A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

To join this study, you need to be at least 18 years old and have a clear diagnosis of Primary Biliary Cholangitis (PBC). A key part of qualifying is that you must be experiencing itching due to your PBC, and this will be checked using a special questionnaire.

You might still be able to join if you are already taking certain other medications for PBC or itching, such as UDCA or anti-itch medicines, as long as you meet additional requirements. Importantly, your liver condition should be stable, and you shouldn't have signs of severe liver damage or certain other liver diseases.

However, you won't be able to participate if your itching is caused by something other than PBC, or if you have severe or unstable liver disease. Also, if you've had major surgery on your small bowel or a liver transplant, or if you have certain gallbladder problems, you wouldn't be able to take part in this particular study.

If you decide to take part, you'll first have a screening visit to check if the study is right for you. If you qualify, you'll be given either the study medicine, Volixibat, or a placebo (a look-alike medicine with no active drug). You or your doctor won't know which one you're receiving. You will need to attend several clinic visits over a period to monitor your health, how your itching is, and how you are responding to the treatment. These visits will involve health checks, possibly blood tests, and questionnaires about your symptoms. The doctors and nurses will explain all the procedures in detail. You'll be closely monitored for any side effects or changes to your health throughout the study. The total duration of your participation, including all visits and follow-ups, will be clearly explained to you before you agree to join.