Loading clinical trials...

Vidofludimus Calcium for Primary Sclerosing Cholangitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Vidofludimus Calcium for Primary Sclerosing Cholangitis

Investigation of the Activity of Vidofludimus Calcium, a Novel, Orally Available, Small Molecule Inhibitor of Dihydroorotate Dehydrogenase, as a Treatment for Primary Sclerosing Cholangitis (PSC)

NCT03722576•Elizabeth Carey

View on ClinicalTrials.gov

Summary

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

Detailed Description

Investigators will assess the following: 1. Changes on serum alkaline phosphatase levels at 3 \& 6 months. 2. Changes in other liver biochemistries at 3 \& 6 months. 3. Changes in IL-17 \&IFNγ levels at 6 weeks and 6 months.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female subject age 18-75 years
•2. Diagnosis of PSC consistent with the guidelines published by the AASLD. All subjects must have an elevated serum ALP of at least 1.5 times upper limit of normal (ULN) at baseline plus cholangiographic evidence of PSC (MRI, endoscopic retrograde cholangiography, or direct cholangiography).
•3. Indirect bilirubin \<1.2 times the ULN
•4. An ultrasound (or equivalent imaging modality) that excludes biliary obstruction and malignancy within 6 months of study enrollment
•5. PSC with or without inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
•6. Must agree to comply with the study protocol and provide informed consent

Exclusion Criteria

•1. Pregnancy, attempting to become pregnant, or breastfeeding
•2. Active hepatitis A or B infection
•3. Active hepatitis C infection (antibody positive); patients with a history of hepatitis C infection will be eligible for this study if they have undetectable levels of HCV RNA
•4. HIV/AIDS (per medical record or HIVAb/HIA antigen), tuberculosis, or positive interferon-gamma assay (IGRAs) for Mycobacterium tuberculosis
•5. Other cholestatic liver disease such as primary biliary cholangitis and cholestatic diseases of pregnancy
•6. Metabolic liver diseases such as Wilson's disease, Gilbert's syndrome or hemochromatosis
•7. Serum uric acid levels at screening \>1.2 ULN
•8. Inherited diseases of the liver such as α-1 antitrypsin deficiency
•9. Immunoglobulin G4-related cholangitis
•10. PSC with concomitant autoimmune hepatitis (AIH) and/or primary biliary cholangitis
+15 more criteria

Locations (3)

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Arizona State University

Tempe, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

June 17, 2019

Primary Completion Date

June 30, 2020

Completion Date

June 30, 2020

Last Updated

October 17, 2022

Enrollment

ACTUAL participants

Conditions

Primary Sclerosing Cholangitis

Interventions

Vidofludimus calcium

DRUG

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

NCT04753996

Primary Sclerosing CholangitisPSC+1 more

View study

RECRUITING

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

NCT05750498

Autoimmune HepatitisPrimary Sclerosing Cholangitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vidofludimus Calcium for Primary Sclerosing Cholangitis

Inclusion Criteria

Exclusion Criteria

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Liver Cirrhosis Network Cohort Study

S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)