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Bile Acid Sequestrant

Linerixibat for Itching in Cholangitis

Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have moderate to severe itch
Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights

Study Summary

This trial will compare the effects of linerixibat to placebo in people with primary biliary cholangitis and itchiness.

Who is the study for?
This trial is for adults aged 18-80 with Primary Biliary Cholangitis (PBC) who suffer from moderate to severe itching. Candidates must have documented PBC and cannot have certain liver complications, changes in itch medication within the last 8 weeks, primary sleep disorders, or active viral infections among other exclusions.Check my eligibility
What is being tested?
The GLISTEN study is testing the effectiveness and safety of a drug called Linerixibat against a placebo in relieving itch caused by PBC. It also looks at how this treatment affects patients' quality of life.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical drug reactions such as gastrointestinal issues, skin reactions, or abnormal blood tests reflecting liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience moderate to severe itching.
Select...
I am between 18 and 80 years old.
Select...
I experience moderate to severe itching.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Monthly Itch Scores over 24 weeks using Numerical Rating Scale (NRS)
Secondary outcome measures
Change from Baseline in Monthly Sleep Score as measured by NRS over 24 weeks
Change from Baseline in Patient's Global Impression of Severity (PGI-S) over 24 weeks
Change from Baseline in Primary Biliary Cholangitis-40 (PBC-40) domain scores at Week 24
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving placebo followed by linerixibatExperimental Treatment2 Interventions
Group II: Participants receiving linerixibat followed by placeboExperimental Treatment2 Interventions
Group III: Participants receiving linerixibatExperimental Treatment1 Intervention
Group IV: Participants receiving placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Linerixibat
2022
Completed Phase 1
~60
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,753 Previous Clinical Trials
8,069,458 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,700 Total Patients Enrolled

Media Library

Linerixibat (Bile Acid Sequestrant) Clinical Trial Eligibility Overview. Trial Name: NCT04950127 — Phase 3
Itching Research Study Groups: Participants receiving linerixibat, Participants receiving placebo followed by linerixibat, Participants receiving linerixibat followed by placebo, Participants receiving placebo
Itching Clinical Trial 2023: Linerixibat Highlights & Side Effects. Trial Name: NCT04950127 — Phase 3
Linerixibat (Bile Acid Sequestrant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04950127 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include individuals who are under the age of 55?

"To be eligible for this clinical trial, applicants must between 18-80 years old. If you are not within that age bracket, there are 72 other trials you may be eligible for."

Answered by AI

What is the Linerixibat success rate in the US?

"There is some evidence efficacy and multiple rounds of data supporting safety, thus our team has given Linerixibat a score of 3."

Answered by AI

If I qualify, who can I speak to about enrolling in the research?

"Researchers conducting this trial are in need of 230 individuals aged 18 to 80 years old that experience pruritus. Additionally, it is imperative that these participants suffer from moderate to severe itch."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
2021. "Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04950127.
All > Liver Cirrhosis
~36 spots leftby Oct 2024
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