Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)

Summary

Primary: To investigate the effect of treatment with oral linerixibat compared with placebo on itch in PBC patients with cholestatic pruritus over 24 weeks (Part A) Secondary: - To evaluate the early effects of oral linerixibat compared to placebo on itch in PBC patients with cholestatic pruritus (Part A) - To characterize the effects of treatment with oral linerixibat compared with placebo on health related QoL (Part A) - To evaluate the effects of 24 weeks of treatment with oral linerixibat compared to placebo on itch response rates in PBC patients with cholestatic pruritus (Part A) - To investigate the treatment effect of oral linerixibat compared with placebo on Patient?s Global Impression of Severity (PGI-S) and Patient?s Global Impression of Change (PGI-C) throughout the treatment period (Part A) - To evaluate the effects of treatment with linerixibat on markers of PBC disease activity and progression (Part A) Safety: To evaluate the safety of oral linerixibat compared with placebo (Part A and Part B) Exploratory: To investigate the improvement, maintenance, or return of itch (Part B)


Inclusion Criteria

  • 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.
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Study Location(s)

Beverly

More about this Clinical Trial

Full 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 .

Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

III

IRB Number

STUDY00001569

ClinicalTrials.gov ID

NCT04950127

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

III

IRB Number

212620-GLISTEN

ClinicalTrials.gov ID

NCT04950127

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?