Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING 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)

NCT04663308 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 182 participants
Start Date 2020-12-18
Est. Completion 2027-04
Phase Phase 2

Sponsor

Mirum Pharmaceuticals

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04663308

The ClinicalTrials.gov registry entry for NCT04663308 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04663308 reports 20 study locations spanning 10 distinct geographic areas — top geographies include New York, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04663308?

The interventions under investigation include: Placebo (DRUG), Volixibat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04663308?

This trial is sponsored by Mirum Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial