CompletedNot Applicable

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

United States30 participantsStarted 2025-07-16

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Nocturnal Scratch Events

Timeframe: At weeks 0, 4, 8 and 12

Frequency of Low- and High-Intensity Nocturnal Scratch Events

Timeframe: At weeks 0, 4, 8 and 12

Average Scratch Intensity Per Night

Timeframe: At weeks 0, 4, 8 and 12

Hourly Frequency of Nocturnal Scratch Events During Sleep

Timeframe: At weeks 0, 4, 8 and 12

Average Duration of Scratch Events Per Night

Timeframe: At weeks 0, 4, 8 and 12

Total Duration of Scratch Behavior Per Patient During Sleep Periods

Timeframe: At weeks 0, 4, 8 and 12

Total Sleep Duration (Hours)

Timeframe: At weeks 0, 4, 8 and 12

Trial details

NCT IDNCT07049887

SponsorIpsen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-23

View on ClinicalTrials.gov More Primary Biliary Cholangitis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Nocturnal Scratch Events

Timeframe: At weeks 0, 4, 8 and 12

Frequency of Low- and High-Intensity Nocturnal Scratch Events

Timeframe: At weeks 0, 4, 8 and 12

Average Scratch Intensity Per Night

Timeframe: At weeks 0, 4, 8 and 12

Hourly Frequency of Nocturnal Scratch Events During Sleep

Timeframe: At weeks 0, 4, 8 and 12

Average Duration of Scratch Events Per Night

Timeframe: At weeks 0, 4, 8 and 12

Total Duration of Scratch Behavior Per Patient During Sleep Periods

Timeframe: At weeks 0, 4, 8 and 12

Total Sleep Duration (Hours)

Timeframe: At weeks 0, 4, 8 and 12