In short
Clinical trials are investigating Linerixibat in people with cholestatic pruritus linked to primary biliary cholangitis (PBC). These studies mainly look at long-term safety, tolerability, and other trial outcomes in adult participants with cholestasis.
Key points
- Linerixibat is being studied in clinical trials for cholestatic pruritus in primary biliary cholangitis (PBC). The trial data provided describe one Phase 3 interventional study with 292 planned participants. The main goal is to assess long-term safety and tolerability. Researchers are also measuring the frequency and severity of adverse events over time. The study follows participants through many visits across more than a year, with a final follow-up after treatment ends.
Trial overview
The trial data provided describe one interventional study, which means participants receive a treatment so researchers can observe what happens. This study is testing Linerixibat in people with cholestatic pruritus in primary biliary cholangitis (PBC), a long-term liver disease linked with itching. The study is listed as Phase 3 and is authorised.
Who can participate
The available trial includes participants with cholestatic pruritus in PBC. In simple words, this means the study is focused on people who have itching caused by cholestasis, which is reduced or blocked bile flow from the liver. The source data do not give more detailed entry rules, so the exact age limits and other requirements are not provided here.
What researchers are measuring
The main outcome is the frequency and severity of adverse events during treatment and follow-up. Adverse events are any unwanted medical problems that happen during a study, whether or not they are caused by the study treatment. This tells researchers about the long-term safety of Linerixibat and how well participants can tolerate it over time.
The brief study summary says the goal is to evaluate the safety and tolerability of long-term Linerixibat treatment in participants with cholestatic pruritus in PBC. Safety means looking for medical problems, and tolerability means how well people can take the treatment without too many difficulties.
Study design and visits
The study is planned as a long-term trial with many follow-up visits. Assessments are listed at Day 1, Week 1, and then at Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36, 42, and 48, with extra visits if needed. There is also a final follow-up phone call 7 to 14 days after the last dose for people who leave the study early or finish treatment.
The intervention listed is Linerixibat 80 mg taken by mouth. The source data do not provide more details about how the treatment is compared with other study groups, so only the listed intervention can be described here.
Trial status and size
The trial identifier is NCT04124965, and the status is listed as authorised. The planned enrollment is 292 participants, which is the number of people the study aims to include. Because this is a Phase 3 study, it is part of later-stage clinical research with a larger group of participants than early-phase trials.
Only one trial was provided in the source data, so the article focuses on that study. The key research question is whether long-term Linerixibat can be studied safely and with acceptable tolerability in people with cholestatic pruritus in PBC.