Clinical trial NCT02690701: Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers After 12 Weeks of Treatment, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Plaque Psoriasis
Keywords: psoriasis
plaque psoriasis
secukinumab
AIN457
biologic
monoclonal antibody
aortic vascular inflammation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-02-24
Enrollment: 91
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: 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.


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

Primary outcomes:
measure: Aortic Vascular Inflammation as Measured by FDG-PET/CT
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change in Adiponectin Total
timeFrame: baseline, 12 weeks
measure: Change in Apolipoprotein B
timeFrame: baseline, 12 weeks
measure: Change in CRP
timeFrame: baseline, 12 weeks
measure: Change in Cholesterol
timeFrame: baseline, 12 weeks
measure: Change in Fetuin A
timeFrame: baseline, 12 weeks
measure: Change in Ferritin
timeFrame: baseline, 12 weeks
measure: Change in GlycA
timeFrame: baseline, 12 weeks
measure: Change in HDL Cholesterol
timeFrame: baseline, 12 weeks
measure: Change in HDL Function (Cholesterol Efflux)
timeFrame: baseline, 12 weeks
measure: HDL Particle Total
timeFrame: baseline, 12 weeks
measure: HDL Size
timeFrame: baseline, 12 weeks
measure: HOMA-IR
timeFrame: baseline, 12 weeks
measure: Change in IL-2 Receptor A
timeFrame: baseline, 12 weeks
measure: Change in IL-18
timeFrame: baseline, 12 weeks
measure: Change in IL-6
timeFrame: baseline, 12 weeks
measure: Change in Intermediate-Density Lipoprotein (IDL) Particle
timeFrame: baseline, 12 weeks
measure: Change LDL Cholesterol
timeFrame: baseline, 12 weeks
measure: Change in Leptin
timeFrame: baseline, 12 weeks
measure: LDL Particle Total
timeFrame: baseline, 12 weeks
measure: LDL Size
timeFrame: baseline, 12 weeks
measure: Change in Triglycerides
timeFrame: baseline, 12 weeks
measure: Change in TNF-α
timeFrame: baseline, 12 weeks
measure: Change VLDL Particle Total
timeFrame: baseline, 12 weeks
measure: VLDL Size
timeFrame: baseline, 12 weeks
measure: Area and Severity Index 75 (PASI 75)
timeFrame: week 12
measure: Psoriasis Area and Severity Index 90 (PASI 90)
timeFrame: week 12
measure: Psoriasis Area and Severity Index 100 (PASI100)
timeFrame: week 12
measure: Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1
timeFrame: week 12
measure: Dermatology Life Quality Index (DLQI) Total Score
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Santa Ana
country: United States
facility: Novartis Investigative Site
state: California
city: Rockville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Exton
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
Study officials:
References:
citation: Gelfand JM, Shin DB, Duffin KC, Armstrong AW, Blauvelt A, Tyring SK, Menter A, Gottlieb S, Lockshin BN, Simpson EL, Kianifard F, Sarkar RP, Muscianisi E, Steadman J, Ahlman MA, Playford MP, Joshi AA, Dey AK, Werner TJ, Alavi A, Mehta NN. A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S). J Invest Dermatol. 2020 Sep;140(9):1784-1793.e2. doi: 10.1016/j.jid.2020.01.025. Epub 2020 Feb 21.