Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

• Status: Recruiting
• Trial end date: 2023-06-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: GlaxoSmithKline

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:

• Symptoms suggestive of active coronavirus disease 2019 (COVID-19) infection whilst symptoms persist or known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days from the exposure.

• 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 actively replicating viral hepatitis B or C (HBV, HCV) 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 symptoms (e.g., atopic dermatitis, psoriasis).

• Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia.

• Current/previous diagnosis of colorectal cancer.

• 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.