This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
Secukinumab 300 mg was provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab consisted of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 48 inclusive. The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occurred on days of study visits. The injections not occurring on days of study visits were done by the patients (or caregivers) at home.
Placebo was provided in 1 mL prefilled syringe. Each placebo dose consisted of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3, 4), then after four weeks at Week 8. At Week 12, patients were switched to receive 300 mg secukinumab once weekly for five weeks (Weeks 12, 13, 14, 15, 16) followed by monthly dosing through Week 48 inclusive. The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occured on days of study visits. The injections not occurring on days of study visits were done by the patients (or caregivers) at home.
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Santa Ana, California, United States
Novartis Investigative Site
Rockville, Maryland, United States
Aortic Vascular Inflammation as Measured by FDG-PET/CT
Change from baseline in the target to background ratio from the whole aorta. Effect of secukinumab 300 mg subcutaneous (sc) compared to placebo on aortic vascular inflammation with respect to the change from baseline in the target (arterial vascular uptake) to background (venous blood pool) ratio from the aorta. The primary analysis time point was at Week 12. Increased aortic vascular inflammation as measured by (18F) fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT)
Time frame: baseline, 12 weeks
Change in Adiponectin Total
Change from baseline in Adiponectin to measure adiposity
Time frame: baseline, 12 weeks
Change in Apolipoprotein B
Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes
Time frame: baseline, 12 weeks
Change in CRP
Change from baseline in C reactive protein (CRP), a measure of inflammation
Time frame: baseline, 12 weeks
Change in Cholesterol
Change from baseline in Cholesterol level
Time frame: baseline, 12 weeks
Change in Fetuin A
Change from baseline in Fetuin A, a marker predictive of diabetes
Time frame: baseline, 12 weeks
Change in Ferritin
Change from baseline in Ferritin, a marker predictive of diabetes
Time frame: baseline, 12 weeks
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Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Buffalo, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Exton, Pennsylvania, United States
Novartis Investigative Site
Dallas, Texas, United States
...and 2 more locations
Change in GlycA
Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation
Time frame: baseline, 12 weeks
Change in HDL Cholesterol
Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker
Time frame: baseline, 12 weeks
Change in HDL Function (Cholesterol Efflux)
Change from baseline in High Density Lipoprotein (HDL) Cholesterol (cholesterol efflux) , a cardiometabolic biomarker Ratio of the pleated serum to removal of Cholesterol
Time frame: baseline, 12 weeks
HDL Particle Total
Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total
Time frame: baseline, 12 weeks
HDL Size
Change from baseline in High Density Lipoprotein (HDL) Cholesterol size
Time frame: baseline, 12 weeks
HOMA-IR
Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin \[uIU/mL (mU/L)\] x Glucose (mg/dL) = HOMA-IR
Time frame: baseline, 12 weeks
Change in IL-2 Receptor A
Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes
Time frame: baseline, 12 weeks
Change in IL-18
Interleukin-18 (IL-18) is a marker predictive of diabetes
Time frame: baseline, 12 weeks
Change in IL-6
Interleukin 6 (IL-6) is a marker of inflammation
Time frame: baseline, 12 weeks
Change in Intermediate-Density Lipoprotein (IDL) Particle
Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function
Time frame: baseline, 12 weeks
Change LDL Cholesterol
Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function
Time frame: baseline, 12 weeks
Change in Leptin
Change from baseline in Leptin a marker of adiposity
Time frame: baseline, 12 weeks
LDL Particle Total
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total
Time frame: baseline, 12 weeks
LDL Size
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size
Time frame: baseline, 12 weeks
Change in Triglycerides
Triglycerides are a marker of cardiometabolic function
Time frame: baseline, 12 weeks
Change in TNF-α
Change in Tumor necrosis factor (TNF, tumor necrosis factor alpha, TNFα is a marker of inflammation Also written as TNF-alpha
Time frame: baseline, 12 weeks
Change VLDL Particle Total
Change in Very-low-density lipoprotein (VLDL) cholesterol level
Time frame: baseline, 12 weeks
VLDL Size
Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size
Time frame: baseline, 12 weeks
Area and Severity Index 75 (PASI 75)
Percentage of participants with PASI75 response (yes, no) PASI75 response = at least a 75% improvement (reduction) in PASI score compared to baseline Psoriasis Area and Severity Index ( PASI) is a tool for measuring the severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Time frame: week 12
Psoriasis Area and Severity Index 90 (PASI 90)
Percentage of participants with PASI90 response (yes, no) PASI90 response = at least a 90\& improvement (reduction) in PASI score compared to baseline
Time frame: week 12
Psoriasis Area and Severity Index 100 (PASI100)
Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis
Time frame: week 12
Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1
percentage of participants with IGA mod 2011 score of 0 or 1 (yes, no) Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 Statistical analysis (Cochran-Mantel-Haenszel test) of Novartis Investigator's Global Assessment Modified 2011 0 or 1 response by visit (Non-responder Imputation)
Time frame: week 12
Dermatology Life Quality Index (DLQI) Total Score
Change from baseline in the DLQI total score Summary of analysis of change from baseline in DLQI at Week 12 and statistical analysis (using Analysis of Covariance) of change from baseline in DLQI at Week 12 The higher the score, the more quality of life is impaired. 0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life
Time frame: baseline, 12 weeks