PruritusPhase 3NCT07860710
J-LINX: Japan LINerixibat eXtension Study
A Phase 3 study testing Linerixibat in people with Pruritus, run by GlaxoSmithKline.
Trial summary
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and efficacy study, LLSAT (NCT04167358). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pruritus
- What is being tested?
- Linerixibat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2026to 23 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into an eligible linerixibat clinical study prior to LLSAT (GLIMMER or GLISTEN)
- Participants must have completed the main treatment period in LLSAT
- A Female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following applies:
- Is a woman of non-childbearing potential (WONCBP), OR
- Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the study intervention period (at a minimum until 4 weeks after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention, etc.)
- WOCBP must have a negative highly sensitive urine pregnancy test (or serum, as required by local regulations) within 7 days before the baseline visit
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
- Capable of giving signed informed consent
Who cannot join
- Participants who met LLSAT protocol-defined Liver Monitoring or Liver Stopping criteria and who remain off study treatment or where Liver Event is not resolved at the Final Visit in LLSAT
- Presence of hepatic decompensation (e.g., current and unresolved variceal bleeding, encephalopathy, or ascites)
- Presence of confirmed hepatocellular carcinoma or biliary cancer
- Current clinically significant diarrhea in the investigator's medical opinion
- Any current medical condition (e.g., psychiatric disorder, senility, or dementia) which, in the investigator's opinion, may affect the participant's ability to comply with protocol-specified procedures
- Current enrollment or participation in any other clinical study (except for LLSAT) involving an investigational study treatment within 8 weeks prior to the Screening Visit
- Corrected QT Interval (QTc) >480 milliseconds (msec) at screening (12-lead Electrocardiogram [ECG]), subject to rescreening
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Japan Open-Label Linerixibat Safety and Tolerability Extension Study for Cholestatic Pruritus in PBC
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and efficacy study, LLSAT (NCT04167358). Participants will continue receiving linerixibat while researchers monitor adverse events and other safety measures to better understand the long-term safety of treatment and provide continued access to therapy.
- Conditions
- Pruritus
- Being tested
- Linerixibat
- Keywords
- Primary Biliary Cholangitis (PBC), Cholestatic Pruritus, Linerixibat, Pruritus, Autoimmune Liver Disease
- Medical subject headings
- Pruritus, Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinerixibatDrug
Linerixibat will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Linerixibat | Experimental | Participants with cholestatic pruritus associated with primary biliary cholangitis (PBC) who completed the LLSAT study will receive linerixibat. Receives: Drug: Linerixibat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Measured: Up to approximately 18 months (End of study)
Number of Participants With AEs by Severity
Measured: Up to approximately 18 months (End of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start9 Oct 2026 (estimated)
- Primary completion23 Oct 2028 (estimated)
- Study completion23 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860710
- Sponsor's protocol ID
- 309859
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japan Open-Label Linerixibat Safety and Tolerability Extension Study for Cholestatic Pruritus in PBC
- ClinicalTrials.gov ID
- NCT07860710
- Acronym / sponsor ID
- 309859
- Conditions
- Pruritus
- Keywords
- Primary Biliary Cholangitis (PBC), Cholestatic Pruritus, Linerixibat, Pruritus, Autoimmune Liver Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2026 (estimated)
- Primary completion
- 23 Oct 2028 (estimated)
- Study completion
- 23 Oct 2028 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and efficacy study, LLSAT (NCT04167358). Participants will continue receiving linerixibat while researchers monitor adverse events and other safety measures to better understand the long-term safety of treatment and provide continued access to therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linerixibat | Experimental | Drug: LinerixibatParticipants with cholestatic pruritus associated with primary biliary cholangitis (PBC) who completed the LLSAT study will receive linerixibat. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into an eligible linerixibat clinical study prior to LLSAT (GLIMMER or GLISTEN)
- Participants must have completed the main treatment period in LLSAT
- A Female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following applies:
- WOCBP must have a negative highly sensitive urine pregnancy test (or serum, as required by local regulations) within 7 days before the baseline visit
- Capable of giving signed informed consent
Key exclusion criteria (7 listed)
- Participants who met LLSAT protocol-defined Liver Monitoring or Liver Stopping criteria and who remain off study treatment or where Liver Event is not resolved at the Final Visit in LLSAT
- Presence of hepatic decompensation (e.g., current and unresolved variceal bleeding, encephalopathy, or ascites)
- Presence of confirmed hepatocellular carcinoma or biliary cancer
- Current clinically significant diarrhea in the investigator's medical opinion
- Any current medical condition (e.g., psychiatric disorder, senility, or dementia) which, in the investigator's opinion, may affect the participant's ability to comply with protocol-specified procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinerixibatLinerixibat will be administered. | Drug | Linerixibat |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Up to approximately 18 months (End of study)
Number of Participants With AEs by Severity
Time frame: Up to approximately 18 months (End of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Related trials for Pruritus
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
Not yet recruitingEarly Phase 1
Topical Minocycline for CARP
Confluent and Reticulated Papillomatosis (CARP)
Active, not recruiting
Pain Sensitivity and Pruritus of Peripheral Nerves
ITCH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Linerixibat in people with Pruritus, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (time frame: Up to approximately 18 months (End of study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.