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

A randomized, multicenter 28 week study to compare the efficacy and safety of combining Cosentyx (Secukinumab) (4-weekly, 300 mg s.c.) with a lifestyle intervention to Cosentyx therapy alone in adult patients with moderate to severe plaque-type psoriasis and concomitant metabolic syndrome, followed by a 28 week extension period - METABOLYX

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001671-79-DE

Enrollment

760

Registered

2017-11-23

Start date

2018-02-15

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe plaque type psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Current

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the combination of Secukinumab with lifestyle intervention results in higher psoriasis treatment efficacy compared to Secukinumab alone in psoriasis patients with concomitant metabolic syndrome.;Secondary Objective: - To explore treatment efficacy of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on systemic inflammation. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on glucose metabolism. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on lipid metabolism. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on body weight. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on systolic and diastolic blood pressure. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on health-related quality of life and mental well-being.;Primary end point(s): Percentage of patients achieving PASI90 at week 28 in both randomized treatment arms, Secukinumab alone and Secukinumab combined with lifestyle intervention;Timepoint(s) of evaluation of this end point: At week 28	—

Measure

Time frame

Main Objective: To demonstrate that the combination of Secukinumab with lifestyle intervention results in higher psoriasis treatment efficacy compared to Secukinumab alone in psoriasis patients with concomitant metabolic syndrome.;Secondary Objective: - To explore treatment efficacy of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on systemic inflammation. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on glucose metabolism. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on lipid metabolism. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on body weight. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on systolic and diastolic blood pressure. - To evaluate the effect of Secukinumab combined with lifestyle intervention in comparison to Secukinumab alone on health-related quality of life and mental well-being.;Primary end point(s): Percentage of patients achieving PASI90 at week 28 in both randomized treatment arms, Secukinumab alone and Secukinumab combined with lifestyle intervention;Timepoint(s) of evaluation of this end point: At week 28

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Secondary

Measure	Time frame
Secondary end point(s): - PASI75, 90 and 100 as well as absolute PASI scores in both treatment arms at week 1, 2, 3, 4, 8, 12, 16, 20, 24 and 28 - hsCRP in both treatment arms throughout the duration of the core study - HbA1c, fructosamine and fasting plasma glucose in both treatment arms throughout the duration of the core study - Total cholesterol, LDL, HDL and triglycerides in both treatment arms throughout the duration of the core study - Waist circumference, body weight and BMI in both treatment arms throughout the duration of the core study - Systolic and diastolic blood pressure in both treatment arms throughout the duration of the core study - Absolute DLQI, relative change of DLQI, proportion of patients withDLQI 0/1, absolute WHO-5, relative change in WHO-5, absolute self-assessed itch, pain, scaling, relative change in self-assessed itch, pain, scaling in both treatment arms throughout the duration of the core study;Timepoint(s) of evaluation of this end point: See E.5.2	—

Measure

Time frame

Secondary end point(s): - PASI75, 90 and 100 as well as absolute PASI scores in both treatment arms at week 1, 2, 3, 4, 8, 12, 16, 20, 24 and 28 - hsCRP in both treatment arms throughout the duration of the core study - HbA1c, fructosamine and fasting plasma glucose in both treatment arms throughout the duration of the core study - Total cholesterol, LDL, HDL and triglycerides in both treatment arms throughout the duration of the core study - Waist circumference, body weight and BMI in both treatment arms throughout the duration of the core study - Systolic and diastolic blood pressure in both treatment arms throughout the duration of the core study - Absolute DLQI, relative change of DLQI, proportion of patients withDLQI 0/1, absolute WHO-5, relative change in WHO-5, absolute self-assessed itch, pain, scaling, relative change in self-assessed itch, pain, scaling in both treatment arms throughout the duration of the core study;Timepoint(s) of evaluation of this end point: See E.5.2

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Countries

Germany

Contacts

Public ContactMedizinischer Infoservice

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026