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NCT04663308 · 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 Sclerosing Cholangitis (PSC)
A Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Mirum Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 182
- Enrollment target
- 20
- Study locations
NCT04663308: Active Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Mirum Pharmaceuticals.
NCT04663308 is a Phase 2 study of Primary Sclerosing Cholangitis that is active but no longer recruiting, run by Mirum Pharmaceuticals. The registered enrollment target is 182 participants, below the 545-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04663308, a Phase 2 study of Primary Sclerosing Cholangitis, is active but no longer recruiting, sponsored by Mirum Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 182 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 Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
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)
New York
- Northwell Health - Manhasset
- New York University Langone Health - New York
- Weill Cornell Medical College - New York
- Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic - New York
- University of Rochester Medical Center - Strong Memorial Hospital - Rochester
California
- Southern California Research Center - Coronado
- Cedars Sinai Medical Center - Los Angeles
- University of California, Davis - Sacramento
- California Pacific Medical Center Research Institute - San Francisco
Florida
- Florida Research Institute - Lakewood Rch
- University of Miami - Schiff Center for Liver Diseases - Miami
- Tampa General Hospital - Tampa
North Carolina
- Duke Health - Duke University Medical Center - Durham
- Science 37, Inc (Remote-homebased Telemedicine) - Morrisville
Colorado
- University of Colorado - Anschutz Medical Campus - Aurora
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
What the registry record for NCT04663308 still lists
NCT04663308 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 545-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04663308 names 20 study sites across 10 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04663308 about?
NCT04663308 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 Sclerosing Cholangitis (PSC)". 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 Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
What is the current status of trial NCT04663308?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2020-12-18. Estimated completion is 2027-04.
What conditions does trial NCT04663308 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT04663308?
The interventions under investigation include: Placebo (DRUG), Volixibat (DRUG).
Who is sponsoring clinical trial NCT04663308?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04663308 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Sclerosing 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 NCT04663308's enrollment target sits among peer trials
182 6th of 23 higher than 18 of 23 other Primary Sclerosing Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Sclerosing 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
-
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
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-
A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
COMPLETED · Phase 2
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