NCT02690701: VIP-S

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

Completed Phase 4 Results posted Last updated 5 January 2021

What this trial tests

Phase 4 trial testing Secukinumab 300 mg in Chronic Plaque Psoriasis in 91 participants. Completed in 19 February 2018.

Timeline

10 February 2016

Primary endpoint
26 April 2017

19 February 2018

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	91
Start date	10 February 2016
Primary completion	26 April 2017
Estimated completion	19 February 2018
Sites	12 locations across United States

Drugs / interventions tested

• Secukinumab 300 mg — full drug profile →
• Placebo

Conditions studied

• Chronic Plaque Psoriasis — all drugs for Chronic Plaque Psoriasis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Chronic Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Aortic Vascular Inflammation as Measured by FDG-PET/CT Primary · 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)

Baseline

Group	Value	95% CI
Secukinumab	1.6615	± 0.37380
Placebo	1.6333	± 0.33228

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	0.0143	± 0.25520
Placebo	0.0655	± 0.28086

Change in Adiponectin Total Secondary · baseline, 12 weeks

Change from baseline in Adiponectin to measure adiposity

Baseline

Group	Value	95% CI
Secukinumab	18799.0	± 18608.48
Placebo	19475.00	± 18343.00

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	1594.90	± 15146.84
Placebo	-1076.40	± 14565.60

Change in Apolipoprotein B Secondary · baseline, 12 weeks

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

Baseline

Group	Value	95% CI
Secukinumab	0.1014	± 0.04651
Placebo	0.1033	± 0.04451

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	0.0020	± 0.06331
Placebo	0.0017	± 0.04835

Change in CRP Secondary · baseline, 12 weeks

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

Baseline

Group	Value	95% CI
Secukinumab	6.1525	± 8.23016
Placebo	7.8676	± 7.59860

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	-1.0016	± 9.45281
Placebo	1.1622	± 15.84088

Change in Cholesterol Secondary · baseline, 12 weeks

Change from baseline in Cholesterol level

Baseline

Group	Value	95% CI
Secukinumab	179.350	± 30.01243
Placebo	178.707	± 38.92573

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	10.6000	± 30.27379
Placebo	-8.4878	± 35.18247

Change in Fetuin A Secondary · baseline, 12 weeks

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

Baseline

Group	Value	95% CI
Secukinumab	988677.800781	± 488494.3491043
Placebo	1169947.724848	± 79644.6884632

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	90810.212003	± 444791.4700461
Placebo	45731.298018	± 452743.5932412

Change in Ferritin Secondary · baseline, 12 weeks

Change from baseline in Ferritin, a marker predictive of diabetes

Baseline

Group	Value	95% CI
Secukinumab	111.953	± 91.17931
Placebo	122.040	± 114.8715

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	-6.1006	± 60.71995
Placebo	-17.118	± 63.86703

Change in GlycA Secondary · baseline, 12 weeks

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

Baseline

Group	Value	95% CI
Secukinumab	413.860	± 65.34929
Placebo	439.622	± 60.44873

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	0.5152	± 59.46394
Placebo	-1.5420	± 40.25958

Change in HDL Cholesterol Secondary · baseline, 12 weeks

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

Baseline

Group	Value	95% CI
Secukinumab	43.3000	± 10.20357
Placebo	43.0732	± 12.52276

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	-0.7500	± 8.80195
Placebo	-1.1220	± 8.10924

Change in HDL Function (Cholesterol Efflux) Secondary · 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

Baseline

Group	Value	95% CI
Secukinumab	0.9535	± 0.18986
Placebo	1.0456	± 0.17819

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	0.1473	± 0.23262
Placebo	0.0541	± 0.21902

HDL Particle Total Secondary · baseline, 12 weeks

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

Baseline

Group	Value	95% CI
Secukinumab	29.2875	± 5.38184
Placebo	29.3634	± 6.27442

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	-0.1375	± 5.22900
Placebo	-0.1707	± 5.12973

HDL Size Secondary · baseline, 12 weeks

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

Baseline

Group	Value	95% CI
Secukinumab	8.9350	± 0.53280
Placebo	8.9585	± 0.56656

Change from Baseline at Week 12

Group	Value	95% CI
Secukinumab	0.0500	± 0.47932
Placebo	0.0073	± 0.34161

Adverse events — posted to ClinicalTrials.gov

Time frame: 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. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Secukinumab 300 mg

Serious: 5/46 (11%)

Deaths: 0/46

Placebo/Secukinumab 300 mg

Serious: 0/45 (0%)

Deaths: 0/45

Total

Serious: 5/91 (5%)

Deaths: 0/91

Serious adverse events (5 terms)

Reaction	System	Secukinumab 300 mg	Placebo/Secukinumab 300 mg	Total
Abdominal pain	Gastrointestinal disorders	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—
Upper limb fracture	Injury, poisoning and procedural complications	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—
Aortic stenosis	Vascular disorders	—	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Secukinumab 300 mg	Placebo/Secukinumab 300 mg	Total
Nasopharyngitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—

Most-reported serious reactions: Abdominal pain, Rib fracture, Upper limb fracture, Muscular weakness, Aortic stenosis.

Data from ClinicalTrials.gov NCT02690701 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Immunologic Role of IL-17 in Psoriasis and Psoriatic Arthritis Pathogenesis.
   Blauvelt A, Chiricozzi A. · · 2018 · cited 531× · PMID 30109481 · DOI 10.1007/s12016-018-8702-3
2. Management of psoriasis as a systemic disease: what is the evidence?
   Korman NJ. · · 2020 · cited 347× · PMID 31225638 · DOI 10.1111/bjd.18245
3. Psoriasis and comorbid diseases: Implications for management.
   Takeshita J, Grewal S, Langan SM, Mehta NN, et al · · 2017 · cited 154× · PMID 28212760 · DOI 10.1016/j.jaad.2016.07.065
4. Psoriasis and metabolic syndrome: implications for the management and treatment of psoriasis.
   Wu JJ, Kavanaugh A, Lebwohl MG, Gniadecki R, et al · · 2022 · cited 145× · PMID 35238067 · DOI 10.1111/jdv.18044
5. Cardiovascular Risk in Patients With Psoriasis: JACC Review Topic of the Week.
   Garshick MS, Ward NL, Krueger JG, Berger JS. · · 2021 · cited 143× · PMID 33795041 · DOI 10.1016/j.jacc.2021.02.009
6. Coronary Plaque Characterization in Psoriasis Reveals High-Risk Features That Improve After Treatment in a Prospective Observational Study.
   Lerman JB, Joshi AA, Chaturvedi A, Aberra TM, et al · · 2017 · cited 131× · PMID 28483812 · DOI 10.1161/circulationaha.116.026859
7. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Garcia-Doval I, Do G, et al · · 2017 · cited 106× · PMID 29271481 · DOI 10.1002/14651858.cd011535.pub2
8. A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S).
   Gelfand JM, Shin DB, Duffin KC, Armstrong AW, et al · · 2020 · cited 78× · PMID 32088207 · DOI 10.1016/j.jid.2020.01.025