Trial · NCT04950127
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
NCT04950127, Phase 3, Completed, GlaxoSmithKline; results first posted 2025-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN). Trials, record NCT04950127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04950127
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
- NCT number
- NCT04950127
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 238 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pruritus
- Interventions
- Linerixibat, Placebo
- First posted
- 2021-07-06
- Last updated
- 2026-07-22
- Results first posted
- 2025-07-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS) | Baseline and up to Week 24 | Itch Scores were assessed using a NRS twice daily, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. The monthly itch score was defined as the worst weekly itch score for the month (4 weeks). Higher monthly itch scores indicate worse itching. Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. Least-squares (LS) means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly itch scores obtained over 24 weeks using equal weighting for all time points. Analyzed using Mixed Model Repeated Measures (MMRM) method. |
| Secondary | Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS | Baseline and at Week 2 | Itch Score was assessed using a twice daily NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The worst daily itch score was defined as the worst of the two scores recorded daily. The weekly itch score was defined as the average of the worst daily itch scores in one week. Higher weekly itch scores indicate worse itching. Baseline is the average of the Worst Daily Itch scores in the 7 days prior to randomization (Day 1). Change from Baseline is defined as the Week 2 value minus baseline value. Key secondary endpoints were tested in a step-down/hierarchical approach. Mean Change from Baseline in Weekly Itch Score at Week 2 was the first endpoint tested in the hierarchical analysis. LS mean and the corresponding 95% confidence intervals are reported using Mixed Model Repeated Measures (MMRM) method. |
| Secondary | Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS | Baseline up to Week 24 | Sleep Scores were assessed using an NRS scale, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. The weekly sleep scale is the average of the daily sleep scores for each week. The monthly sleep score was defined as the worst weekly sleep score for the month (4 weeks). Higher monthly sleep scores indicate higher impact on sleep. Baseline is the worst Weekly Sleep Score in the 28 days prior to randomization (Day 1). Change from Baseline is defined as the post dose value minus baseline value. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in monthly sleep scores obtained over 24 weeks using equal weighting for all time points analyzed using Mixed Model Repeated Measures (MMRM) method. Mean Change from Baseline in Monthly Sleep Score over 24 weeks was the second endpoint tested in the hierarchical analysis. |
| Secondary | Part A: Percentage of Responders Defined as Achieving More Than or Equal to (>=) 2-point Reduction From Baseline in the Monthly Itch Score at Week 24 | At Week 24 | Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization (Day 1). Responders were defined as participants achieving \>=2-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \>= 2-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the third endpoint tested in the hierarchical analysis. |
| Secondary | Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score at Week 24 | At Week 24 | Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization. Responders were defined as participants achieving \>=3-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \>= 3-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the fourth endpoint to be tested in the hierarchical analysis. |
| Secondary | Part A: Percentage of Responders as Achieving a >=4-point Reduction From Baseline in the Monthly Itch Score at Week 24 | At Week 24 | Monthly Itch Score was assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. The Monthly Itch Score was determined from the worst weekly itch score for the month (4 weeks). Baseline is the worst weekly itch score in the 28 days prior to randomization. Responders were defined as participants achieving \>=4-point reduction (improvement) from baseline in the Monthly Itch Score. Percentage of Responders achieving \>= 4-point Reduction from Baseline in the Monthly Itch Score at Week 24 was the fifth endpoint to be tested in the hierarchical analysis. |
| Secondary | Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24 | Baseline up to Week 24 | PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire validated for use in participants with PBC. It consists of 40 questions, which are grouped into 6 domains with 3 to 11 questions per domain. Each question is scored from 1 (least impact) to 5 (greatest impact). For all questions, an answer of "Does/Did not apply" was scored 0. All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 6 to 35, Itch (3 questions) with score range 0 to 15, Fatigue (11 questions) with score range 11 to 55 , Cognitive (6 questions) with score range 6 to 30 , Emotional (3 questions) with score range 3 to 15 and Social (10 questions) with score range 8 to 50 . Higher scores for individual domains represent poorer quality of life. Baseline is the last assessment prior to the first dose of randomized treatment (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value. |
| Secondary | Part A: Mean Change From Baseline in Patient's Global Impression of Severity (PGI-S) Over 24 Weeks | Baseline and up to Week 24 | The Patient's Global Impression of Severity (PGI-S) is a patient-reported outcome measure used to assess the severity of symptoms from the participant's perspective. The PGI-S asks participant to rate the severity of their itch in the past 7 days on a single item, using a scale ranging from 0 (absent) to 5 (very severe). Higher score indicates higher severity. Baseline is the last assessment prior to the first dose of randomized treatment for Part A (Day 1). Change from Baseline is defined as the post dose value minus baseline value. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of change from baseline in PGI-S obtained over 24 weeks using equal weighting for all time points, analyzed using Mixed Model Repeated Measures (MMRM) method. |
| Secondary | Part A: Patient's Global Impression of Change (PGI-C) Scores Over 24 Weeks | Week 4 up to Week 24 | Patient's Global Impression of Change (PGI-C) was assessed using a 7-level response scale, ranging from 1 (very much improved) to 7 (very much worse). Higher score indicates higher level of change. LS means and the corresponding 95% confidence intervals are reported by taking average of LS means of PGI-C obtained over 24 weeks using equal weighting for all timepoints, analyzed using Mixed Model Repeated Measures (MMRM) method. |
| Secondary | Part A: Mean Change From Baseline in Alkaline Phosphatase (ALP) at Week 24 | Baseline and Week 24 | Blood samples were collected at indicated time points for evaluation of ALP. Change from Baseline in ALP at Week 24 was evaluated. Baseline was established using an average of two sets of laboratory values obtained at least 4 weeks apart within 56 days prior to randomization (Day 1). Change from Baseline was calculated as Week 24 value minus Baseline value. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS) | Baseline and up to Week 24 | The analysis was performed on the Intent to Treat (ITT) set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS | Baseline and at Week 2 | The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS | Baseline up to Week 24 | The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Percentage of Responders Defined as Achieving More Than or Equal to (>=) 2-point Reduction From Baseline in the Monthly Itch Score at Week 24 | At Week 24 | The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score at Week 24 | At Week 24 | The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Responders as Achieving a >=4-point Reduction From Baseline in the Monthly Itch Score at Week 24 | At Week 24 | The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Percentage values were rounded to the nearest whole number. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at Week 24 | Baseline up to Week 24 | ITT population set included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Number of Participants Analyzed (N) was the maximum number of participants analyzed for any domain, while Number analyzed (n) was the number of participants included in the model for each domain. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Patient's Global Impression of Severity (PGI-S) Over 24 Weeks | Baseline and up to Week 24 | The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Patient's Global Impression of Change (PGI-C) Scores Over 24 Weeks | Week 4 up to Week 24 | The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data for at least one time point were included. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Alkaline Phosphatase (ALP) at Week 24 | Baseline and Week 24 | The analysis was performed on the ITT set that included all randomized participants. Participants in the ITT Population were classified according to the treatment as randomized. Only participants with data at baseline and at least one post-baseline time point were included. | International units per liter (IU/L) | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS) | Part A: Linerixibat 40 Milligrams (mg) | -2.86 | 95% Confidence Interval -3.23 to -2.50 | Scores on a scale | |
| Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS) | Part A: Placebo | -2.15 | 95% Confidence Interval -2.51 to -1.78 | Scores on a scale | |
| Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS | Part A: Linerixibat 40 Milligrams (mg) | -1.78 | 95% Confidence Interval -2.08 to -1.48 | Scores on a scale | |
| Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS | Part A: Placebo | -1.07 | 95% Confidence Interval -1.37 to -0.77 | Scores on a scale | |
| Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS | Part A: Linerixibat 40 Milligrams (mg) | -2.77 | 95% Confidence Interval -3.15 to -2.38 | Scores on a scale | |
| Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS | Part A: Placebo | -2.24 | 95% Confidence Interval -2.62 to -1.86 | Scores on a scale | |
| Part A: Percentage of Responders Defined as Achieving More Than or Equal to (>=) 2-point Reduction From Baseline in the Monthly Itch Score at Week 24 | Part A: Linerixibat 40 Milligrams (mg) | 68.0 | Percentage of participants | ||
| Part A: Percentage of Responders Defined as Achieving More Than or Equal to (>=) 2-point Reduction From Baseline in the Monthly Itch Score at Week 24 | Part A: Placebo | 64.0 | Percentage of participants | ||
| Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score at Week 24 | Part A: Linerixibat 40 Milligrams (mg) | 56.0 | Percentage of participants | ||
| Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score at Week 24 | Part A: Placebo | 43.0 | Percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Day 1 to Week 24) | STARTED | Part A: Linerixibat 40 Milligrams (mg) | 119 | |
| Part A (Day 1 to Week 24) | STARTED | Part A: Placebo | 119 | |
| Part A (Day 1 to Week 24) | STARTED | Part B: Placebo in Part A and Part B | 0 | |
| Part A (Day 1 to Week 24) | STARTED | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | 0 | |
| Part A (Day 1 to Week 24) | STARTED | Part B: Linerixibat 40 mg in Part A and Placebo in Part B | 0 | |
| Part A (Day 1 to Week 24) | STARTED | Part B: Linerixibat 40 mg in Part A and Part B | 0 | |
| Part A (Day 1 to Week 24) | Safety Population | Part A: Linerixibat 40 Milligrams (mg) | 119 | |
| Part A (Day 1 to Week 24) | Safety Population | Part A: Placebo | 118 | |
| Part A (Day 1 to Week 24) | Safety Population | Part B: Placebo in Part A and Part B | 0 | |
| Part A (Day 1 to Week 24) | Safety Population | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events234
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: Placebo | 7 | 118 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Linerixibat 40 Milligrams (mg) | 2 | 119 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Placebo in Part A and Part B | 0 | 53 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | 0 | 52 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Linerixibat 40 mg in Part A and Placebo in Part B | 0 | 46 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Linerixibat 40 mg in Part A and Part B | 0 | 45 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part A: Placebo | 6 | 118 | 6 |
| other | Abdominal distension | Gastrointestinal disorders | Part A: Linerixibat 40 Milligrams (mg) | 8 | 119 | 10 |
| other | Abdominal distension | Gastrointestinal disorders | Part B: Placebo in Part A and Part B | 0 | 53 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | 0 | 52 | 0 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Placebo | 0 | 118 |
| Total, all-cause mortality | Part A: Linerixibat 40 Milligrams (mg) | 0 | 119 |
| Total, all-cause mortality | Part B: Placebo in Part A and Part B | 0 | 53 |
| Total, all-cause mortality | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | 0 | 52 |
| Total, all-cause mortality | Part B: Linerixibat 40 mg in Part A and Placebo in Part B | 0 | 46 |
| Total, all-cause mortality | Part B: Linerixibat 40 mg in Part A and Part B | 0 | 45 |
| Total, other adverse events | Part A: Placebo | 54 | 118 |
| Total, other adverse events | Part A: Linerixibat 40 Milligrams (mg) | 96 | 119 |
| Total, other adverse events | Part B: Placebo in Part A and Part B | 5 | 53 |
| Total, other adverse events | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | 16 | 52 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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