2020-07-14

Completion Date

2026-09-30

Last Updated

2026-02-20

Healthy Volunteers

Conditions

Cholestasis

Interventions

DRUG

Linerixibat

All participants will receive linerixibat.

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.

Locations (89)

GSK Investigational Site

Davis, California, United States

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West Hollywood, California, United States

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Miami, Florida, United States

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Detroit, Michigan, 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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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Seattle, Washington, 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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Santa Fe, Argentina

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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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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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Pilsen, Czechia

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Prague, Czechia

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Lille, France

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Erlangen, Germany

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Münster, Germany

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Haifa, Israel

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Holon, Israel

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Jerusalem, Israel

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Naples, Italy

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Negrar Verona, Italy

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Palermo, Italy

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Roma, Italy

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Chiba, Japan

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Ehime, Japan

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Fukui, Japan

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Gunma, Japan

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Hiroshima, Japan

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Hiroshima, Japan

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Hokkaido, 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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Osaka, Japan

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Osaka, 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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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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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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Valencia, Spain

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Basingstoke, United Kingdom

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Glasgow, United Kingdom

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London, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Nottingham, 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

Clinical Research Directory

Linerixibat Long-term Safety, and Tolerability Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (89)