Vidofludimus Calcium for Primary Sclerosing Cholangitis (PSC)
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|ClinicalTrials.gov Identifier: NCT03722576|
Recruitment Status : Not yet recruiting
First Posted : October 29, 2018
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Sclerosing Cholangitis||Drug: Vidofludimus calcium||Phase 2|
Investigators will assess the following:
- Changes on serum alkaline phosphatase levels at 3 & 6 months.
- Changes in other liver biochemistries at 3 & 6 months.
- Changes in IL-17 &IFNγ levels at 6 weeks and 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Vidofludimus Calcium
Drug: Vidofludimus calcium
30 mg VC orally once daily
Other Name: IMU-838
- Changes on serum alkaline phosphatase levels at 3 and 6 months [ Time Frame: 3 - 6 months ]Determine if VC reduces serum alkaline phosphatase (ALP) in adults with PSC by comparing changes in levels of serum ALP after 3 and 6 months of VC treatment baseline levels (month 0).
- Changes in other liver biochemistries levels at 3 and 6 months [ Time Frame: 3 - 6 months ]Compare other liver biochemistries at 3 and 6 months of VC treatment to baseline. Other biochemistries include: bilirubin, total & direct aspartate and alanine transaminases (AST & ALT).
- Changes in IL-17 and IFNγ levels at 6 weeks and months [ Time Frame: 6 weeks - 6 months ]Assess proinflammatory cytokine profile (IL-17 and IFNγ) at baseline, 6 weeks and 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722576
|Contact: Travis Johnson, CCRP||408-342-2942||Johnson.Travis2@mayo.edu|
|United States, Arizona|
|Mayo Clinic in Arizona||Not yet recruiting|
|Phoenix, Arizona, United States, 85259|
|Contact: Elizabeth Carey, MD 480-342-1094|
|Arizona State University||Active, not recruiting|
|Tempe, Arizona, United States, 85281|
|United States, Minnesota|
|Mayo Clinic in Rochester||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: John Eaton, MD 507-284-3987|
|Principal Investigator:||Elizabeth Carey, MD||Mayo Clinic|