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Completed

NCT Number: NCT02690701

Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis

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.

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Key information

Conditions

Chronic Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

secukinumab 300 mg

Drug

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.

Other names: AIN457 300 mg

Placebo

Biological

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.

Primary outcomes

  1. Aortic Vascular Inflammation as Measured by FDG-PET/CT

    Time frame: baseline, 12 weeks

    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)

Secondary outcomes

  1. Change in Adiponectin Total

    Time frame: baseline, 12 weeks

    Change from baseline in Adiponectin to measure adiposity

  2. Change in Apolipoprotein B

    Time frame: baseline, 12 weeks

    Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes

  3. Change in CRP

    Time frame: baseline, 12 weeks

    Change from baseline in C reactive protein (CRP), a measure of inflammation

  4. Change in Cholesterol

    Time frame: baseline, 12 weeks

    Change from baseline in Cholesterol level

  5. Change in Fetuin A

    Time frame: baseline, 12 weeks

    Change from baseline in Fetuin A, a marker predictive of diabetes

  6. Change in Ferritin

    Time frame: baseline, 12 weeks

    Change from baseline in Ferritin, a marker predictive of diabetes

  7. Change in GlycA

    Time frame: baseline, 12 weeks

    Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation

  8. Change in HDL Cholesterol

    Time frame: baseline, 12 weeks

    Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker

  9. Change in HDL Function (Cholesterol Efflux)

    Time frame: baseline, 12 weeks

    Change from baseline in High Density Lipoprotein (HDL) Cholesterol (cholesterol efflux) , a cardiometabolic biomarker

    Ratio of the pleated serum to removal of Cholesterol

  10. HDL Particle Total

    Time frame: baseline, 12 weeks

    Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total

  11. HDL Size

    Time frame: baseline, 12 weeks

    Change from baseline in High Density Lipoprotein (HDL) Cholesterol size

  12. HOMA-IR

    Time frame: baseline, 12 weeks

    Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin [uIU/mL (mU/L)] x Glucose (mg/dL) = HOMA-IR

  13. Change in IL-2 Receptor A

    Time frame: baseline, 12 weeks

    Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes

  14. Change in IL-18

    Time frame: baseline, 12 weeks

    Interleukin-18 (IL-18) is a marker predictive of diabetes

  15. Change in IL-6

    Time frame: baseline, 12 weeks

    Interleukin 6 (IL-6) is a marker of inflammation

  16. Change in Intermediate-Density Lipoprotein (IDL) Particle

    Time frame: baseline, 12 weeks

    Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function

  17. Change LDL Cholesterol

    Time frame: baseline, 12 weeks

    Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function

  18. Change in Leptin

    Time frame: baseline, 12 weeks

    Change from baseline in Leptin a marker of adiposity

  19. LDL Particle Total

    Time frame: baseline, 12 weeks

    Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total

  20. LDL Size

    Time frame: baseline, 12 weeks

    Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size

  21. Change in Triglycerides

    Time frame: baseline, 12 weeks

    Triglycerides are a marker of cardiometabolic function

  22. Change in TNF-α

    Time frame: baseline, 12 weeks

    Change in Tumor necrosis factor (TNF, tumor necrosis factor alpha, TNFα is a marker of inflammation Also written as TNF-alpha

  23. Change VLDL Particle Total

    Time frame: baseline, 12 weeks

    Change in Very-low-density lipoprotein (VLDL) cholesterol level

  24. VLDL Size

    Time frame: baseline, 12 weeks

    Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size

  25. Area and Severity Index 75 (PASI 75)

    Time frame: week 12

    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).

  26. Psoriasis Area and Severity Index 90 (PASI 90)

    Time frame: week 12

    Percentage of participants with PASI90 response (yes, no) PASI90 response = at least a 90& improvement (reduction) in PASI score compared to baseline

  27. Psoriasis Area and Severity Index 100 (PASI100)

    Time frame: week 12

    Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis

  28. Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1

    Time frame: week 12

    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)

  29. Dermatology Life Quality Index (DLQI) Total Score

    Time frame: baseline, 12 weeks

    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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers After 12 Weeks of Treatment, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Acronym: VIP-S

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 24, 2016
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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