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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 )

Tracking Information
First Submitted Date  ICMJE February 19, 2016
First Posted Date  ICMJE February 24, 2016
Results First Submitted Date  ICMJE February 19, 2019
Results First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE February 10, 2016
Actual Primary Completion Date April 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
Aortic Vascular Inflammation as Measured by FDG-PET/CT [ Time Frame: 12 weeks ]
Change from baseline in the target to background ratio from the aorta
Change History Complete list of historical versions of study NCT02690701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Change in Adiponectin Total [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Adiponectin to measure adiposity
  • Change in Apolipoprotein B [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes
  • Change in CRP [ Time Frame: baseline, 12 weeks ]
    Change from baseline in C reactive protein (CRP), a measure of inflammation
  • Change in Cholesterol [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Cholesterol level
  • Change in Fetuin A [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Fetuin A, a marker predictive of diabetes
  • Change in Ferritin [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Ferritin, a marker predictive of diabetes
  • Change in GlycA [ Time Frame: baseline, 12 weeks ]
    Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation
  • Change in HDL Cholesterol [ Time Frame: baseline, 12 weeks ]
    Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker
  • 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
  • HDL Particle Total [ Time Frame: baseline, 12 weeks ]
    Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total
  • HDL Size [ Time Frame: baseline, 12 weeks ]
    Change from baseline in High Density Lipoprotein (HDL) Cholesterol size
  • 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
  • Change in IL-2 Receptor A [ Time Frame: baseline, 12 weeks ]
    Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes
  • Change in IL-18 [ Time Frame: baseline, 12 weeks ]
    Interleukin-18 (IL-18) is a marker predictive of diabetes
  • Change in IL-6 [ Time Frame: baseline, 12 weeks ]
    Interleukin 6 (IL-6) is a marker of inflammation
  • Change in Intermediate-Density Lipoprotein (IDL) Particle [ Time Frame: baseline, 12 weeks ]
    Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function
  • Change LDL Cholesterol [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function
  • Change in Leptin [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Leptin a marker of adiposity
  • LDL Particle Total [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total
  • LDL Size [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size
  • Change in Triglycerides [ Time Frame: baseline, 12 weeks ]
    Triglycerides are a marker of cardiometabolic function
  • 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
  • Change VLDL Particle Total [ Time Frame: baseline, 12 weeks ]
    Change in Very-low-density lipoprotein (VLDL) cholesterol level
  • VLDL Size [ Time Frame: baseline, 12 weeks ]
    Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size
  • 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).
  • 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
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • Cardiometabolic biomarkers [ Time Frame: 12 weeks ]
    Change from baseline in cardiometabolic biomarkers
  • Psoriasis Area and Severity Index 75 (PASI 75) [ Time Frame: 12 weeks ]
    PASI 75 response (yes, no)
  • Psoriasis Area and Severity Index 90 (PASI 90) [ Time Frame: 12 weeks ]
    PASI 90 response (yes, no)
  • Psoriasis Area and Severity Index 100 (PASI 100) [ Time Frame: 12 weeks ]
    PASI 100 response (yes, no)
  • Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 [ Time Frame: 12 weeks ]
    IGA mod 2011 score of 0 or 1 (yes, no)
  • Dermatology Quality of Life Index (DLQI) total score [ Time Frame: 12 weeks ]
    Change from baseline in the DLQI total score
  • Number of patients with Adverse Events, Serious Adverse Events or Death [ Time Frame: 52 weeks ]
    Assessment of safety and tolerability of secukinumab by vital signs, labs, and adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Plaque Psoriasis
Intervention  ICMJE
  • 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
  • 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.

Study Arms  ICMJE
  • 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
    Intervention: Drug: Secukinumab 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.

    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2018)
91
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2016)
84
Actual Study Completion Date  ICMJE February 19, 2018
Actual Primary Completion Date April 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02690701
Other Study ID Numbers  ICMJE CAIN457AUS02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP