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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis - VANTAGE

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041240104

Enrollment

Registered

2024-10-09

Start date

2025-02-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestatic Pruritus in Patients with Primary Biliary Cholangitis

Interventions

Volixibat (20 mg or 80 mg) or placebo is administered orally twice daily.

Eligibility

Sex/Gender

All

Inclusion 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 and anti-pruritic medication use will be allowed if meeting additional criteria - Qualified pruritus associated with PBC as assessed by Adult ItchRO

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire	—

Secondary

Measure	Time frame
- Proportion of participants with itch response using the Adult ItchRO - Incidence of adverse events - Changes in alkaline phosphatase - Changes in total bilirubin - Changes in serum bile acid levels - Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40) - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue questionnaire - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance questionnaire	—

Measure

Time frame

- Proportion of participants with itch response using the Adult ItchRO - Incidence of adverse events - Changes in alkaline phosphatase - Changes in total bilirubin - Changes in serum bile acid levels - Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40) - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue questionnaire - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance questionnaire

—

Countries

Argentina, Belgium, Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, UK, US

Contacts

Public ContactAtsuko Sugimoto

Syneos Health Japan K.K.

VLX-601@syneoshealth.com+81-80-3028-8939

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026