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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|