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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02690701
Other study ID # CAIN457AUS02
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 10, 2016
Est. completion date February 19, 2018

Study information

Verified date July 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date February 19, 2018
Est. primary completion date April 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males and females at least 18 years of age with moderate to severe plaque psoriasis Exclusion Criteria: - Forms of psoriasis other than chronic plaque psoriasis - Previous exposure to IL-17A or IL-17 receptor targeting agents. - Other active or ongoing disease that may interfere with evaluation of psoriasis or places the patient at unacceptable risk - Other protocol-defined inclusion/exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Secukinumab 300 mg
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.
Biological:
Placebo
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.

Locations

Country Name City State
United States Novartis Investigative Site Buffalo New York
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Exton Pennsylvania
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Los Angeles California
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 Rockville Maryland
United States Novartis Investigative Site Saint Louis Missouri
United States Novartis Investigative Site Salt Lake City Utah
United States Novartis Investigative Site Santa Ana California

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
baseline, 12 weeks
Secondary Change in Adiponectin Total Change from baseline in Adiponectin to measure adiposity baseline, 12 weeks
Secondary Change in Apolipoprotein B Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes baseline, 12 weeks
Secondary Change in CRP Change from baseline in C reactive protein (CRP), a measure of inflammation baseline, 12 weeks
Secondary Change in Cholesterol Change from baseline in Cholesterol level baseline, 12 weeks
Secondary Change in Fetuin A Change from baseline in Fetuin A, a marker predictive of diabetes baseline, 12 weeks
Secondary Change in Ferritin Change from baseline in Ferritin, a marker predictive of diabetes baseline, 12 weeks
Secondary Change in GlycA Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation baseline, 12 weeks
Secondary Change in HDL Cholesterol Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker baseline, 12 weeks
Secondary 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
baseline, 12 weeks
Secondary HDL Particle Total Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total baseline, 12 weeks
Secondary HDL Size Change from baseline in High Density Lipoprotein (HDL) Cholesterol size baseline, 12 weeks
Secondary HOMA-IR Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin [uIU/mL (mU/L)] x Glucose (mg/dL) = HOMA-IR baseline, 12 weeks
Secondary Change in IL-2 Receptor A Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes baseline, 12 weeks
Secondary Change in IL-18 Interleukin-18 (IL-18) is a marker predictive of diabetes baseline, 12 weeks
Secondary Change in IL-6 Interleukin 6 (IL-6) is a marker of inflammation baseline, 12 weeks
Secondary Change in Intermediate-Density Lipoprotein (IDL) Particle Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function baseline, 12 weeks
Secondary Change LDL Cholesterol Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function baseline, 12 weeks
Secondary Change in Leptin Change from baseline in Leptin a marker of adiposity baseline, 12 weeks
Secondary LDL Particle Total Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total baseline, 12 weeks
Secondary LDL Size Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size baseline, 12 weeks
Secondary Change in Triglycerides Triglycerides are a marker of cardiometabolic function baseline, 12 weeks
Secondary Change in TNF-a Change in Tumor necrosis factor (TNF, tumor necrosis factor alpha, TNFa is a marker of inflammation Also written as TNF-alpha baseline, 12 weeks
Secondary Change VLDL Particle Total Change in Very-low-density lipoprotein (VLDL) cholesterol level baseline, 12 weeks
Secondary VLDL Size Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size baseline, 12 weeks
Secondary 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).
week 12
Secondary 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 week 12
Secondary Psoriasis Area and Severity Index 100 (PASI100) Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis week 12
Secondary 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)
week 12
Secondary 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
baseline, 12 weeks
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