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    Summary
    EudraCT Number:2016-001671-79
    Sponsor's Protocol Code Number:CAIN457ADE08
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2016-001671-79
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.3.2Name or abbreviated title of the trial where available
    METABOLYX
    A.4.1Sponsor's protocol code numberCAIN457ADE08
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice
    B.5.3 Address:
    B.5.3.1Street AddressRoonstraße 25
    B.5.3.2Town/ cityNuernberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+491802232300
    B.5.5Fax number+49911273 12160
    B.5.6E-mailinfoservice.novartis@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSecukinumab
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSECUKINUMAB
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe plaque type psoriasis
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    - 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.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker substudy, incorporated within Amendment 2 of clinical study protocol Version 02, dated 5. Sept 2018.

    A biomarker sub-study will be conducted during the core study in a subgroup of 100 patients (50 from each treatment arm) to explore the effect of Secukinumab (300 mg, 4-weekly s.c.) combined with lifestyle intervention in comparison to Secukinumab alone on biomarkers including but not limited to those linked to lipid, glucose, muscle and bone metabolism, liver fibrosis/steatosis, heart failure, as well as to inflammatory processes. At baseline (week 0), week 16 and week 28 the following markers will be assessed using fasting blood samples: Free fatty acid serum profile, sThy-1, adiponectin, leptin, insulin, HOMA-IR, proinsulin, IL-6, TNF-alpha, M30 assay, IL-1 beta, IL-1Ra, IL-18, IL-18bp, P1NP, CTX, RANKL, OPG, sclerostin, NT-proBNP, CD154, and a 30-panel multiplex inflammatory cytokine and chemokines panel.

    The additional risks of participating in the biomarker sub-study are those of blood sampling. Blood sampling will occur at time points where standard blood sampling is scheduled as well, and will not require additional venipuncture. Participation in the sub-study does not negatively affect the overall risk-benefit ratio for participation in the study. Patients eligible for inclusion in the biomarker sub-study will be recruited at study sites participating in the biomarker sub-study. Written informed consent for the biomarker sub-study must be obtained before any assessment for the biomarker sub-study is performed.

    Objective: To explore the effect of Secukinumab (300 mg, 4-weekly s.c.) combined with lifestyle intervention in comparison to Secukinumab alone on biomarkers including but not limited to those linked to lipid, glucose, muscle and bone metabolism, liver fibrosis/steatosis, heart injury, as well as to inflammatory processes in a subgroup of 100 patients (50 treated with secukinumab and lifestyle intervention and 50 treated with secukinumab alone)

    Endpoint: At baseline (week 0), week 16 and week 28 the following markers will be assessed: Free fatty acid serum profile, sThy-1, adiponectin, leptin, insulin, HOMA-IR, proinsulin, IL-6, TNF-alpha, M30 assay, IL-1 beta, IL-1Ra, IL-18, IL-18bp, P1NP, CTX, RANKL, OPG, sclerostin, NT-proBNP, CD154, and a 30-panel multiplex inflammatory cytokine and chemokines panel
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients achieving PASI90 at week 28 in both randomized treatment arms, Secukinumab alone and Secukinumab combined with lifestyle intervention
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 28
    E.5.2Secondary 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Synergistic effect of lifestyle intervention
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lifestyle intervention
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned68
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 680
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state760
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None (subjects who have ended the participation in the trial will be treated according to the physician's discretion)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-02
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