A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)

Launched by IPSEN · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how people with Primary Biliary Cholangitis (PBC), a rare liver disease, experience itching and sleep problems. PBC damages small tubes in the liver, which can lead to liver scarring over time. Many people with PBC suffer from intense itching and trouble sleeping, which can make daily life difficult. This study aims to use a special digital tool, called the ADAM sensor, to measure scratching and sleep patterns more accurately, instead of relying on people’s memories. Each participant will wear this sensor during certain nights over about three months to help gather this important information.

Adults aged 18 and older who have been diagnosed with PBC and are able to use the sensor and complete online surveys may be eligible to join. Participants should not have other skin conditions or movement disorders that could affect the results. If you take part, you’ll be asked to wear the sensor on your body for specific nights and complete electronic questionnaires about your symptoms. This study is not yet recruiting, but it offers a way to better understand the challenges of itching and sleep in PBC, which could help improve care and treatment in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 years or older at time of study enrollment.
• • Confirmed diagnosis of PBC based on medical history and relevant clinical criteria, as determined by the study Investigator.
• • Willingness and ability to wear the ADAM sensor during the specified time periods (7 nights across four 7-day periods).
• • Able to read and write to ensure accurate completion of electronic PRO surveys.
• • Able to access an internet-connected device for the completion of electronic PRO surveys.
• • Able to provide signed, informed consent prior to collection of data.
• Exclusion Criteria:
• • Has already been enrolled in another clinical study.
• • Has any dermatological conditions or severe comorbidities associated with pruritus as assessed by the investigators that may confound the measurement of scratch or sleep data.
• • Has any extrapyramidal syndrome including Parkinsonism, essential tremor, astasia/abasia, cerebellar syndrome.