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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Volixibat 20mg 		Participants randomized to this arm will receive volixibat 20mg twice daily.
  • Drug: Volixibat
    Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
    Other names:
    • SHP626
Experimental
Volixibat 80mg 		Participants randomized to this arm will receive volixibat 80mg twice daily.
  • Drug: Volixibat
    Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
    Other names:
    • SHP626
Placebo Comparator
Placebo 		Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
  • Drug: Placebo
    Capsules matched to study drug without the active pharmaceutical ingredient

Recruiting Locations

MedStar Health Research Institute
Fairfax, Virginia 22031
Contact:
Grace Jin
202-877-6501
joohyun.g.jin@medstar.net

More Details

Status
Recruiting
Sponsor
Mirum Pharmaceuticals, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.