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NCT05050136 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
A Phase 2 study of Primary Biliary Cholangitis and PBC, sponsored by Mirum Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
- 20
- Study locations
NCT05050136: Recruiting Phase 2 study of Primary Biliary Cholangitis and PBC, sponsored by Mirum Pharmaceuticals.
NCT05050136 is a Phase 2 study of Primary Biliary Cholangitis and PBC that is actively recruiting participants, run by Mirum Pharmaceuticals. The registered enrollment target is 260 participants, above the 174-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05050136, a Phase 2 study of Primary Biliary Cholangitis and PBC, is actively recruiting participants, sponsored by Mirum Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 Outcome
The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Volixibat
Study Locations (20)
Florida
- Covenant Metabolic Specialists - Fort Myers
- UF Hepatology Research at CTRB - Gainesville
- UF Health Gastroenterology- Emerson - Jacksonville
- IHS Health - Kissimmee
- Schiff Center for Liver Diseases - Miami
- Advanced Research Institute, Inc - New Port Richey
- Covenant Research and Clinics, LLC - Sarasota
- Tampa General Hospital - Tampa
- Cleveland Clinic Florida - Weston
California
- Southern California Research Center - Coronado
- Cedars Sinai Medical Center - Los Angeles
- UC Davis - Sacramento
Illinois
- Northwestern University - Chicago
- Loyola University Health System - Loyola Outpatient Center - Maywood
Louisiana
- Ochsner Clinic Foundation-Baton Rouge - Baton Rouge
- LSU Health Science Center Shreveport - Shreveport
Colorado
- University of Colorado - Aurora
Connecticut
- Yale University Digestive Diseases - New Haven
Georgia
- Southeast Clinical Research Center - Dalton
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT05050136 shows while recruiting
NCT05050136 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (49% higher).
The record links to 2 conditions, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05050136 names 20 study sites across 8 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05050136 about?
NCT05050136 is a clinical study titled "A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis". 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.
What is the current status of trial NCT05050136?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2021-09-22. Estimated completion is 2027-07.
What conditions does trial NCT05050136 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis, PBC.
What interventions are being tested in trial NCT05050136?
The interventions under investigation include: Placebo (DRUG), Volixibat (DRUG).
Who is sponsoring clinical trial NCT05050136?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05050136 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Biliary Cholangitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05050136's enrollment target sits among peer trials
260 4th of 8 higher than 5 of 8 other Primary Biliary Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Biliary Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
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