Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
Phase 3
Completed
NCT04950127
| Condition | Pruritus |
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| Phase | Phase 3 |
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| Sponsor | GlaxoSmithKline |
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| Status | Completed |
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| Enrollment | 238 participants |
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| Interventions | Linerixibat |
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| Start date | Aug 27, 2021 |
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| Completion date | Oct 28, 2024 |
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| Results posted | Jul 22, 2025 |
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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.
Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS)
Baseline and up to Week 24 · Scores on a scale
| Part A: Linerixibat 40 Milligrams (mg) | -2.86 Scores on a scale |
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| Part A: Placebo | -2.15 Scores on a scale |
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| p-value | 0.001 |
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| Mean Difference (Net) | -0.72 (95% CI -1.15–-0.28) |
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Open in BENITIONS
View on ClinicalTrials.gov
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