Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab

NCT ID: NCT02559622

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

300 mg secukinumab

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

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

300 mg secukinumab

150 mg secukinumab

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

Group Type: EXPERIMENTAL

Secukinumab

Intervention Type: DRUG

150 mg secukinumab

Placebo followed by 300 mg secukinumab

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)

Group Type: OTHER

Placebo

Intervention Type: OTHER

Placebo followed by 300 mg secukinumab

Placebo followed by 150 mg secukinumab

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)

Group Type: OTHER

Placebo

Intervention Type: OTHER

Placebo followed by 150 mg secukinumab

Interventions

Secukinumab

300 mg secukinumab

Intervention Type: DRUG

Placebo

Placebo followed by 300 mg secukinumab

Intervention Type: OTHER

Placebo

Placebo followed by 150 mg secukinumab

Intervention Type: OTHER

Secukinumab

150 mg secukinumab

Intervention Type: DRUG

Other Intervention Names

AIN457; AIN457

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Augsburg, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bielefeld, , Germany

Novartis Investigative Site

Bochum, , Germany

Novartis Investigative Site

Bonn, , Germany

Novartis Investigative Site

Darmstadt, , Germany

Novartis Investigative Site

Dresden, , Germany

Novartis Investigative Site

Duisburg, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Novartis Investigative Site

Gera, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Heidelberg, , Germany

Novartis Investigative Site

Homburg, , Germany

Novartis Investigative Site

Langenau, , Germany

Novartis Investigative Site

Lübeck, , Germany

Novartis Investigative Site

Mainz, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Münster, , Germany

Novartis Investigative Site

Stade, , Germany

Novartis Investigative Site

Ulm, , Germany

Countries

Germany

Other Identifiers

CAIN457ADE02

Identifier Type: -

Identifier Source: org_study_id