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Volixibat for Itching Caused by Primary Biliary Cholangitis

This study is testing an investigational drug called volixibat to see if it can help reduce itching (pruritus) in people with Primary Biliary Cholangitis (PBC). Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor, meaning it works by affecting how bile acids are handled in your body. You might be able to join if you are at least 18 years old and have a confirmed diagnosis of PBC. The main goal is to measure how much your daily itch scores change over 28 weeks while taking volixibat compared to a placebo (an inactive capsule). The study is currently unclear on its recruitment status and plans to enroll about 260 participants.

Study design
This study is testing volixibat against a placebo in about 260 participants. It is an interventional study, meaning participants will receive either the active drug or a placebo.
What's involved
You will need to provide signed informed consent and attend all study visits and requirements through the end of the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at week 28, suggesting follow-up will occur at least until this time point.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05050136

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Mirum Pharmaceuticals, Inc.
~333 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:VolixibatPlacebo

At a glance

Recruiting sites
0 of 130 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire
Measured over Baseline to week 28

Conditions

Primary Biliary Cholangitis
PBC

Explore related trials

Primary Biliary CirrhosisPruritus

Where it's being run

130 sites across 52 states
Italy10
Florida9
Germany9
Israel9
Texas6
France6
Spain6
United Kingdom5

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
Male or female, age ≥18 years at the screening visit
Confirmed diagnosis of PBC in line with the AASLD guidelines
UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria
Qualified pruritus associated with PBC as assessed by Adult ItchRO

Exclusion

Pruritus associated with an etiology other than PBC
Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
Current symptomatic cholelithiasis or inflammatory gallbladder disease
History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded
History of Liver transplantation

What this trial measures

  • Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaireBaseline to week 28

    The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.