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CompletedNCT02690701VIP-SUpdated Jan 5, 2021Results posted

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

A Phase 4 interventional study of Secukinumab 300 mg and Placebo in Chronic Plaque Psoriasis, sponsored by Novartis Pharmaceuticals. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Plaque Psoriasis

Keywords

  • psoriasis
  • plaque psoriasis
  • secukinumab
  • AIN457
  • biologic
  • monoclonal antibody
  • aortic vascular inflammation
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 91 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Males and females at least 18 years of age with moderate to severe plaque psoriasis

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
91 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugSecukinumab 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.

    Also known as: AIN457 300 mg

  • BiologicalPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: baseline, 12 weeks

Secondary outcomes

  1. Change in Adiponectin Total

    Change from baseline in Adiponectin to measure adiposity

    Time frame: baseline, 12 weeks

  2. Change in Apolipoprotein B

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

    Time frame: baseline, 12 weeks

  3. Change in CRP

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

    Time frame: baseline, 12 weeks

  4. Change in Cholesterol

    Change from baseline in Cholesterol level

    Time frame: baseline, 12 weeks

  5. Change in Fetuin A

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

    Time frame: baseline, 12 weeks

  6. Change in Ferritin

    Change from baseline in Ferritin, a marker predictive of diabetes

    Time frame: baseline, 12 weeks

  7. Change in GlycA

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

    Time frame: baseline, 12 weeks

  8. Change in HDL Cholesterol

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

    Time frame: baseline, 12 weeks

  9. 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

    Time frame: baseline, 12 weeks

  10. HDL Particle Total

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

    Time frame: baseline, 12 weeks

  11. HDL Size

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

    Time frame: baseline, 12 weeks

  12. HOMA-IR

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

    Time frame: baseline, 12 weeks

  13. Change in IL-2 Receptor A

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

    Time frame: baseline, 12 weeks

  14. Change in IL-18

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

    Time frame: baseline, 12 weeks

  15. Change in IL-6

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

    Time frame: baseline, 12 weeks

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

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

    Time frame: baseline, 12 weeks

  17. Change LDL Cholesterol

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

    Time frame: baseline, 12 weeks

  18. Change in Leptin

    Change from baseline in Leptin a marker of adiposity

    Time frame: baseline, 12 weeks

  19. LDL Particle Total

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

    Time frame: baseline, 12 weeks

  20. LDL Size

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

    Time frame: baseline, 12 weeks

  21. Change in Triglycerides

    Triglycerides are a marker of cardiometabolic function

    Time frame: baseline, 12 weeks

  22. 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

    Time frame: baseline, 12 weeks

  23. Change VLDL Particle Total

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

    Time frame: baseline, 12 weeks

  24. VLDL Size

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

    Time frame: baseline, 12 weeks

  25. 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).

    Time frame: week 12

  26. 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

    Time frame: week 12

  27. Psoriasis Area and Severity Index 100 (PASI100)

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

    Time frame: week 12

  28. 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)

    Time frame: week 12

  29. 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

    Time frame: baseline, 12 weeks

07

Results

Posted Jul 9, 2019

Participant flow

Randomized Set consisted of all 91 participants who were randomly assigned to a treatment group

Treatment Period 1
Participant flow — Treatment Period 1
MilestoneSecukinumabPlacebo
Started4645
Completed4442
Not completed23
Withdrew: Adverse event22
Withdrew: Withdrawal by subject01
Treatment Period 2
Participant flow — Treatment Period 2
MilestoneSecukinumabPlacebo
Started4442
Completed4137
Not completed35
Withdrew: Adverse event20
Withdrew: Lack of efficacy10
Withdrew: Lost to follow-up02
Withdrew: Withdrawal by subject02
Withdrew: Protocol violation01

Outcome measures

PrimaryAortic 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)

Time frame:
baseline, 12 weeks
Reported as:
Mean · target to background ratio (TBR)
Aortic Vascular Inflammation as Measured by FDG-PET/CT
target to background ratio (TBR)SecukinumabPlacebo
Baseline1.6615 ± 0.373801.6333 ± 0.33228
Change from Baseline at Week 120.0143 ± 0.255200.0655 ± 0.28086
Statistical analysis
  • Secukinumab vs Placebo · ANCOVA · p = 0.3712 · Least square mean: -0.053 · 95% CI -0.169 to 0.064
SecondaryChange in Adiponectin Total

Change from baseline in Adiponectin to measure adiposity

Time frame:
baseline, 12 weeks
Reported as:
Mean · ng/mL
Change in Adiponectin Total
ng/mLSecukinumabPlacebo
Baseline18799.0 ± 18608.4819475.00 ± 18343.00
Change from Baseline at Week 121594.90 ± 15146.84-1076.40 ± 14565.60
SecondaryChange in Apolipoprotein B

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · ng/mL
Change in Apolipoprotein B
ng/mLSecukinumabPlacebo
Baseline0.1014 ± 0.046510.1033 ± 0.04451
Change from Baseline at Week 120.0020 ± 0.063310.0017 ± 0.04835
SecondaryChange in CRP

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · mg/L
Change in CRP
mg/LSecukinumabPlacebo
Baseline6.1525 ± 8.230167.8676 ± 7.59860
Change from Baseline at Week 12-1.0016 ± 9.452811.1622 ± 15.84088
SecondaryChange in Cholesterol

Change from baseline in Cholesterol level

Time frame:
baseline, 12 weeks
Reported as:
Mean · mg/dL
Change in Cholesterol
mg/dLSecukinumabPlacebo
Baseline179.350 ± 30.01243178.707 ± 38.92573
Change from Baseline at Week 1210.6000 ± 30.27379-8.4878 ± 35.18247
SecondaryChange in Fetuin A

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · ng/mL
Change in Fetuin A
ng/mLSecukinumabPlacebo
Baseline988677.800781 ± 488494.34910431169947.724848 ± 79644.6884632
Change from Baseline at Week 1290810.212003 ± 444791.470046145731.298018 ± 452743.5932412
SecondaryChange in Ferritin

Change from baseline in Ferritin, a marker predictive of diabetes

Time frame:
baseline, 12 weeks
Reported as:
Mean · ng/mL
Change in Ferritin
ng/mLSecukinumabPlacebo
Baseline111.953 ± 91.17931122.040 ± 114.8715
Change from Baseline at Week 12-6.1006 ± 60.71995-17.118 ± 63.86703
SecondaryChange in GlycA

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · μmol/L
Change in GlycA
μmol/LSecukinumabPlacebo
Baseline413.860 ± 65.34929439.622 ± 60.44873
Change from Baseline at Week 120.5152 ± 59.46394-1.5420 ± 40.25958
SecondaryChange in HDL Cholesterol

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · mg/dL
Change in HDL Cholesterol
mg/dLSecukinumabPlacebo
Baseline43.3000 ± 10.2035743.0732 ± 12.52276
Change from Baseline at Week 12-0.7500 ± 8.80195-1.1220 ± 8.10924
SecondaryChange 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

Time frame:
baseline, 12 weeks
Reported as:
Mean · ratio
Change in HDL Function (Cholesterol Efflux)
ratioSecukinumabPlacebo
Baseline0.9535 ± 0.189861.0456 ± 0.17819
Change from Baseline at Week 120.1473 ± 0.232620.0541 ± 0.21902
SecondaryHDL Particle Total

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · μmol/L
HDL Particle Total
μmol/LSecukinumabPlacebo
Baseline29.2875 ± 5.3818429.3634 ± 6.27442
Change from Baseline at Week 12-0.1375 ± 5.22900-0.1707 ± 5.12973
SecondaryHDL Size

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · nm
HDL Size
nmSecukinumabPlacebo
Baseline8.9350 ± 0.532808.9585 ± 0.56656
Change from Baseline at Week 120.0500 ± 0.479320.0073 ± 0.34161
SecondaryHOMA-IR

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · HOMA-IR units
HOMA-IR
HOMA-IR unitsSecukinumabPlacebo
Baseline3.4901 ± 3.024795.5112 ± 6.22334
Change from Baseline at Week 120.9563 ± 2.23669-1.2764 ± 5.13505
SecondaryChange in IL-2 Receptor A

