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Vidofludimus Calcium for Primary Sclerosing Cholangitis

NCT03722576 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-10-17

Study results available
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Summary

To examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period.

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DRUG

Vidofludimus calcium

During the 6-month treatment period, subjects will receive 30 mg VC orally once daily. This will be preceded by a lead-in dosing period where subjects will receive 15 mg VC once daily for 1 week.

Sponsors & Collaborators

  • Arizona State University

    collaborator OTHER

  • Elizabeth Carey

    lead OTHER

Principal Investigators

  • Elizabeth Carey, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03722576 on ClinicalTrials.gov