Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
NCT ID: NCT02690701
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2016-02-10
2018-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Secukinumab
Eligible patients received secukinumab 300 mg once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by monthly dosing starting at Week 8 through Week 48 inclusive
Secukinumab 300 mg
Secukinumab 300 mg was provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab consisted of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 48 inclusive.
The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occurred on days of study visits.
The injections not occurring on days of study visits were done by the patients (or caregivers) at home.
Placebo then Secukinumab
Eligible patients received placebo doses once weekly at Baseline, Weeks 1, 2, 3 and 4 followed by a dose after four weeks at Week 8.
Beginning with the Week 12 dose, participants were switched to treatment with secukinumab 300 mg and were dosed once weekly at Weeks 12, 13, 14, 15 and 16 followed by monthly dosing through Week 48 inclusive.
Placebo
Placebo was provided in 1 mL prefilled syringe. Each placebo dose consisted of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3, 4), then after four weeks at Week 8. At Week 12, patients were switched to receive 300 mg secukinumab once weekly for five weeks (Weeks 12, 13, 14, 15, 16) followed by monthly dosing through Week 48 inclusive.
The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occured on days of study visits.
The injections not occurring on days of study visits were done by the patients (or caregivers) at home.
Interventions
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Secukinumab 300 mg
Secukinumab 300 mg was provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab consisted of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 48 inclusive.
The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occurred on days of study visits.
The injections not occurring on days of study visits were done by the patients (or caregivers) at home.
Placebo
Placebo was provided in 1 mL prefilled syringe. Each placebo dose consisted of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3, 4), then after four weeks at Week 8. At Week 12, patients were switched to receive 300 mg secukinumab once weekly for five weeks (Weeks 12, 13, 14, 15, 16) followed by monthly dosing through Week 48 inclusive.
The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occured on days of study visits.
The injections not occurring on days of study visits were done by the patients (or caregivers) at home.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Santa Ana, California, United States
Novartis Investigative Site
Rockville, Maryland, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Buffalo, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Exton, Pennsylvania, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
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CAIN457AUS02
Identifier Type: -
Identifier Source: org_study_id
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