Linerixibat Long-term Safety, and Tolerability Study

• Status: Recruiting
• Trial end date: 2025-12-23
• Target enrollment: 0
• Participant gender: All

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 duration of the study will be approximately four years until study end, however the total duration of study participation will vary by participant depending upon time of entry relative to study end in their respective country.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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 not a woman of childbearing potential (WOCBP) or b) is a WOCBP and using a contraceptive method that is highly effective.

• 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.

• History or 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 study withdrawal.

• Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening.

• QT interval corrected (QTc) >480 millisecond (msec) at screening (12-lead ECG)

• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 units for males or >7 units for females.