Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome

NCT03440736 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CAIN457ADE082016-001671-79
• Study Type: interventional
• Target: 781
• Locations: 1 country
• Sites: 75

Brief Summary

This study was a randomized, open-label, parallel-group, active comparator controlled study with two treatment arms designed to answer the question whether the combination of Secukinumab with lifestyle intervention could primarily improve skin symptoms and secondly cardiometabolic status more than Secukinumab alone in psoriasis patients with concomitant metabolic syndrome by targeting the shared pathophysiology behind both diseases, which is systemic inflammation.

Conditions

Psoriasis; Metabolic Syndrome

Keywords

Psoriasis; Metabolic syndrome; Diabetes; Obesity; Life-style; Life-style intervention; Secukinumab; CAIN457A; CAIN457ADE08; AIN457A; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing psoriasis; remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 at Week 28

  The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 represents patients achieving \>= 90% improvement (reduction) in PASI score compared to Baseline. Patients with missing PASI at Week 28 were counted as non-responders.

  Baseline, Week 28

Secondary Outcomes (24)

• Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

• Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

• Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

• Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

• Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Study Arms (2)

Secukinumab 300 mg subcutaneous (s.c.)

ACTIVE COMPARATOR

Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).

Drug: Secukinumab

Secukinumab 300 mg subcutaneous (s.c.) and lifestyle intervention

EXPERIMENTAL

Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.

Drug: Secukinumab; Behavioral: Life-style intervention

Interventions

Secukinumab DRUG

Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24)

Secukinumab 300 mg subcutaneous (s.c.); Secukinumab 300 mg subcutaneous (s.c.) and lifestyle intervention

Life-style intervention BEHAVIORAL

A structured program to guide weight loss and increased physical activity

Secukinumab 300 mg subcutaneous (s.c.) and lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed.
• Men or women of at least 18 years of age at the time of screening.
• Patients must be able to understand and communicate with the investigator and must be willing and able to comply with all study procedures.
• Patients with moderate to severe plaque-type psoriasis who are candidates for systemic therapy, diagnosed at least 6 month before randomization and baseline value of
• PASI \> 10 and
• DLQI \> 10 and
• Body Surface Area (BSA) affected by plaque-type psoriasis ≥ 10%
• Fulfillment of Metabolic Syndrome definition (Alberti et al., 2009), which means fulfillment of ≥3 of the following criteria at screening visit:
• Fasting (8 hours) plasma glucose ≥ 100 mg/dl or ongoing antidiabetic drug treatment (defined as: metformin, DPP4 inhibitors, GLP1 analogues, SGLT2 inhibitors)
• Abdominal obesity defined by elevated waist circumference (measured as defined in section 6.4.5): Male: ≥94 cm, female: ≥80 cm (except for patients of Asian, South or Central American ethnicity, for whom the cut off values are: Male: ≥90 cm, female: ≥80 cm)
• Fasting (8 hours) triglycerides ≥ 150 mg/dl or ongoing drug treatment for elevated triglycerides (defined as: fibrates or nicotinic acid).
• Fasting (8 hours) HDL-C \< 40 mg/dl in men or \< 50 mg/dl in women or ongoing drug treatment for reduced HDL-C (defined as: fibrates, nicotinic acid or statins).
• Resting blood pressure: Systolic blood pressure ≥ 130 and/ or diastolic blood pressure ≥ 85 mmHg (measured as defined in section 6.4.6) or ongoing antihypertensive drug treatment \[defined as: ACE inhibitors, beta blockers, angiotensin receptor antagonists (e.g. Valsartan), aldosterone receptor antagonists, diuretics, nitrates, calcium channel blockers (e.g. Verapamil, Nifedipin), Aliskiren, Clonidin, alpha1 receptor antagonists (e.g. Doxazosin), Dihydralazin, Minoxidil, Moxonidin or Methyldopa\].
• Willingness and motivation to actively participate in a lifestyle intervention, which means patients need to be willing to increase physical activity and to change dietary habits.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g. pustular, erythrodermic and guttate psoriasis) at screening.
• Previous exposure to Secukinumab or any other biologic drug directly targeting IL17A or the IL17A receptor (e.g. Brodalumab, Ixekizumab).
• Exposure to anti-TNF treatment during 1 year prior to baseline.
• Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at screening.
• 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.
• History of latex hypersensitivity.
• Ongoing participation (including safety follow-up period) in other interventional or non-interventional studies in any dermatological indication
• Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to (Table 5-1). Note: Administration of live vaccines 6 weeks prior to baseline (visit 2) or during the study period is also prohibited.
• Diagnosis of type 1 diabetes.
• Patients with diagnosed type 2 diabetes, if they fulfill one or more of the following conditions:
• uncontrolled type 2 diabetes, meaning HbA1c \> 8.0%,
• pharmacological therapy with one or more of the following agents: Insulin, sulfonylurea agents/analogues, thiazolidinediones/glitazones
• Insufficiently controlled, severe arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 95 mmHg) with urgent need for therapy initiation or foreseeable need for medication change during the duration of the core study.
• Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (75)

Novartis Investigative Site

Langenau, Baden-Wurttemberg, 89129, Germany

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Novartis Investigative Site

Munich, Bavaria, 80469, Germany

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Novartis Investigative Site

Munich, Bavaria, 81377, Germany

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Novartis Investigative Site

Darmstadt, Hesse, 64283, Germany

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Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany

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Novartis Investigative Site

Bramsche, Lower Saxony, 49565, Germany

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Novartis Investigative Site

Göttingen, Lower Saxony, 37075, Germany

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Novartis Investigative Site

Lingen Ems, Lower Saxony, 49809, Germany

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Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

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Novartis Investigative Site

Detmold, North Rhine-Westphalia, 32756, Germany

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Novartis Investigative Site

Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Novartis Investigative Site

Dresden, Saxony, 01307, Germany

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Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

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Novartis Investigative Site

Leipzig, Saxony, 04207, Germany

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Novartis Investigative Site

Halle, Saxony-Anhalt, 06108, Germany

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Novartis Investigative Site

Andernach, 56626, Germany

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Novartis Investigative Site

Augsburg, 86179, Germany

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Novartis Investigative Site

Bad Soden, 65812, Germany

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Novartis Investigative Site

Berlin, 10117, Germany

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Novartis Investigative Site

Berlin, 10783, Germany

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Novartis Investigative Site

Berlin, 10789, Germany

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Novartis Investigative Site

Berlin, 13055, Germany

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Novartis Investigative Site

Berlin, 13088, Germany

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Novartis Investigative Site

Berlin, 13125, Germany

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Novartis Investigative Site

Berlin, 13187, Germany

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Novartis Investigative Site

Berlin, 13353, Germany

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Novartis Investigative Site

Berlin, 13507, Germany

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Novartis Investigative Site

Berlin, 13597, Germany

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Novartis Investigative Site

Bielefeld, 33647, Germany

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Novartis Investigative Site

Bochum, 44791, Germany

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Novartis Investigative Site

Bochum, 44793, Germany

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Novartis Investigative Site

Bonn, 53105, Germany

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Novartis Investigative Site

Braunschweig, 38100, Germany

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Novartis Investigative Site

Darmstadt, 64283, Germany

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Novartis Investigative Site

Dresden, 01097, Germany

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Novartis Investigative Site

Düsseldorf, 40212, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Falkensee, 14612, Germany

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Novartis Investigative Site

Freiburg im Breisgau, 79098, Germany

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Novartis Investigative Site

Friedrichshafen, 88045, Germany

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Novartis Investigative Site

Gera, 07548, Germany

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Novartis Investigative Site

Greifswald, 17475, Germany

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Novartis Investigative Site

Hagen, 58095, Germany

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Novartis Investigative Site

Hamburg, 22303, Germany

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Novartis Investigative Site

Hamburg, 22391, Germany

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Novartis Investigative Site

Hanau, 63450, Germany

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Novartis Investigative Site

Hanover, 30625, Germany

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Novartis Investigative Site

Ibbenbueren, 49477, Germany

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Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Löhne, 32584, Germany

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Novartis Investigative Site

Lüdenscheid, 58515, Germany

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Novartis Investigative Site

Magdeburg, 39104, Germany

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Novartis Investigative Site

Magdeburg, 39120, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

Memmingen, 87700, Germany

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Novartis Investigative Site

Mönchengladbach, 41061, Germany

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Novartis Investigative Site

München, 80377, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Oberhausen, 46147, Germany

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Novartis Investigative Site

Oldenburg, 26133, Germany

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Novartis Investigative Site

Osnabrück, 49074, Germany

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Novartis Investigative Site

Plauen, 08529, Germany

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Novartis Investigative Site

Pommelsbrunn, 91224, Germany

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Novartis Investigative Site

Potsdam, 14467, Germany

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Novartis Investigative Site

Quedlinburg, 06484, Germany

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Novartis Investigative Site

Remscheid, 42897, Germany

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Novartis Investigative Site

Seligenstadt, 63500, Germany

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Novartis Investigative Site

Selters, 56242, Germany

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Novartis Investigative Site

Simmern, 55469, Germany

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Novartis Investigative Site

Soest, 59494, Germany

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Novartis Investigative Site

Stuttgart, 70178, Germany

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Novartis Investigative Site

Ulm, 89081, Germany

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Novartis Investigative Site

Vechta, 49377, Germany

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Novartis Investigative Site

Wuppertal, 42109, Germany

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Novartis Investigative Site

Wuppertal, 42349, Germany

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MeSH Terms

Conditions

Psoriasis; Metabolic Syndrome; Diabetes Mellitus; Obesity; Skin Diseases; Plaque, Amyloid; Pruritus

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Skin Manifestations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 22, 2018
• Study Start: February 28, 2018
• Primary Completion: November 30, 2021
• Study Completion: June 3, 2022
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (75)