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).
Brief description of study
This study is a Phase 3, multicenter, 2-part (Part A and Part B), randomized, double-blind, placebo-controlled study in PBC patients with moderate to severe pruritus. Part A will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo over 24 weeks, while Part B will assess the return of itch over 8 weeks after withdrawal of linerixibat. In both Part A and Part B, participants may be treatment naïve, have had prior itch therapy and/or may take stable background itch therapy at the discretion of the physician in the best interest of the patient or rescue medication where applicable. This study consists of four Periods (Screening, Intervention (Part A and Part B) and Follow-up)
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