A Phase 3 interventional study of Linerixibat and Placebo in Pruritus, sponsored by GlaxoSmithKline. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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.
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's enrollment of 238 is above the median of 60 across 422 interventional studies indexed under Pruritus.
Browse Pruritus studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) in Part A (up to Week 24).
Drug: Linerixibat
Participants were randomized to receive Placebo orally twice a day (BID) in Part A (up to Week 24).
Drug: Linerixibat · Drug: Placebo
Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, continued to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.
Drug: Placebo
Participants who were randomized to receive Placebo (up to Week 24) orally twice a day (BID) in Part A, switched to receive linerixibat 40 mg tablet orally twice a day (BID) (from Week 24 to Week 32) in Part B.
Drug: Linerixibat · Drug: Placebo
Participants who were randomized to receive linerixibat 40 mg tablet orally BID (up to Week 24) in Part A, switched to receive Placebo (from Week 24 to Week 32) orally twice a day (BID) in Part B.
Drug: Linerixibat · Drug: Placebo
Participants who were randomized to receive linerixibat 40 mg tablet orally twice a day (BID) (up to Week 24) in Part A, continued to receive linerixibat 40 mg twice a day (BID) (from Week 24 to Week 32) in Part B.
Drug: Linerixibat
Participants will receive linerixibat.
Participants will receive placebo.
Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS)
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.
Time frame: Baseline and up to Week 24
Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS
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.
Time frame: Baseline and at Week 2
Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS
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.
Time frame: Baseline up to Week 24
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
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.
Time frame: At Week 24
Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score 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.
Time frame: At Week 24
Part A: Percentage of Responders as Achieving a >=4-point Reduction From Baseline in the Monthly Itch Score 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.
Time frame: At Week 24
Part A: Mean Change From Baseline in Primary Biliary Cholangitis-40 (PBC-40) Domain Scores at 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.
Time frame: Baseline up to Week 24
Part A: Mean Change From Baseline in Patient's Global Impression of Severity (PGI-S) Over 24 Weeks
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.
Time frame: Baseline and up to Week 24
Part A: Patient's Global Impression of Change (PGI-C) Scores Over 24 Weeks
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.
Time frame: Week 4 up to Week 24
Part A: Mean Change From Baseline in Alkaline Phosphatase (ALP) at 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.
Time frame: Baseline and Week 24
Part A: Mean Change From Baseline in Bilirubin at Week 24
Blood samples were collected at indicated time points for evaluation of Bilirubin. Change from Baseline in total bilirubin 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.
Time frame: Baseline and Week 24
A total of 238 participants from Europe, North America, Latin America and Asia were enrolled and randomized.
| Milestone | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo | Part B: Placebo in Part A and Part B | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | Part B: Linerixibat 40 mg in Part A and Placebo in Part B | Part B: Linerixibat 40 mg in Part A and Part B |
|---|---|---|---|---|---|---|
| Started | 119 | 119 | 0 | 0 | 0 | 0 |
| Safety population | 119 | 118 | 0 | 0 | 0 | 0 |
| Completed | 103 | 108 | 0 | 0 | 0 | 0 |
| Not completed | 16 | 11 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 4 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 3 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 9 | 7 | 0 | 0 | 0 | 0 |
| Milestone | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo | Part B: Placebo in Part A and Part B | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | Part B: Linerixibat 40 mg in Part A and Placebo in Part B | Part B: Linerixibat 40 mg in Part A and Part B |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 55 | 53 | 49 | 54 |
| Safety population | 0 | 0 | 53 | 52 | 46 | 45 |
| Completed | 0 | 0 | 55 | 53 | 49 | 49 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 5 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 4 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 1 |
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.
| Scores on a scale | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS) | -2.86 (-3.23 to -2.50) | -2.15 (-2.51 to -1.78) |
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.
| Scores on a scale | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Mean Change From Baseline in Weekly Itch Score at Week 2 Using NRS | -1.78 (-2.08 to -1.48) | -1.07 (-1.37 to -0.77) |
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.
| Scores on a scale | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Mean Change From Baseline in Monthly Sleep Score Over 24 Weeks Using NRS | -2.77 (-3.15 to -2.38) | -2.24 (-2.62 to -1.86) |
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.
| Percentage of participants | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| 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 | 68.0 | 64.0 |
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.
| Percentage of participants | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Percentage of Responders Achieving >=3-point Reduction From Baseline in the Monthly Itch Score at Week 24 | 56.0 | 43.0 |
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.
| Percentage of participants | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Percentage of Responders as Achieving a >=4-point Reduction From Baseline in the Monthly Itch Score at Week 24 | 41.0 | 29.0 |
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.
| Scores on a scale | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Cognitive (score range: 6 to 30) | -0.71 (-1.60 to 0.18) | -1.47 (-2.36 to -0.58) |
| Emotional (score range: 3 to 15) | -1.07 (-1.57 to -0.57) | -1.34 (-1.83 to -0.84) |
| Fatigue (score range: 11 to 55) | -2.94 (-4.63 to -1.26) | -4.54 (-6.21 to -2.86) |
| Itch (score range: 0 to 15) | -3.47 (-4.08 to -2.86) | -2.89 (-3.50 to -2.28) |
| Social (score range: 8 to 50) | -2.57 (-3.71 to -1.43) | -2.42 (-3.56 to -1.29) |
| Symptoms (score range: 6 to 35) | 0.54 (-0.18 to 1.25) | 0.08 (-0.62 to 0.79) |
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.
| Scores on a scale | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Mean Change From Baseline in Patient's Global Impression of Severity (PGI-S) Over 24 Weeks | -1.22 (-1.36 to -1.07) | -0.84 (-0.99 to -0.70) |
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.
| Scores on a scale | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Patient's Global Impression of Change (PGI-C) Scores Over 24 Weeks | 1.97 (1.74 to 2.20) | 2.46 (2.23 to 2.69) |
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.
| International units per liter (IU/L) | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Mean Change From Baseline in Alkaline Phosphatase (ALP) at Week 24 | 10.61 (-8.53 to 29.74) | -8.03 (-26.79 to 10.74) |
Blood samples were collected at indicated time points for evaluation of Bilirubin. Change from Baseline in total bilirubin 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.
| Micromoles per Liter (mmol/L) | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo |
|---|---|---|
| Part A: Mean Change From Baseline in Bilirubin at Week 24 | 1.77 (0.84 to 2.71) | -0.31 (-1.24 to 0.62) |
Collected over SAEs were collected from the signing of informed consent until last visit (Week 32) or follow up phone call. AEs were collected from start of treatment until last visit (Week 32) or follow up phone call.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: Placebo | 0/118 (0%) | 4/118 (3.4%) | 54/118 (45.8%) |
| Part A: Linerixibat 40 Milligrams (mg) | 0/119 (0%) | 14/119 (11.8%) | 96/119 (80.7%) |
| Part B: Placebo in Part A and Part B | 0/53 (0%) | 0/53 (0%) | 5/53 (9.4%) |
| Part B: Placebo in Part A and Linerixibat 40 mg in Part B | 0/52 (0%) | 0/52 (0%) | 16/52 (30.8%) |
| Part B: Linerixibat 40 mg in Part A and Placebo in Part B | 0/46 (0%) | 2/46 (4.3%) | 3/46 (6.5%) |
| Part B: Linerixibat 40 mg in Part A and Part B | 0/45 (0%) | 0/45 (0%) | 7/45 (15.6%) |
| Event | Part A: Placebo | Part A: Linerixibat 40 Milligrams (mg) | Part B: Placebo in Part A and Part B | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | Part B: Linerixibat 40 mg in Part A and Placebo in Part B | Part B: Linerixibat 40 mg in Part A and Part B |
|---|---|---|---|---|---|---|
| ThrombocytosisBlood and lymphatic system disorders | 0/118 | 0/119 | 0/53 | 0/52 | 1/46 | 0/45 |
| Renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/118 | 0/119 | 0/53 | 0/52 | 1/46 | 0/45 |
| Sinus arrestCardiac disorders | 1/118 | 0/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| DiverticulitisInfections and infestations | 1/118 | 0/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| Diabetes mellitusMetabolism and nutrition disorders | 1/118 | 0/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| DizzinessNervous system disorders | 1/118 | 0/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| SyncopeNervous system disorders | 1/118 | 0/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| Intermenstrual bleedingReproductive system and breast disorders | 1/118 | 0/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| AnaemiaBlood and lymphatic system disorders | 0/118 | 1/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| Haemorrhagic disorderBlood and lymphatic system disorders | 0/118 | 1/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| Event | Part A: Placebo | Part A: Linerixibat 40 Milligrams (mg) | Part B: Placebo in Part A and Part B | Part B: Placebo in Part A and Linerixibat 40 mg in Part B | Part B: Linerixibat 40 mg in Part A and Placebo in Part B | Part B: Linerixibat 40 mg in Part A and Part B |
|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 21/118 | 72/119 | 3/53 | 14/52 | 0/46 | 6/45 |
| Abdominal painGastrointestinal disorders | 4/118 | 22/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| NauseaGastrointestinal disorders | 11/118 | 12/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| ConstipationGastrointestinal disorders | 11/118 | 9/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| Alanine aminotransferase increasedInvestigations | 4/118 | 11/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| Aspartate aminotransferase increasedInvestigations | 1/118 | 10/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| HeadacheNervous system disorders | 4/118 | 10/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| DyspepsiaGastrointestinal disorders | 1/118 | 9/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| Abdominal distensionGastrointestinal disorders | 6/118 | 8/119 | 0/53 | 0/52 | 0/46 | 0/45 |
| Abdominal pain upperGastrointestinal disorders | 5/118 | 8/119 | 0/53 | 0/52 | 0/46 | 0/45 |
The analysis was performed on Intent-to Treat (ITT) population which included all randomized participants. Participants were classified according to the treatment as randomized.
| Age, Customized(Participants) | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo | Total |
|---|---|---|---|
| 18-49 Years | 42 | 30 | 72 |
| 50-64 Years | 52 | 54 | 106 |
| >=65 Years | 25 | 35 | 60 |
| Sex: Female, Male(Participants) | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo | Total |
|---|---|---|---|
| Female | 113 | 113 | 226 |
| Male | 6 | 6 | 12 |
| Race/Ethnicity, Customized(Participants) | Part A: Linerixibat 40 Milligrams (mg) | Part A: Placebo | Total |
|---|---|---|---|
| HISPANIC OR LATINO | 33 | 21 | 54 |
| NOT HISPANIC OR LATINO | 85 | 95 | 180 |
| UNKNOWN | 1 | 3 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Aug 2021 to primary completion in Oct 2024, 38 months.
Results were first posted in Jul 2025, 8 months after primary completion.
Of 42 industry-sponsored phase 3 interventional studies under Pruritus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 27. This study's 38 months is above that.
Counting every sponsor, half of 48 studies reached it within 19 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Linerixibat