Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis

PHASE4CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

February 10, 2016

Primary Completion Date

April 26, 2017

Study Completion Date

February 19, 2018

Conditions
Chronic Plaque Psoriasis
Interventions
DRUG

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."

BIOLOGICAL

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."

Trial Locations (12)

14221

Novartis Investigative Site, Buffalo

19341

Novartis Investigative Site, Exton

20850

Novartis Investigative Site, Rockville

63117

Novartis Investigative Site, St Louis

77004

Novartis Investigative Site, Houston

84132

Novartis Investigative Site, Salt Lake City

90033

Novartis Investigative Site, Los Angeles

92701

Novartis Investigative Site, Santa Ana

97223

Novartis Investigative Site, Portland

97239

Novartis Investigative Site, Portland

10025 1737

Novartis Investigative Site, New York

75246-1613

Novartis Investigative Site, Dallas

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY