Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02559622
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — DRUG
    300 mg secukinumab
  • Placebo — OTHER
    Placebo followed by 300 mg secukinumab
  • Placebo — OTHER
    Placebo followed by 150 mg secukinumab
  • Secukinumab — DRUG
    150 mg secukinumab

Study Details

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.

Key Dates

Start date
Apr 30, 2014
Status verified
Apr 2017
Primary completion
Apr 30, 2016
Completion
Apr 30, 2016

Study Design

Enrollment
151 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 300 mg secukinumab
    300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection)
  • Experimental: 150 mg secukinumab
    150 mg secukinumab every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection)
  • Other: Placebo followed by 300 mg secukinumab
    Placebo until week 12 followed by 300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection)
  • Other: Placebo followed by 150 mg secukinumab
    Placebo until week 12 followed by 150 mg secukinumab every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection)

Primary Outcome Measure

Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment [ Time Frame: Week 12 ]

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