NCT04167358

Linerixibat Long-term Safety, and Tolerability Study

Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 \[NCT01899703\], 201000 GLIMMER \[NCT02966834\] (group 1) or 212620 GLISTEN \[NCT00210418\]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

Conditions

• Cholestasis

Interventions

Type	Name	Description
DRUG	Linerixibat	All participants will receive linerixibat.

Timeline

• Start date: 2020-07-14
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2019-11-18
• Last updated: 2026-02-20

Locations

89 sites across 17 countries: United States, Argentina, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Israel, Italy, Japan, Mexico, Poland, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study