Phase 4
Completed N=91
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT02690701 ↗Enrolled (actual)
91
Serious AEs
5.5%
Results posted
Jul 2019
Primary outcomePrimary: Aortic Vascular Inflammation as Measured by FDG-PET/CT — 1.6615; 1.6333; 0.0143; 0.0655 target to background ratio (TBR) — p=0.3712
◆ Published Evidence
Established
98citations · ~16 / year
A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S).
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.
Linked Publications
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A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aortic Vascular Inflammation as Measured by FDG-PET/CT |
1.6615; 1.6333; 0.0143; 0.0655 | 0.3712 |
| SECONDARY Change in Adiponectin Total |
18799.0; 19475.00; 1594.90; -1076.40 | — |
| SECONDARY Change in Apolipoprotein B |
0.1014; 0.1033; 0.0020; 0.0017 | — |
| SECONDARY Change in CRP |
6.1525; 7.8676; -1.0016; 1.1622 | — |
| SECONDARY Change in Cholesterol |
179.350; 178.707; 10.6000; -8.4878 | — |
| SECONDARY Change in Fetuin A |
988677.800781; 1169947.724848; 90810.212003; 45731.298018 | — |
| SECONDARY Change in Ferritin |
111.953; 122.040; -6.1006; -17.118 | — |
| SECONDARY Change in GlycA |
413.860; 439.622; 0.5152; -1.5420 | — |
| SECONDARY Change in HDL Cholesterol |
43.3000; 43.0732; -0.7500; -1.1220 | — |
| SECONDARY Change in HDL Function (Cholesterol Efflux) |
0.9535; 1.0456; 0.1473; 0.0541 | — |
| SECONDARY HDL Particle Total |
29.2875; 29.3634; -0.1375; -0.1707 | — |
| SECONDARY HDL Size |
8.9350; 8.9585; 0.0500; 0.0073 | — |
| SECONDARY HOMA-IR |
3.4901; 5.5112; 0.9563; -1.2764 | — |
| SECONDARY Change in IL-2 Receptor A |
25.5554; 21.0665; -3.3606; -1.1162 | — |
| SECONDARY Change in IL-18 |
1259.45; 1308.47; 34555.1; -627.77 | — |
| SECONDARY Change in IL-6 |
5.6477; 1.6658; 0.1334; -0.0900 | — |
| SECONDARY Change in Intermediate-Density Lipoprotein (IDL) Particle |
284.350; 271.049; 47.0500; 2.3902 | — |
| SECONDARY Change LDL Cholesterol |
122.475; 121.049; 9.9750; -6.2927 | — |
| SECONDARY Change in Leptin |
19913.4; 36813.3; -1886.0; -5595.9 | — |
| SECONDARY LDL Particle Total |
1236.35; 1263.00; 114.250; -111.39 | — |
| SECONDARY LDL Size |
21.2200; 21.1171; -0.0025; 0.1439 | — |
| SECONDARY Change in Triglycerides |
123.200; 125.293; 11.5000; -10.732 | — |
| SECONDARY Change in TNF-α |
2.3919; 2.8089; -0.3577; -0.9818 | — |
| SECONDARY Change VLDL Particle Total |
52.9125; 54.5829; 3.2500; 3.2024 | — |
| SECONDARY VLDL Size |
51.5650; 50.1195; -0.3950; -0.7927 | — |
| SECONDARY Area and Severity Index 75 (PASI 75) |
84.8; 0.0 | — |
| SECONDARY Psoriasis Area and Severity Index 90 (PASI 90) |
73.9; 0.0 | — |
| SECONDARY Psoriasis Area and Severity Index 100 (PASI100) |
37.0; 0.0 | — |
| SECONDARY Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1 |
78.3; 0.0 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Total Score |
12.30; 12.6; -9.4; -0.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT02690701) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.