Trial Outcomes & Findings for MIcrovascular dysfuNction In Moderate-severe Psoriasis (NCT NCT04271540)
NCT ID: NCT04271540
Last Updated: 2025-11-25
Results Overview
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.
COMPLETED
PHASE4
36 participants
24 weeks
2025-11-25
Participant Flow
Participant milestones
| Measure |
Subjects treated with Tildrakizumab
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.
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|---|---|
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Overall Study
STARTED
|
36
|
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Overall Study
COMPLETED
|
30
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Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Subjects treated with Tildrakizumab
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.
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|---|---|
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Overall Study
Lost to Follow-up
|
1
|
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Overall Study
Screen Fail
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5
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Baseline Characteristics
MIcrovascular dysfuNction In Moderate-severe Psoriasis
Baseline characteristics by cohort
| Measure |
Subjects Treated With Tildrakizumab
n=31 Participants
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.
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|---|---|
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Age, Continuous
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61 years
STANDARD_DEVIATION 11.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
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Psoriasis Area and Severity Index (PASI)
|
10.9 scores on a scale
n=9 Participants
|
|
Physician's Global Assessment of Psoriasis (PGAP)
|
3.0 scores on a scale
n=9 Participants
|
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Number of Participants with Psoriatic Arthritis
|
10 Participants
n=9 Participants
|
|
Number of Participants with Coronary Artery Disease (CAD)
|
5 Participants
n=9 Participants
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Number of Participants with Hypertension
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17 Participants
n=9 Participants
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Number of Participants with Diabetes mellitus
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5 Participants
n=9 Participants
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|
Number of Participants with Obesity
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18 Participants
n=9 Participants
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Number of Participants with Dyslipidemia
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24 Participants
n=9 Participants
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Number of Participants with On Statin
|
10 Participants
n=9 Participants
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|
Atherosclerotic Coronary Artery Disease (ASCVD) Risk Score
|
7 Percentage
n=9 Participants
|
|
High-sensitivity Troponin T (Hs-TnT)
|
10 mg/L
n=9 Participants
|
|
High-Sensitivity C-Reactive Protein (hs-CRP)
|
2.6 mg/L
n=9 Participants
|
|
N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
|
57 pg/mL
n=9 Participants
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Lipid panel
Total cholesterol
|
191 mg/dl
n=9 Participants
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|
Lipid panel
LDL
|
103 mg/dl
n=9 Participants
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|
Lipid panel
HDL
|
50 mg/dl
n=9 Participants
|
|
Lipid panel
Triglycerides
|
140 mg/dl
n=9 Participants
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Coronary Flow Reserve (CFR)
|
2.63 Ratio
STANDARD_DEVIATION .72 • n=9 Participants
|
|
Myocardial Blood Flow (MBF)
Global Rest MBF
|
0.81 ml/min/g
STANDARD_DEVIATION .15 • n=9 Participants
|
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Myocardial Blood Flow (MBF)
Global Stress MBF
|
2.06 ml/min/g
STANDARD_DEVIATION .42 • n=9 Participants
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CFR <2.5
|
15 Participants
n=9 Participants
|
|
Heart rate (HR)
Resting HR
|
74 bpm
STANDARD_DEVIATION 31 • n=9 Participants
|
|
Heart rate (HR)
Peak HR
|
95.2 bpm
STANDARD_DEVIATION 27 • n=9 Participants
|
PRIMARY outcome
Timeframe: 24 weeksChange (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.
Outcome measures
| Measure |
Subjects treated with Tildrakizumab
n=30 Participants
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.
|
|---|---|
|
Change in Global Coronary Flow Reserve (CFR) After 6 Months of Therapy With Tildrakizumab
|
-0.03 CFR Ratio
Standard Deviation 0.83
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SECONDARY outcome
Timeframe: 24 weeksCorrelation 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
Outcome measures
| Measure |
Subjects treated with Tildrakizumab
n=31 Participants
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.
|
|---|---|
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Correlation Between Change in Global CFR and Psoriasis Skin Severity
|
0.18 Spearman's rank correlation coefficient
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SECONDARY outcome
Timeframe: 24 weeksChange (from baseline) in peak-stress global myocardial blood flow (in mL/min/g) at 24 weeks after initiation of Tildrakizumab
Outcome measures
| Measure |
Subjects treated with Tildrakizumab
n=30 Participants
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.
|
|---|---|
|
Change in Peak-stress Global Myocardial Blood Flow
|
0.07 ml/min/g
Standard Deviation 0.41
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SECONDARY outcome
Timeframe: 24 weeksChange (from baseline) in peak-stress global coronary vascular resistance (in mm Hg/mL/min/g) at 24 weeks after initiation of Tildrakizumab
Outcome measures
| Measure |
Subjects treated with Tildrakizumab
n=30 Participants
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.
|
|---|---|
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Change in Peak-stress Global Coronary Vascular Resistance
|
-1.1 mm Hg/mL/min/g
Standard Deviation 13.15
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Adverse Events
Subjects treated with Tildrakizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects treated with Tildrakizumab
n=31 participants at risk
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.
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|---|---|
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Infections and infestations
COVID infection
|
9.7%
3/31 • from enrollment until one week after completion of the trial, an average of 27 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place