A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)

CompletadoFase 3ClinicalTrials.gov

ID: NCT04950127Tipo: INTERVENTIONALInicio: 27 de ago de 2021Fin estimado: 20 de dic de 2024

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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 HBsAg positive hepatitis B or hepatitis C (HCV) (anti-HCV and Ribonucleic 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 disease according 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 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.

Intervenciones

drug

Linerixibat

Participants will receive linerixibat.

drug

Placebo

Participants will receive placebo.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Argentina

GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

San Nicolás, Argentina

GSK Investigational Site

Santa Fe, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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