Last updated: 09/30/2026 12:31:52

J-LINX: Japan LINerixibat eXtension Study

GSK study ID
309859
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Japan Open-Label Linerixibat Safety and Tolerability Extension Study for Cholestatic Pruritus in PBC
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

Timeframe: Up to approximately 18 months (End of study)

Number of Participants With AEs by Severity

Timeframe: Up to approximately 18 months (End of study)

Secondary outcomes:
Not applicable
Interventions:
Drug: Linerixibat
Enrollment:
40
Primary completion date:
2028-23-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pruritus
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2026 to October 2028
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
No
  • 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
  • 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)
Inclusion and exclusion criteria
Inclusion criteria:

    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: o Is a woman of non-childbearing potential (WONCBP), OR o 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 o 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
Exclusion criteria:

    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 location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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