Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
ACTIVE NOT RECRUITINGPhase2

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

Sponsor: Mirum Pharmaceuticals, Inc.

NCT ID: NCT05050136

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
Mix of remote tasks and in-person visits
Drug or intervention
Volixibat (drug), Placebo (drug)
How long the study runs
Study runs about 87 months (dates as stated)
About the drug or intervention
Volixibat — drug: Oral capsules, administered twice daily. · Placebo — drug: Capsules matched to study drug without the active pharmaceutical ingredient
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
333
Started
2021-09-22
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for primary biliary cholangitis
  • • Phase2 - 333 participants
  • • The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with primary biliary cholangitis

Where?

  • • Southampton - University Hospital Southampton NHS Foundation Trust
  • • Birmingham - University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters
  • • Belfast - Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital
  • • London - Royal Free Hospital NHS Foundation Trust
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

Primary Biliary CholangitisPBC

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Provide signed agreement to take part at the screening visit as well as comply with all study visits and requirements...
  • ✓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

Who cannot take part

  • ✗Pruritus associated with an etiology other than PBC
  • ✗Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
  • ✗Current causing symptoms 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
See the full criteria
Inclusion Criteria: * 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 Criteria: * 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

Where Is This Study? (7 UK sites)

University Hospital Southampton NHS Foundation Trust

Southampton S016 6YD, United Kingdom

Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters

Birmingham B15 2GW, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital

Belfast BT12 6BA, United Kingdom

Hospital R&D contact (matched)

Alison Murphy

alison.murphy@belfasttrust.hscni.net028 9063 6366

Royal Free Hospital NHS Foundation Trust

London NW3 2QZ, United Kingdom

Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

King's College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924
Data sourced from ClinicalTrials.gov · Last verified: 2026-08