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

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ClinicalTrials.gov Identifier: NCT02690701
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Biological: Secukinumab 300 mg Biological: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 10, 2016
Actual Primary Completion Date : April 26, 2017
Actual Study Completion Date : February 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: 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
Biological: Secukinumab 300 mg

Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist 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) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits.

The injections not occurring on days of study visits will be done by the patients (or caregivers) at home.

Other Name: AIN457 300 mg

Placebo Comparator: Placebo

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
Placebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist 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 will be 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) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring on days of study visits will be done by the patients (or caregivers) at home.




Primary Outcome Measures :
  1. Aortic vascular inflammation as measured by FDG-PET/CT [ Time Frame: baseline, 12 weeks ]
    Change from baseline in the target to background ratio from the aorta


Secondary Outcome Measures :
  1. Biomarkers [ Time Frame: baseline, 12 weeks ]
    Change from baseline in inflammatory, metabolic and lipid biomarker levels

  2. Psoriasis Area and Severity Index 75 (PASI 75) [ Time Frame: baseline, 12 weeks ]
    PASI 75 response (yes, no)

  3. Psoriasis Area and Severity Index 90 (PASI 90) [ Time Frame: baseline, 12 weeks ]
    PASI 90 response (yes, no)

  4. Psoriasis Area and Severity Index 100 (PASI 100) [ Time Frame: baseline, 12 weeks ]
    PASI 100 response (yes, no)

  5. Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 [ Time Frame: baseline, 12 weeks ]
    IGA mod 2011 score of 0 or 1 (yes, no)

  6. Dermatology Life Quality Index (DLQI) total score [ Time Frame: baseline, 12 weeks ]
    Change from baseline in the DLQI total score

  7. Number of patients with Adverse Events, Serious Adverse Events or Death [ Time Frame: 52 weeks ]
    Assessment of safety and tolerability of secukinumab by vital signs, labs, and adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690701


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02690701     History of Changes
Other Study ID Numbers: CAIN457AUS02
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
psoriasis
plaque psoriasis
secukinumab
AIN457
biologic
monoclonal antibody
aortic vascular inflammation

Additional relevant MeSH terms:
Inflammation
Psoriasis
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs