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

Inclusion Criteria:

• Male and female participants must be between 18 to 80 years of age inclusive, at thetime 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 twoBaseline measures.

• Screening Alanine Aminotransferase (ALT) > 6 times ULN in a single Baseline measureor 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, hepaticencephalopathy or ascites).

• Presence of HBsAg positive hepatitis B or hepatitis C (HCV) (anti-HCV andRibonucleic 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 diseaseaccording 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 notinitiate or restart during the study).

• Initiation, discontinuation, or change in dose of any of the following in the 8weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone,naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selectiveserotonin reuptake inhibitor (SSRIs), antihistamines used for the treatment ofitching.

• Administration of any other human ileal bile acid transporter (IBAT) inhibitor inthe 12 weeks prior to screening.

• Any planned procedures intended to treat cholestatic pruritus such as nasobiliarydrainage or ultraviolet light therapy from Screening and throughout the study.

• History of sensitivity or intolerance to the study treatment.