Clinical trial NCT02559622: Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Exploratory Evaluation of Surrogate Markers of Cardiovascular Risk in Patients With Active Chronic Plaque-type Psoriasis Treated for up to 52 Weeks With Subcutaneous (s.c.) Secukinumab (300 mg or 150 mg).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: 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
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: 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
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Adiponectin at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
measure: Change From Baseline in Leptin at Week 4, 12, 24 and 52
timeFrame: Baseline, Week 4, 12, 24 and 52
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Homburg
country: Germany
facility: Novartis Investigative Site
city: Langenau
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: