Last updated: 07/16/2025 18:20:50
Linerixibat Long-term Safety, and Tolerability StudyLLSAT
GSK study ID
212358
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis
Trial description: This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study’s end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)
Timeframe: Up to 66 months
Number of participants with Severe AEs
Timeframe: Up to 66 months
Secondary outcomes:
Change in domain scores of the PBC-40 over time
Timeframe: Baseline and up to 65 months
Change in health-related quality of life (QoL) by the Euro Quality-5 dimension-3 level (EQ-5D-3L) scores over time (Group 1 only)
Timeframe: Baseline and up to 65 months
Change in self-rated health by EQ VAS scores over time (Group 1 only)
Timeframe: Baseline and up to 65 months
Change in the Beck Depression Inventory (BDI-II) scores over time
Timeframe: Baseline and up to 65 months
Number of participants with clinically significant changes in hematology, biochemistry (including lipid and liver parameters), and coagulation parameters
Timeframe: Baseline and up to 65 months
Percentage of responders at Week 24 and Week 52 of continuous treatment (Group 2 only)
Timeframe: Week 24 and Week 52 of continuous treatment
Percentage of participants with maintenance of efficacy at Week 52 of continuous treatment in those that were responders at Week 24 of continuous treatment (Group 2 only)
Timeframe: Week 52 of continuous treatment
Change from Baseline Monthly Sleep Score (MSS) (Group 2 only)
Timeframe: Baseline and up to Week 52 of continuous treatment
Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only)
Timeframe: Baseline and up to Week 52 of continuous treatment
Interventions:
Enrollment:
245
Primary completion date:
2027-31-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cholestasis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2020 to August 2027
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
No
- Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant’s parent trial BAT117213, GLIMMER or GLISTEN.
- Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
- Screening total bilirubin >2x upper limit of normal (ULN).
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >6x ULN.
Inclusion and exclusion criteria
Inclusion criteria:
- Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant’s parent trial BAT117213, GLIMMER or GLISTEN.
- Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
- Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is a woman of non-childbearing potential (WONCBP) or b) is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method.
- Capable of giving signed informed consent.
Exclusion criteria:
- Screening total bilirubin >2x upper limit of normal (ULN).
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >6x ULN.
- Screening estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
- Presence of actively replicating viral hepatitis B or C (Viral Hepatitis B [HBV], viral Hepatitis C [HCV]) infection), primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
- Current clinically significant diarrhea in the Investigator’s medical opinion.
- Current symptomatic cholelithiasis or cholecystitis.
- Current diagnosis or previous diagnosis of colorectal cancer.
- Any current malignancies (including hematologic and solid malignancies).
- History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years.
- Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or early study withdrawal.
- Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening until after the end of the study or early study withdrawal.
- QT interval corrected (QTc) >480 millisecond (msec) at screening (12-lead ECG)
- Participants with moderate (or greater) alcohol consumption defined as more than one standard drink per day for women and two drinks per day for men.
Trial location(s)
Location
GSK Investigational Site
Detroit, MI, United States, 48377
Status
Recruitment Complete
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Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
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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