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NCT07860710Not yet recruitingPhase 3

J-LINX: Japan LINerixibat eXtension Study

Japan Open-Label Linerixibat Safety and Tolerability Extension Study for Cholestatic Pruritus in PBC

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
40 (estimated)
First submitted
30 Sept 2026
Start date
9 Oct 2026
Primary completion date
23 Oct 2028
Lead sponsor
GlaxoSmithKline
NCT number
NCT07860710

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 40
  • From 9 Oct 2026 to the primary completion date, 23 Oct 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Presence of hepatic decompensation (e.g., current and unresolved variceal bleeding, encephalopathy, or ascites)
  • Presence of confirmed hepatocellular carcinoma or biliary cancer
  • 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

Lab values

  • Corrected QT Interval (QTc) \>480 milliseconds (msec) at screening (12-lead Electrocardiogram \[ECG\]), subject to rescreening

Other

  • 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
  • Current clinically significant diarrhea in the investigator's medical opinion

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.