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The trial is taking place at:
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Southern California Research Center | Coronado, CA

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

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Mirum Pharmaceuticals

Status and phase

Enrolling
Phase 2

Conditions

PBC
Primary Biliary Cholangitis

Treatments

Drug: Placebo
Drug: Volixibat

Study type

Interventional

Funder types

Industry

Identifiers

NCT05050136
VLX-601

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 3 patient groups, including a placebo group

Volixibat 20mg
Experimental group
Description:
Participants randomized to this arm will receive volixibat 20mg twice daily.
Treatment:
Drug: Volixibat
Volixibat 80mg
Experimental group
Description:
Participants randomized to this arm will receive volixibat 80mg twice daily.
Treatment:
Drug: Volixibat
Placebo
Placebo Comparator group
Description:
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Treatment:
Drug: Placebo

Trial contacts and locations

69

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Data sourced from clinicaltrials.gov

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