A Phase 4 interventional study of Tildrakizumab in Psoriasis and Cardiovascular Disease, sponsored by Marcelo F. Di Carli, MD, FACC. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Marcelo F. Di Carli, MD, FACC · Phase 4, Interventional, and Treatment
Psoriasis, a common chronic inflammatory skin disease affecting approximately 2% of the population, is associated with increased cardiovascular (CV) risk. Despite the implication of inflammation in this excess risk, it remains unclear whether reducing inflammation reduces the risk of cardiac events. This study proposes to test whether Tildrakizumab, an FDA approved therapy for psoriasis that blocks IL-23 and the Th17 pathway of inflammation, improves coronary vascular function and coronary flow reserve, as measured by noninvasive imaging with cardiac positron emission tomography. In so doing, improvement in coronary vasoreactivity, endothelial function, and tissue perfusion may have beneficial effects on myocardial mechanics, left ventricular deformation and function and, ultimately, symptoms and prognosis.
This research may offer novel insights into the contributors of CV risk in psoriasis and provide data to support the development of strategies to prevent cardiovascular events in psoriatic disease.
The primary objective of this study is to investigate the impact of Tildrakizumab therapy on coronary vasoreactivity and myocardial mechanics, as indicators of subclinical cardiovascular disease in patients with psoriatic disease and intermediate-high CV risk. Impaired coronary flow reserve (CFR) is a measure of coronary vasoreactivity and a manifestation of myocardial ischemia which may precede clinical CV events (and visible changes in plaque morphology) in high-risk patients with psoriatic disease. From previous studies, it is known that traditional risk factors underestimate cardiovascular risk in psoriatic disease. Tildrakizumab, a p19 inhibitor which blocks IL-23 and Th17 mediated inflammation, is an FDA approved therapy for moderate-severe psoriasis and has been shown to reduce inflammation. Furthermore, IL-17 is associated with endothelial dysfunction and atherosclerosis. The central hypothesis is that reducing systemic inflammation using tildrakizumab will quantitatively improve myocardial blood flow and CFR as measured by PET over 6 months; and this improvement in coronary vasoreactivity, endothelial function, and tissue perfusion may have beneficial effects on myocardial mechanics, left ventricular function and, ultimately, symptoms and prognosis.
This is a single-arm open-label mechanistic clinical study in adult subjects with moderate-severe psoriasis and increased cardiovascular risk. We plan to enroll approximately 35 patients to receive Tildrakizumab over 6 months. The study will consist of 4-5 visits including a virtual or in person screening visit, a baseline visit in which baseline imaging tests will be conducted and study drug will be dispensed, two in person visits for which study drug will be given and monitoring of AE events and compliance, and a final visit in visit in which imaging tests will be repeated
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 36 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Marcelo F. Di Carli, MD, FACC is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
In order for an individual to participate, they must meet all of the inclusion and exclusion criteria as outlined below.
Inclusion Criteria include the following:
Evidence of at least one cardiovascular risk factor which includes hsCRP ≥ 2 mg/L, DM, obesity (BMI>25), hyperlipidemia, hypertension, family history of early coronary artery disease, or evidence of metabolic syndrome
---Metabolic syndrome defined as at least three of the following: glucose>100mg/dl or taking hypoglycemic agent, HDL\<40mg/dl (men) or 50 mg/dl (women), triglycerides ≥150mg/dl, waist circumference >40 in mean or >35 in women, or blood pressure ≥130/85 or taking anti-hypertensive.
Exclusion Criteria include the following:
Informed consent will be obtained from study participants willing to participate in MiNIMA. Study participants will then undergo the baseline rest/stress cardiac PET scan. The final PET scan will occur at 6 months after the intervention.
Drug: Tildrakizumab
Tildrakizumab, a p19 inhibitor which blocks IL-23 and Th17 mediated inflammation, will be given for 6 months. As below, a baseline cardiac PET scan will be performed prior to initiation and after 6 months of treatment. Radiation: A cardiac PET scan will be performed at baseline and at 6 months
Also known as: Ilumya
Change in Global Coronary Flow Reserve (CFR) After 6 Months of Therapy With Tildrakizumab
Change (from baseline) in global CFR, as measured by PET imaging at 24 weeks after initiation of Tildrakizumab therapy. Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired MBFR is defined as a ratio of \<2.0, which is associated with increased cardiovascular risk.
Time frame: 24 weeks
Correlation Between Change in Global CFR and Psoriasis Skin Severity
Correlation between the change (from baseline) in global CFR and psoriasis skin severity scores (Body surface area \[BSA\], Physician's Global Assessment \[PGA\], Psoriasis Area and Severity Index \[PASI\]) at 24 weeks after initiation of Tildrakizumab
Time frame: 24 weeks
Change in Peak-stress Global Myocardial Blood Flow
Change (from baseline) in peak-stress global myocardial blood flow (in mL/min/g) at 24 weeks after initiation of Tildrakizumab
Time frame: 24 weeks
Change in Peak-stress Global Coronary Vascular Resistance
Change (from baseline) in peak-stress global coronary vascular resistance (in mm Hg/mL/min/g) at 24 weeks after initiation of Tildrakizumab
Time frame: 24 weeks
| Milestone | Subjects treated with Tildrakizumab |
|---|---|
| Started | 36 |
| Completed | 30 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Screen fail | 5 |
Change (from baseline) in global CFR, as measured by PET imaging at 24 weeks after initiation of Tildrakizumab therapy. Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired MBFR is defined as a ratio of \<2.0, which is associated with increased cardiovascular risk.
| CFR Ratio | Subjects treated with Tildrakizumab |
|---|---|
| Change in Global Coronary Flow Reserve (CFR) After 6 Months of Therapy With Tildrakizumab | -0.03 ± 0.83 |
Correlation between the change (from baseline) in global CFR and psoriasis skin severity scores (Body surface area \[BSA\], Physician's Global Assessment \[PGA\], Psoriasis Area and Severity Index \[PASI\]) at 24 weeks after initiation of Tildrakizumab
| Spearman's rank correlation coefficient | Subjects treated with Tildrakizumab |
|---|---|
| Correlation Between Change in Global CFR and Psoriasis Skin Severity | 0.18 |
Change (from baseline) in peak-stress global myocardial blood flow (in mL/min/g) at 24 weeks after initiation of Tildrakizumab
| ml/min/g | Subjects treated with Tildrakizumab |
|---|---|
| Change in Peak-stress Global Myocardial Blood Flow | 0.07 ± 0.41 |
Change (from baseline) in peak-stress global coronary vascular resistance (in mm Hg/mL/min/g) at 24 weeks after initiation of Tildrakizumab
| mm Hg/mL/min/g | Subjects treated with Tildrakizumab |
|---|---|
| Change in Peak-stress Global Coronary Vascular Resistance | -1.1 ± 13.15 |
Collected over from enrollment until one week after completion of the trial, an average of 27 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects treated with Tildrakizumab | 0/31 (0%) | 0/31 (0%) | 3/31 (9.7%) |
| Event | Subjects treated with Tildrakizumab |
|---|---|
| COVID infectionInfections and infestations | 3/31 |
| Age, Continuous(years) | Subjects Treated With Tildrakizumab |
|---|---|
| Mean | 61 ± 11.3 |
| Sex: Female, Male(Participants) | Subjects Treated With Tildrakizumab |
|---|---|
| Female | 12 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | Subjects Treated With Tildrakizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 0 |
| White | 27 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Subjects Treated With Tildrakizumab |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
| Psoriasis Area and Severity Index (PASI)(scores on a scale) | Subjects Treated With Tildrakizumab |
|---|---|
| Median | 10.9 (6.7 to 15.6) |
| Physician's Global Assessment of Psoriasis (PGAP)(scores on a scale) | Subjects Treated With Tildrakizumab |
|---|---|
| Median | 3.0 (2 to 3) |
| Number of Participants with Psoriatic Arthritis(Participants) | Subjects Treated With Tildrakizumab |
|---|---|
| Count of participants | 10 |
| Number of Participants with Coronary Artery Disease (CAD)(Participants) | Subjects Treated With Tildrakizumab |
|---|---|
| Count of participants | 5 |
14 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Marcelo F. Di Carli, MD, FACC