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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)

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Secukinumab 300 mg
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, aortic vascular inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Secukinumab

Placebo then Secukinumab

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2016
Last Updated
December 9, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02690701
Brief Title
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
Acronym
VIP-S
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2016 (Actual)
Primary Completion Date
April 26, 2017 (Actual)
Study Completion Date
February 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, aortic vascular inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo then Secukinumab
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Secukinumab 300 mg
Other Intervention Name(s)
AIN457 300 mg
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Aortic Vascular Inflammation as Measured by FDG-PET/CT
Description
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
Secondary Outcome Measure Information:
Title
Change in Adiponectin Total
Description
Change from baseline in Adiponectin to measure adiposity
Time Frame
baseline, 12 weeks
Title
Change in Apolipoprotein B
Description
Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes
Time Frame
baseline, 12 weeks
Title
Change in CRP
Description
Change from baseline in C reactive protein (CRP), a measure of inflammation
Time Frame
baseline, 12 weeks
Title
Change in Cholesterol
Description
Change from baseline in Cholesterol level
Time Frame
baseline, 12 weeks
Title
Change in Fetuin A
Description
Change from baseline in Fetuin A, a marker predictive of diabetes
Time Frame
baseline, 12 weeks
Title
Change in Ferritin
Description
Change from baseline in Ferritin, a marker predictive of diabetes
Time Frame
baseline, 12 weeks
Title
Change in GlycA
Description
Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation
Time Frame
baseline, 12 weeks
Title
Change in HDL Cholesterol
Description
Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker
Time Frame
baseline, 12 weeks
Title
Change in HDL Function (Cholesterol Efflux)
Description
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
Title
HDL Particle Total
Description
Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total
Time Frame
baseline, 12 weeks
Title
HDL Size
Description
Change from baseline in High Density Lipoprotein (HDL) Cholesterol size
Time Frame
baseline, 12 weeks
Title
HOMA-IR
Description
Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin [uIU/mL (mU/L)] x Glucose (mg/dL) = HOMA-IR
Time Frame
baseline, 12 weeks
Title
Change in IL-2 Receptor A
Description
Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes
Time Frame
baseline, 12 weeks
Title
Change in IL-18
Description
Interleukin-18 (IL-18) is a marker predictive of diabetes
Time Frame
baseline, 12 weeks
Title
Change in IL-6
Description
Interleukin 6 (IL-6) is a marker of inflammation
Time Frame
baseline, 12 weeks
Title
Change in Intermediate-Density Lipoprotein (IDL) Particle
Description
Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function
Time Frame
baseline, 12 weeks
Title
Change LDL Cholesterol
Description
Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function
Time Frame
baseline, 12 weeks
Title
Change in Leptin
Description
Change from baseline in Leptin a marker of adiposity
Time Frame
baseline, 12 weeks
Title
LDL Particle Total
Description
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total
Time Frame
baseline, 12 weeks
Title
LDL Size
Description
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size
Time Frame
baseline, 12 weeks
Title
Change in Triglycerides
Description
Triglycerides are a marker of cardiometabolic function
Time Frame
baseline, 12 weeks
Title
Change in TNF-α
Description
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
Title
Change VLDL Particle Total
Description
Change in Very-low-density lipoprotein (VLDL) cholesterol level
Time Frame
baseline, 12 weeks
Title
VLDL Size
Description
Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size
Time Frame
baseline, 12 weeks
Title
Area and Severity Index 75 (PASI 75)
Description
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
Title
Psoriasis Area and Severity Index 90 (PASI 90)
Description
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
Title
Psoriasis Area and Severity Index 100 (PASI100)
Description
Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis
Time Frame
week 12
Title
Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1
Description
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
Title
Dermatology Life Quality Index (DLQI) Total Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Novartis Investigative Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Novartis Investigative Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10025 1737
Country
United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Novartis Investigative Site
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-1613
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Novartis Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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
Citations:
PubMed Identifier
32088207
Citation
Gelfand JM, Shin DB, Duffin KC, Armstrong AW, Blauvelt A, Tyring SK, Menter A, Gottlieb S, Lockshin BN, Simpson EL, Kianifard F, Sarkar RP, Muscianisi E, Steadman J, Ahlman MA, Playford MP, Joshi AA, Dey AK, Werner TJ, Alavi A, Mehta NN. A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S). J Invest Dermatol. 2020 Sep;140(9):1784-1793.e2. doi: 10.1016/j.jid.2020.01.025. Epub 2020 Feb 21.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=411
Description
A Plain Language Trial Summary is available on novartisclinicatrials.com

Learn more about this trial

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

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