Phase 3
Completed N=151
Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab
Source: ClinicalTrials.gov NCT02559622 ↗Enrolled (actual)
151
Serious AEs
5.3%
Results posted
Jul 2017
Primary outcomePrimary: Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment — 5.23; 3.65 Percentage maximal increase in diameter — p=0.2230
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers were assessed to evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging (MRI) was performed in a sub-population to assess the treatment effect on arterial vessel wall morphometry in atherosclerosis prone vascular beds.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment |
5.23; 3.65 | 0.2230 |
| SECONDARY Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52 |
-0.7; -0.9; 0.7; 1.4; 0.5; 0.1 | — |
| SECONDARY Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52 |
0.0; 0.3; 1.1; -0.1; -0.5; 1.0 | — |
| SECONDARY Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52 |
0.0; -0.2; 0; -0.2; 0.4; 0.1 | — |
| SECONDARY Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12 |
15.35; 5.91; 9.92; 6.45; 2.69; -2.94 | — |
| SECONDARY Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52 |
14.42; 3.19; -15.11; 9.54; 3.97; 2.55 | — |
| SECONDARY Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52 |
0.0; -0.2; -0.0; 0.1; -0.0; -0.2 | — |
| SECONDARY Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52 |
-0.0; -0.0; 0.0; 0.0; -0.0; -0.0 | — |
| SECONDARY Change From Baseline in Chemokine (C-c Motif) Ligand 5 (CCL5), Monocyte Chemoattractant Protein 1 (MCP-1) and Macrophage Inflammatory Proteins (MIP) 1 Alpha and 1 Beta at Week 4, 12, 24 and 52 |
-1000; 1649; 27.0; -2000; 2116; 5185 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52 |
1.5; -1.6; 0.9; 0.2; 3.5; 1.1 | — |
| SECONDARY Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52 |
0.4; 0.4; -4.7; -0.5; -1.4; 1.1 | — |
| SECONDARY Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52 |
-18; -0.2; -28; -8.9; -16; 3.9 | — |
| SECONDARY Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52 |
0.3; 0.1; -1.1; -0.3; -0.1; 0.6 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52 |
0.2; -0.4; -0.7; -0.4; 0.4; -0.4 | — |
| SECONDARY Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52 |
0.1; 3.7; 4.7; -0.3; -0.1; 1.1 | — |
| SECONDARY Change From Baseline in Triglycerides, Total Cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB) at Week 4, 12, 24 and 52 |
-1.8; 6.5; 12.7; 27.5; -9.3; 4.0 | — |
| SECONDARY Change From Baseline in Adiponectin at Week 4, 12, 24 and 52 |
-0.5; 0.2; -0.1; -0.6; -0.5; -0.2 | — |
| SECONDARY Change From Baseline in Leptin at Week 4, 12, 24 and 52 |
-0.6; 1.0; -0.2; 0.3; 0.2; 0.1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization with a Psoriasis Area and Severity Index (PASI) score ≥ 10 at randomization.
- Inadequate response, intolerance or contraindication to cyclosporine, methotrexate and psoralen plus ultraviolet A light treatment (PUVA) as documented in the patient's medical history or reported by the patient or determined by the investigator at screening. Relative contraindications such as interference of patient's lifestyle with the treatment are accepted.
Key Exclusion Criteria
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttata psoriasis) at screening or randomization.
- Ongoing use of prohibited psoriasis and non-psoriasis treatments.
Data sourced from ClinicalTrials.gov (NCT02559622). 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.