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

Completed

Conditions studied: Primary Biliary Cholangitis

In brief

This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). People living with PBC often face challenges like intense itching, trouble sleeping, and feeling constantly tired. These symptoms can make it hard for them to enjoy daily life and feel well overall. While itching and sleep patterns can be difficult to measure accurately based on recall and may lack precision, the main aim of this study is to use a digital health tool to assess the severity of itchiness and sleep patterns in people with PBC. The tool will take the objective measurement for people so they do not have to recall their scratch and sleep patterns. The total study duration for each patient will be about 91 days.

Key facts

Study ID

NCT07049887

Run by

Ipsen

People needed

30

Starts

2025-07-16

Expected to finish

2026-02-23

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Liver Center — Chandler, Arizona, United States
• University of Miami School of Medicine, Center for Liver Diseases — Miami, Florida, United States
• UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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