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

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

Sponsors

Lead Sponsor: Novartis Pharmaceuticals

Source Novartis
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.

Overall Status Completed
Start Date February 10, 2016
Completion Date February 19, 2018
Primary Completion Date April 26, 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Aortic Vascular Inflammation as Measured by FDG-PET/CT baseline, 12 weeks
Secondary Outcome
Measure Time Frame
Change in Adiponectin Total baseline, 12 weeks
Change in Apolipoprotein B baseline, 12 weeks
Change in CRP baseline, 12 weeks
Change in Cholesterol baseline, 12 weeks
Change in Fetuin A baseline, 12 weeks
Change in Ferritin baseline, 12 weeks
Change in GlycA baseline, 12 weeks
Change in HDL Cholesterol baseline, 12 weeks
Change in HDL Function (Cholesterol Efflux) baseline, 12 weeks
HDL Particle Total baseline, 12 weeks
HDL Size baseline, 12 weeks
HOMA-IR baseline, 12 weeks
Change in IL-2 Receptor A baseline, 12 weeks
Change in IL-18 baseline, 12 weeks
Change in IL-6 baseline, 12 weeks
Change in Intermediate-Density Lipoprotein (IDL) Particle baseline, 12 weeks
Change LDL Cholesterol baseline, 12 weeks
Change in Leptin baseline, 12 weeks
LDL Particle Total baseline, 12 weeks
LDL Size baseline, 12 weeks
Change in Triglycerides baseline, 12 weeks
Change in TNF-α baseline, 12 weeks
Change VLDL Particle Total baseline, 12 weeks
VLDL Size baseline, 12 weeks
Area and Severity Index 75 (PASI 75) week 12
Psoriasis Area and Severity Index 90 (PASI 90) week 12
Psoriasis Area and Severity Index 100 (PASI100) week 12
Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1 week 12
Dermatology Life Quality Index (DLQI) Total Score baseline, 12 weeks
Enrollment 91
Condition
Intervention

Intervention Type: Drug

Intervention Name: Secukinumab 300 mg

Description: 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.

Arm Group Label: Secukinumab

Other Name: AIN457 300 mg

Intervention Type: Biological

Intervention Name: Placebo

Description: 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.

Arm Group Label: Placebo then Secukinumab

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Novartis Investigative Site | Los Angeles, California, 90033, United States
Novartis Investigative Site | Santa Ana, California, 92701, United States
Novartis Investigative Site | Rockville, Maryland, 20850, United States
Novartis Investigative Site | Saint Louis, Missouri, 63117, United States
Novartis Investigative Site | Buffalo, New York, 14221, United States
Novartis Investigative Site | New York, New York, 10025 1737, United States
Novartis Investigative Site | Portland, Oregon, 97223, United States
Novartis Investigative Site | Portland, Oregon, 97239, United States
Novartis Investigative Site | Exton, Pennsylvania, 19341, United States
Novartis Investigative Site | Dallas, Texas, 75246-1613, United States
Novartis Investigative Site | Houston, Texas, 77004, United States
Novartis Investigative Site | Salt Lake City, Utah, 84132, United States
Location Countries

United States

Verification Date

July 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Secukinumab

Type: Experimental

Description: 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

Label: Placebo then Secukinumab

Type: Placebo Comparator

Description: 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.

Acronym VIP-S
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov