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COMPLETED
NCT04950127
PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

238

Start Date

2021-08-27

Completion Date

2024-12-20

Last Updated

2026-07-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Linerixibat

Participants will receive linerixibat.

DRUG

Placebo

Participants will receive placebo.

Locations (5)

GSK Investigational Site

Erlangen, Germany

GSK Investigational Site

Münster, Germany

GSK Investigational Site

Cambridge, United Kingdom

GSK Investigational Site

Durham, United Kingdom

GSK Investigational Site

Newcastle upon Tyne, United Kingdom