Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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.