NCT02690701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 9, 2019

Completed
Last Updated

January 5, 2021

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

February 19, 2016

Results QC Date

February 19, 2019

Last Update Submit

December 9, 2020

Conditions

Chronic Plaque Psoriasis

Keywords

psoriasisplaque psoriasissecukinumabAIN457biologicmonoclonal antibodyaortic vascular inflammation

Outcome Measures

Primary Outcomes (1)

  • Aortic Vascular Inflammation as Measured by FDG-PET/CT

    Change from baseline in the target to background ratio from the whole aorta. Effect of secukinumab 300 mg subcutaneous (sc) compared to placebo on aortic vascular inflammation with respect to the change from baseline in the target (arterial vascular uptake) to background (venous blood pool) ratio from the aorta. The primary analysis time point was at Week 12. Increased aortic vascular inflammation as measured by (18F) fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT)

    baseline, 12 weeks

Secondary Outcomes (29)

  • 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

  • +24 more secondary outcomes

Study Arms (2)

Secukinumab

EXPERIMENTAL

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

Drug: Secukinumab 300 mg

Placebo then Secukinumab

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

Secukinumab 300 mgDRUG

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.

Also known as: AIN457 300 mg
Secukinumab
PlaceboBIOLOGICAL

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.

Placebo then Secukinumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Males and females at least 18 years of age with moderate to severe plaque psoriasis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Novartis Investigative Site

Los Angeles, California, 90033, United States

Location

Novartis Investigative Site

Santa Ana, California, 92701, United States

Location

Novartis Investigative Site

Rockville, Maryland, 20850, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63117, United States

Location

Novartis Investigative Site

Buffalo, New York, 14221, United States

Location

Novartis Investigative Site

New York, New York, 10025 1737, United States

Location

Novartis Investigative Site

Portland, Oregon, 97223, United States

Location

Novartis Investigative Site

Portland, Oregon, 97239, United States

Location

Novartis Investigative Site

Exton, Pennsylvania, 19341, United States

Location

Novartis Investigative Site

Dallas, Texas, 75246-1613, United States

Location

Novartis Investigative Site

Houston, Texas, 77004, United States

Location

Novartis Investigative Site

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • 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.

    PMID: 32088207DERIVED

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
+1 (800) 778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2016

First Posted

February 24, 2016

Study Start

February 10, 2016

Primary Completion

April 26, 2017

Study Completion

February 19, 2018

Last Updated

January 5, 2021

Results First Posted

July 9, 2019

Record last verified: 2019-07

Locations

US(12)