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · pg/mL
Change in IL-2 Receptor A
pg/mLSecukinumabPlacebo
Baseline25.5554 ± 59.4723221.0665 ± 61.46295
Change from Baseline at Week 12-3.3606 ± 38.52458-1.1162 ± 6.31189
SecondaryChange in IL-18

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · pg/mL
Change in IL-18
pg/mLSecukinumabPlacebo
Baseline1259.45 ± 1910.3271308.47 ± 2454.672
Change from Baseline at Week 1234555.1 ± 231199.6-627.77 ± 1874.377
SecondaryChange in IL-6

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · pg/mL
Change in IL-6
pg/mLSecukinumabPlacebo
Baseline5.6477 ± 20.812421.6658 ± 1.50954
Change from Baseline at Week 120.1334 ± 29.35524-0.0900 ± 1.78692
SecondaryChange in Intermediate-Density Lipoprotein (IDL) Particle

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · nmol/mL
Change in Intermediate-Density Lipoprotein (IDL) Particle
nmol/mLSecukinumabPlacebo
Baseline284.350 ± 179.6482271.049 ± 155.7413
Change from Baseline at Week 1247.0500 ± 167.62532.3902 ± 160.6046
SecondaryChange LDL Cholesterol

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · mg/dL
Change LDL Cholesterol
mg/dLSecukinumabPlacebo
Baseline122.475 ± 28.86040121.049 ± 36.39708
Change from Baseline at Week 129.9750 ± 29.84532-6.2927 ± 34.42401
SecondaryChange in Leptin

Change from baseline in Leptin a marker of adiposity

Time frame:
baseline, 12 weeks
Reported as:
Mean · pg/mL
Change in Leptin
pg/mLSecukinumabPlacebo
Baseline19913.4 ± 21835.6636813.3 ± 62138.25
Change from Baseline at Week 12-1886.0 ± 11701.00-5595.9 ± 17042.08
SecondaryLDL Particle Total

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · nmol/L
LDL Particle Total
nmol/LSecukinumabPlacebo
Baseline1236.35 ± 317.95421263.00 ± 447.3457
Change from Baseline at Week 12114.250 ± 294.8695-111.39 ± 343.2109
SecondaryLDL Size

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · nm
LDL Size
nmSecukinumabPlacebo
Baseline21.2200 ± 0.7497721.1171 ± 0.76384
Change from Baseline at Week 12-0.0025 ± 0.700360.1439 ± 0.53807
SecondaryChange in Triglycerides

Triglycerides are a marker of cardiometabolic function

Time frame:
baseline, 12 weeks
Reported as:
Mean · mg/dL
Change in Triglycerides
mg/dLSecukinumabPlacebo
Baseline123.200 ± 52.90398125.293 ± 79.10633
Change from Baseline at Week 1211.5000 ± 62.56279-10.732 ± 60.25281
SecondaryChange in TNF-α

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
Reported as:
Mean · pg/mL
Change in TNF-α
pg/mLSecukinumabPlacebo
Baseline2.3919 ± 1.790492.8089 ± 4.11492
Change from Baseline at Week 12-0.3577 ± 1.52948-0.9818 ± 3.85715
SecondaryChange VLDL Particle Total

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · nmol/L
Change VLDL Particle Total
nmol/LSecukinumabPlacebo
Baseline52.9125 ± 26.9210254.5829 ± 27.57024
Change from Baseline at Week 123.2500 ± 28.564213.2024 ± 25.40299
SecondaryVLDL Size

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

Time frame:
baseline, 12 weeks
Reported as:
Mean · nm
VLDL Size
nmSecukinumabPlacebo
Baseline51.5650 ± 9.1115250.1195 ± 9.51641
Change from Baseline at Week 12-0.3950 ± 9.30271-0.7927 ± 7.72572
SecondaryArea 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).

Time frame:
week 12
Reported as:
Number · percentage of participants
Area and Severity Index 75 (PASI 75)
percentage of participantsSecukinumabPlacebo
Area and Severity Index 75 (PASI 75)84.80.0
SecondaryPsoriasis 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

Time frame:
week 12
Reported as:
Number · percentage of participants
Psoriasis Area and Severity Index 90 (PASI 90)
percentage of participantsSecukinumabPlacebo
Psoriasis Area and Severity Index 90 (PASI 90)73.90.0
SecondaryPsoriasis Area and Severity Index 100 (PASI100)

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

Time frame:
week 12
Reported as:
Number · percentage of participants
Psoriasis Area and Severity Index 100 (PASI100)
percentage of participantsSecukinumabPlacebo
Psoriasis Area and Severity Index 100 (PASI100)37.00.0
SecondaryInvestigator'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)

Time frame:
week 12
Reported as:
Number · percentage of participants
Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1
percentage of participantsSecukinumabPlacebo
Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 178.30.0
SecondaryDermatology 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

Time frame:
baseline, 12 weeks
Reported as:
Mean · scores on a scale
Dermatology Life Quality Index (DLQI) Total Score
scores on a scaleSecukinumabPlacebo
Baseline12.30 ± 7.6512.6 ± 7.21
Change from baseline at Week 12-9.4 ± 7.91-0.5 ± 3.97

Adverse events

Collected over Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Secukinumab 300 mg0/46 (0%)5/46 (10.9%)21/46 (45.7%)
Placebo/Secukinumab 300 mg0/45 (0%)0/45 (0%)18/45 (40%)
Total0/91 (0%)5/91 (5.5%)39/91 (42.9%)
Most frequent serious events
Most frequent serious events
EventSecukinumab 300 mgPlacebo/Secukinumab 300 mgTotal
Abdominal painGastrointestinal disorders1/460/451/91
Rib fractureInjury, poisoning and procedural complications1/460/451/91
Upper limb fractureInjury, poisoning and procedural complications1/460/451/91
Muscular weaknessMusculoskeletal and connective tissue disorders1/460/451/91
Aortic stenosisVascular disorders1/460/451/91
Most frequent other events
Most frequent other events
EventSecukinumab 300 mgPlacebo/Secukinumab 300 mgTotal
NasopharyngitisInfections and infestations9/467/4516/91
Upper respiratory tract infectionInfections and infestations6/464/4510/91
ArthralgiaMusculoskeletal and connective tissue disorders5/463/458/91
HeadacheNervous system disorders0/464/454/91
CoughRespiratory, thoracic and mediastinal disorders1/464/455/91
SinusitisInfections and infestations0/463/453/91
DizzinessNervous system disorders1/463/454/91
DiarrhoeaGastrointestinal disorders3/462/455/91
BronchitisInfections and infestations3/460/453/91

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)SecukinumabPlaceboTotal
<=18 years000
Between 18 and 65 years413980
>=65 years5611
Sex: Female, Male
Sex: Female, Male(Participants)SecukinumabPlaceboTotal
Female131730
Male332861
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SecukinumabPlaceboTotal
Caucasian363672
Black134
Asian628
Other347
08

Study locations

12 sites
  • Novartis Investigative Site
    Los Angeles, California 90033, United States
  • Novartis Investigative Site
    Santa Ana, California 92701, United States
  • Novartis Investigative Site
    Rockville, Maryland 20850, United States
  • Novartis Investigative Site
    Saint Louis, Missouri 63117, United States
  • Novartis Investigative Site
    Buffalo, New York 14221, United States
  • Novartis Investigative Site
    New York, New York 10025 1737, United States
  • Novartis Investigative Site
    Portland, Oregon 97223, United States
  • Novartis Investigative Site
    Portland, Oregon 97239, United States
  • Novartis Investigative Site
    Exton, Pennsylvania 19341, United States
  • Novartis Investigative Site
    Dallas, Texas 75246-1613, United States
  • Novartis Investigative Site
    Houston, Texas 77004, United States
  • Novartis Investigative Site
    Salt Lake City, Utah 84132, United States
09

References and documents

Publications

  • 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. PubMed 32088207 ↗

Study documents

  • Study protocol · Feb 27, 2018
  • Statistical analysis plan · Aug 2, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02690701
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Feb 24, 2016
Start date
Feb 10, 2016
Primary completion
Apr 26, 2017
Completion
Feb 19, 2018
Results posted
Jul 9, 2019
Last update
Jan 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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