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

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ClinicalTrials.gov Identifier: NCT02690701
Recruitment Status : Completed
First Posted : February 24, 2016
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Secukinumab 300 mg Biological: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 10, 2016
Actual Primary Completion Date : April 26, 2017
Actual Study Completion Date : February 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab
Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 48 inclusive
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.

Other Name: AIN457 300 mg

Placebo Comparator: Placebo then Secukinumab

Eligible patients received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8.

Beginning with the Week 12 dose, participants were switched to treatment with secukinumab 300 mg and were dosed once weekly at Weeks 12, 13, 14, 15 and 16 followed by monthly dosing through Week 48 inclusive.

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690701


Locations
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United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90033
Novartis Investigative Site
Santa Ana, California, United States, 92701
United States, Maryland
Novartis Investigative Site
Rockville, Maryland, United States, 20850
United States, Missouri
Novartis Investigative Site
Saint Louis, Missouri, United States, 63117
United States, New York
Novartis Investigative Site
Buffalo, New York, United States, 14221
Novartis Investigative Site
New York, New York, United States, 10025 1737
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States, 97223
Novartis Investigative Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novartis Investigative Site
Exton, Pennsylvania, United States, 19341
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75246-1613
Novartis Investigative Site
Houston, Texas, United States, 77004
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] February 27, 2018
Statistical Analysis Plan  [PDF] August 2, 2018


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02690701     History of Changes
Other Study ID Numbers: CAIN457AUS02
First Posted: February 24, 2016    Key Record Dates
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
psoriasis
plaque psoriasis
secukinumab
AIN457
biologic
monoclonal antibody
aortic vascular inflammation
Additional relevant MeSH terms:
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Psoriasis
Inflammation
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs