Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab

NCT02559622 | Completed Phase 3 Results

• 1 other identifier: CAIN457ADE02
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 23

Brief Summary

The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers were assessed to evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging (MRI) was performed in a sub-population to assess the treatment effect on arterial vessel wall morphometry in atherosclerosis prone vascular beds.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment

  Flow Mediated Dilation (FMD) is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100\*\[(D maximum - D baseline) / D baseline\]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 millimeter of mercury (mmHg) for 4.5 minutes and for 4.5 minutes following deflation.

  Week 12

Secondary Outcomes (17)

• Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52

  Baseline, Week 4, 12, 24 and 52

• Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52

  Baseline, Week 4, 12, 24 and 52

• Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52

  Baseline, Week 4, 12, 24 and 52

• Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12

  Baseline, Week 12

• Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52

  Baseline, Week 52

Study Arms (4)

300 mg secukinumab

EXPERIMENTAL

300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection)

Drug: Secukinumab

150 mg secukinumab

EXPERIMENTAL

150 mg secukinumab every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection)

Drug: Secukinumab

Placebo followed by 300 mg secukinumab

OTHER

Placebo until week 12 followed by 300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection)

Other: Placebo

Placebo followed by 150 mg secukinumab

OTHER

Placebo until week 12 followed by 150 mg secukinumab every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection)

Other: Placebo

Interventions

Secukinumab DRUG

300 mg secukinumab

Also known as: AIN457

300 mg secukinumab

Placebo OTHER

Placebo followed by 300 mg secukinumab

Placebo followed by 300 mg secukinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization with a Psoriasis Area and Severity Index (PASI) score ≥ 10 at randomization.
• Inadequate response, intolerance or contraindication to cyclosporine, methotrexate and psoralen plus ultraviolet A light treatment (PUVA) as documented in the patient's medical history or reported by the patient or determined by the investigator at screening. Relative contraindications such as interference of patient's lifestyle with the treatment are accepted.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttata psoriasis) at screening or randomization.
• Ongoing use of prohibited psoriasis and non-psoriasis treatments.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (23)

Novartis Investigative Site

Augsburg, 86179, Germany

Location

Novartis Investigative Site

Berlin, 10789, Germany

Location

Novartis Investigative Site

Berlin, 13187, Germany

Location

Novartis Investigative Site

Bielefeld, 33647, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Darmstadt, 64283, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Duisburg, 47166, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79104, Germany

Location

Novartis Investigative Site

Gera, 07548, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Homburg, 66421, Germany

Location

Novartis Investigative Site

Langenau, 89129, Germany

Location

Novartis Investigative Site

Lübeck, 23538, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Stade, 21682, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862--778--8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: August 4, 2015
• First Posted: September 24, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 13, 2017
• Results First Posted: July 13, 2017

Record last verified: 2017-04

Locations

DE (23)