Chronic Plaque PsoriasisPhase 4VIP-SNCT02690701

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

A Phase 4 study testing Secukinumab 300 mg in people with Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Plaque Psoriasis
What is being tested?: Secukinumab 300 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 12 sitesUnited States
Study dates: 10 Feb 2016to 19 Feb 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

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

Other trials in United States

About this study

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

Conditions: Chronic Plaque Psoriasis
Being tested: Secukinumab 300 mg, Placebo
Keywords: psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, aortic vascular inflammation
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Secukinumab 300 mgDrug
Also called AIN457 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.
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.

Study groups in NCT02690701
Study group	Role	What they receive
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 Receives: 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. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: baseline, 12 weeks

Secondary outcomes (29)

Change in Adiponectin Total
Change from baseline in Adiponectin to measure adiposity
Measured: baseline, 12 weeks
Change in Apolipoprotein B
Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes
Measured: baseline, 12 weeks
Change in CRP
Change from baseline in C reactive protein (CRP), a measure of inflammation
Measured: baseline, 12 weeks
Change in Cholesterol
Change from baseline in Cholesterol level
Measured: baseline, 12 weeks
Change in Fetuin A
Change from baseline in Fetuin A, a marker predictive of diabetes
Measured: baseline, 12 weeks
Change in Ferritin
Change from baseline in Ferritin, a marker predictive of diabetes
Measured: baseline, 12 weeks
Change in GlycA
Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation
Measured: baseline, 12 weeks
Change in HDL Cholesterol
Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker
Measured: baseline, 12 weeks
Change in HDL Function (Cholesterol Efflux)
Change from baseline in High Density Lipoprotein (HDL) Cholesterol (cholesterol efflux) , a cardiometabolic biomarker
Ratio of the pleated serum to removal of Cholesterol
Measured: baseline, 12 weeks
HDL Particle Total
Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total
Measured: baseline, 12 weeks
HDL Size
Change from baseline in High Density Lipoprotein (HDL) Cholesterol size
Measured: baseline, 12 weeks
HOMA-IR
Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin [uIU/mL (mU/L)] x Glucose (mg/dL) = HOMA-IR
Measured: baseline, 12 weeks
Change in IL-2 Receptor A
Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes
Measured: baseline, 12 weeks
Change in IL-18
Interleukin-18 (IL-18) is a marker predictive of diabetes
Measured: baseline, 12 weeks
Change in IL-6
Interleukin 6 (IL-6) is a marker of inflammation
Measured: baseline, 12 weeks
Change in Intermediate-Density Lipoprotein (IDL) Particle
Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function
Measured: baseline, 12 weeks
Change LDL Cholesterol
Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function
Measured: baseline, 12 weeks
Change in Leptin
Change from baseline in Leptin a marker of adiposity
Measured: baseline, 12 weeks
LDL Particle Total
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total
Measured: baseline, 12 weeks
LDL Size
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size
Measured: baseline, 12 weeks
Change in Triglycerides
Triglycerides are a marker of cardiometabolic function
Measured: baseline, 12 weeks
Change in TNF-α
Change in Tumor necrosis factor (TNF, tumor necrosis factor alpha, TNFα is a marker of inflammation Also written as TNF-alpha
Measured: baseline, 12 weeks
Change VLDL Particle Total
Change in Very-low-density lipoprotein (VLDL) cholesterol level
Measured: baseline, 12 weeks
VLDL Size
Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size
Measured: baseline, 12 weeks
Area and Severity Index 75 (PASI 75)
Percentage of participants with PASI75 response (yes, no) PASI75 response = at least a 75% improvement (reduction) in PASI score compared to baseline
Psoriasis Area and Severity Index ( PASI) is a tool for measuring the severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Measured: week 12
Psoriasis Area and Severity Index 90 (PASI 90)
Percentage of participants with PASI90 response (yes, no) PASI90 response = at least a 90\& improvement (reduction) in PASI score compared to baseline
Measured: week 12
Psoriasis Area and Severity Index 100 (PASI100)
Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis
Measured: week 12
Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1
percentage of participants with IGA mod 2011 score of 0 or 1 (yes, no)
Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1
Statistical analysis (Cochran-Mantel-Haenszel test) of Novartis Investigator's Global Assessment Modified 2011 0 or 1 response by visit (Non-responder Imputation)
Measured: week 12
Dermatology Life Quality Index (DLQI) Total Score
Change from baseline in the DLQI total score
Summary of analysis of change from baseline in DLQI at Week 12 and statistical analysis (using Analysis of Covariance) of change from baseline in DLQI at Week 12
The higher the score, the more quality of life is impaired.
0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life
Measured: baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 201619 Feb 2018

First posted24 Feb 2016 (estimated)
Study start10 Feb 2016
Primary completion26 Apr 2017
Study completion19 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02690701
Sponsor's protocol ID: CAIN457AUS02
Acronym: VIP-S
Status last verified: Jul 2019
First submitted: 19 Feb 2016
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: 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

Publications

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.
PubMed 32088207

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02690701
Acronym / sponsor ID: VIP-S / CAIN457AUS02
Conditions: Chronic Plaque Psoriasis
Keywords: psoriasis, plaque psoriasis, secukinumab, AIN457, biologic, monoclonal antibody, aortic vascular inflammation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 10 Feb 2016 (actual)
Primary completion: 26 Apr 2017 (actual)
Study completion: 19 Feb 2018 (actual)
First posted: 24 Feb 2016 (estimated)
Results: Posted 9 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Secukinumab	Experimental	Drug: Secukinumab 300 mgEligible 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
Placebo then Secukinumab	Placebo comparator	Biological: PlaceboEligible 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Secukinumab 300 mgAlso: AIN457 300 mgSecukinumab 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.	Drug	Secukinumab
PlaceboPlacebo 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.	Biological	Placebo then Secukinumab

Primary outcome

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 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)

29 secondary outcomes

Change in Adiponectin Total
Time frame: baseline, 12 weeks
Change in Apolipoprotein B
Time frame: baseline, 12 weeks
Change in CRP
Time frame: baseline, 12 weeks
Change in Cholesterol
Time frame: baseline, 12 weeks
Change in Fetuin A
Time frame: baseline, 12 weeks
Change in Ferritin
Time frame: baseline, 12 weeks
Change in GlycA
Time frame: baseline, 12 weeks
Change in HDL Cholesterol
Time frame: baseline, 12 weeks
Change in HDL Function (Cholesterol Efflux)
Time frame: baseline, 12 weeks
HDL Particle Total
Time frame: baseline, 12 weeks
HDL Size
Time frame: baseline, 12 weeks
HOMA-IR
Time frame: baseline, 12 weeks
Change in IL-2 Receptor A
Time frame: baseline, 12 weeks
Change in IL-18
Time frame: baseline, 12 weeks
Change in IL-6
Time frame: baseline, 12 weeks
Change in Intermediate-Density Lipoprotein (IDL) Particle
Time frame: baseline, 12 weeks
Change LDL Cholesterol
Time frame: baseline, 12 weeks
Change in Leptin
Time frame: baseline, 12 weeks
LDL Particle Total
Time frame: baseline, 12 weeks
LDL Size
Time frame: baseline, 12 weeks
Change in Triglycerides
Time frame: baseline, 12 weeks
Change in TNF-α
Time frame: baseline, 12 weeks
Change VLDL Particle Total
Time frame: baseline, 12 weeks
VLDL Size
Time frame: baseline, 12 weeks
Area and Severity Index 75 (PASI 75)
Time frame: week 12
Psoriasis Area and Severity Index 90 (PASI 90)
Time frame: week 12
Psoriasis Area and Severity Index 100 (PASI100)
Time frame: week 12
Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1
Time frame: week 12
Dermatology Life Quality Index (DLQI) Total Score
Time frame: baseline, 12 weeks

Results and safety

Results posted to the registry on 9 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Secukinumab	46	44
Placebo	45	42

Primary outcome: Aortic Vascular Inflammation as Measured by FDG-PET/CT

Time frame: baseline, 12 weeks. Mean (Standard Deviation). Unit: target to background ratio (TBR)

Measure	Secukinumab n = 46	Placebo n = 45
Baseline	1.6615 (0.37380)	1.6333 (0.33228)
Change from Baseline at Week 12	0.0143 (0.25520)	0.0655 (0.28086)

Secukinumab vs Placebo: Least Square Mean: -0.053 (95% CI -0.169 to 0.064), p = 0.3712, ANCOVA

Population analysed: Full Analysis Set (FAS) included all participants assigned medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from this analysis set. Following intent-to-treat principle, participants were analyzed according to treatment they were assigned to at randomization

29 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 48 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Secukinumab 300 mg	5 of 46 (10.9%)	21 of 46 (45.7%)	0 of 46
Placebo/Secukinumab 300 mg	0 of 45 (0%)	18 of 45 (40%)	0 of 45
Total	5 of 91 (5.5%)	39 of 91 (42.9%)	0 of 91

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32088207Gelfand 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.
A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. 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

Related trials for Chronic Plaque Psoriasis

Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
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RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Secukinumab 300 mg in people with Chronic Plaque Psoriasis, run by Novartis Pharmaceuticals at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aortic Vascular Inflammation as Measured by FDG-PET/CT (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02690701, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.