Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial tested a medicine called linerixibat (40 mg) against a placebo (an inactive dummy treatment) in people with a condition that causes itching. The trial ran in two parts: Part A lasted 24 weeks, and Part B ran from week 24 to week 32. In Part A, 119 people were assigned to linerixibat and 119 to placebo. Participants rated their itching and sleep disruption on a scale of 0 to 10 (where 0 means none and 10 means the worst imaginable), and these scores were tracked over time. The reported data shows that, on average over the 24 weeks of Part A, itch scores fell by 2.86 points in the linerixibat group and by 2.15 points in the placebo group (both measured from each person's starting score). For sleep disruption scores, the average reduction over 24 weeks was 2.77 points in the linerixibat group and 2.24 points in the placebo group. At the two-week mark, itch scores had dropped by an average of 1.78 points in the linerixibat group compared to 1.07 points in the placebo group. The reported data also shows that by week 24, 68% of people taking linerixibat and 64% taking placebo had their monthly itch score drop by at least 2 points. When looking at a larger reduction of at least 3 points, 56% of the linerixibat group and 43% of the placebo group met that threshold. For an even larger drop of at least 4 points, the figures were 41% in the linerixibat group and 29% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37953500) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Primary Biliary Cholangitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 80 years old (inclusive) at the time of signing the consent form
- You have been diagnosed with Primary Biliary Cholangitis (PBC), a liver condition (confirm with trial site if unsure about your diagnosis)
- You experience moderate to severe itching related to your condition
Who may not be able to join:
- Your bilirubin levels (a liver marker measured in blood tests) are more than twice the normal upper limit
- Your ALT levels (another liver enzyme measured in blood tests) are significantly above the normal upper limit
- Your kidneys are not filtering blood well enough, based on a specific kidney function measurement (confirm with trial site)
- You have had serious liver complications in the past, such as internal bleeding from swollen veins, confusion caused by liver failure, or fluid build-up in the abdomen
- You currently have hepatitis B, hepatitis C, certain other liver conditions (such as primary sclerosing cholangitis or alcoholic liver disease), or liver/bile duct cancer
- You currently have significant diarrhoea or active inflammation in part of your small intestine, as judged by the doctor
- You currently have painful gallstones or gallbladder inflammation
- You have a primary skin condition where itching is a main feature, such as eczema or psoriasis
- You have a primary sleep disorder such as sleep apnoea, narcolepsy, or excessive sleepiness
- You have started, stopped, or changed the dose of certain liver or itch-related medications (such as UDCA, bezafibrate, or fenofibrate) within the 8 weeks before joining
- You have used a specific medication called obeticholic acid within the 8 weeks before joining, or plan to start it during the study
- You have started, stopped, or changed the dose of certain other itch-related medications (such as antihistamines, rifampicin, naltrexone, gabapentin, or certain antidepressants) within the 8 weeks before joining
- You have taken another drug from the same class as the study treatment (IBAT inhibitors) within the 12 weeks before joining
- You are planning to have any procedures to treat itching caused by liver problems, such as nasobiliary drainage or UV light therapy, at any point during the study
- You have had a previous allergic reaction or intolerance to the study treatment
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Part A: Mean Change From Baseline in Monthly Itch Scores Over 24 Weeks Using Numerical Rating Scale (NRS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.