Study in patients with moderate to severe plaque psoriasis and metabolic syndrome to assess the efficacy and safety of Cosentyx plus lifestyle intervention compared to Cosentyx therapy alone

Phase 1

• Conditions: Moderate to severe plaque type psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-001671-79-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-23
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Men or women of at least 18 years of age at the time of screening.
3. Patients with moderate to severe plaque-type psoriasis who are candidates for systemic therapy.
4. Fulfillment of metabolic syndrome diagnosis criteria at screening visit.
5. Willingness and motivation to actively participate in the lifestyle intervention, which means patients need to be willing to increase physical activity and to change dietary habits in order to achieve weight loss.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 680
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening.
2. Previous exposure to Secukinumab or any other biologic drug directly targeting IL17A or the IL17A receptor (e.g. Brodalumab, Ixekizumab).
3. History of hypersensitivity to Secukinumab, trehalose-dihydrate, L-histidine, L-histidinhydrochloride-monohydrate, L-methionine, polysorbate 80, water for injection, or to substances of similar chemical classes.
4. Diagnosis of type 1 diabetes.
5. Significant, progressive or uncontrolled medical problems at baseline which according to the opinion of the Investigator render the subject unsuitable for the trial - also in regard to participation in the lifestyle intervention - or put the subject at increased risk when participating in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified