NCT03722576

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Elizabeth Carey · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-17
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-10-29
• Last updated: 2022-10-17
• Results posted: 2021-06-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study