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    Summary
    EudraCT Number:2013-002709-79
    Sponsor's Protocol Code Number:AMC_MoA_IL17
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-01-16
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-002709-79
    A.3Full title of the trial
    Mechanism of action study of anti-IL17 treatment in spondyloarthritis: Impact on cellular and molecular pathways of synovial inflammation and tissue remodeling.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mechanism of action study of anti-IL17 treatment in spondyloarthritis.
    Werkingsmechanisme van anti-IL17 therapie in spondyloartritis.
    A.3.2Name or abbreviated title of the trial where available
    Mechanism of action of anti-IL17 in spondyloarthritis
    A.4.1Sponsor's protocol code numberAMC_MoA_IL17
    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 SponsorAcademic Medical Center, Department of Rheumatology
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAcademic Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center, department of Rheumatology
    B.5.2Functional name of contact pointdepartment of Rheumatology
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205667765
    B.5.5Fax number+31206916658
    B.5.6E-maild.l.baeten@amc.uva.nl
    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 No
    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 typeup to
    D.3.10.3Concentration number300
    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 No
    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
    Spondyloarthritis
    Spondyloartritis
    E.1.1.1Medical condition in easily understood language
    Spondyloarthritis
    Spondyloartritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10032155
    E.1.2Term Other inflammatory spondylopathies
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10070759
    E.1.2Term Spondylopathy
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efect of IL-17 blockade on:
    - the global synovial histology and inflammatory infiltration
    - the number and type of IL-17 producing cells in SpA synovitis
    - the productuion of inflammatory mediators (including other IL-17 related cytokines and TNF) by PBMC and total tissue biopsies (ex vivo culture system)
    - The synovial stromal cell signature
    - The pan-genomic synovial gene expression profile\

    Onderzoeken wat het effect is van anti-IL17 therapie op:
    - de globale synoviale histologie en het inflammatoire infiltraat
    - het aantal en het type anti-IL17producerende cellen in SpA synovitis
    - de productie van inflammatoire mediatoren (zoals andere IL-17 gerelateerde cytokines en TNF) door PBMC's en de weefsel biopten (in een ex-vivo culture-system)
    - de synoviale stromale cell kenmerken
    - het pan-genomic synoviale gen-expresssie profiel

    E.2.2Secondary objectives of the trial
    Secondary:
    To compare wich molecular disease pathways are affected by IL-17 blockade and not by TNF blockade and thereby identify molecular biomarkers which may help to determine which patients may benefit form this treament in comparison with anti-TNF treatment.
    To assess wether AIN457 sileces vessel wall inflammation (by means of 18F-FDG PET/CT of the carotic arteries and aorta.
    Secundair:
    Vergelijken welke moleclaire ziekte-pathways beinvloed zijn door IL-17 blokkade en niet door TNF blokkade, en hiermee het identificeren van biomarkers die helpen de bepalen welke patienten voordeel zullen hebben van de therapie met anti IL17 in vergelijking met anti-TNF.
    Het onderzoeken of de AIN457 (secukinumab) de vaatwand inflammatie beinvloed (door middel van een 18F-FDG PET/CT van de carotiden en de aorta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or non-pregnant/non-lactating females age 18-70
    - Diagnosis of SpA according to ESSG criteria and/or ASAS criteria
    - Active disease defined by ≥1 swollend and ≥ 1 tender joint, and at least 1 swollen knee or ankle joint at baseline
    - stable dose of concomitant medication (NSAIDs etc.)
    - Mannen en niet zwangere/niet borstvoeding gevende vrouwen tussen 18 en 70 jaar
    - Diagnose Spondylartropatie volgens ESSG of ASAS criteria
    - Actieve ziekte, gedefinieerd als ≥ 1 gezwollen en ≥ 1 pijnlijk gewricht, waaronder minimaal 1 gezwollen knie of enkel bij baseline
    - stabiele dosering van bijkomende medicatie
    E.4Principal exclusion criteria
    - Evidence for infectious or malignant process (on chest X ray/MRI etc)
    - Pts taking opioid angalgetics
    - Previous IL-17 therapy exposure
    - Previous use of celldepleting therapies, biological immunomodulants (except for a.TNF)
    - Significant medical problems or diseases
    - Aanwijzingen voor infect of maligne proces op beeldvorming/ een actuele ziekte
    - Opiaat gebruik
    - Voorgaande anti-IL17 therapie
    - Voorgaande cell-depleting therapien en biologicals (behalve anti-TNF)
    - Medische problemen, lab afwijkingen die mogelijk niet samengaan met studie participatie
    E.5 End points
    E.5.1Primary end point(s)
    - Changes in the synovial cellular and molecular pathways as indicated in the objectives between baseline and week 12
    Veranderingen in syoviale cellulaire en moleculaire pathways zoals beschreven in de objectives, tussen baseline en week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline compared with week 12
    baseline vergeleken met week 12
    E.5.2Secondary end point(s)
    - Stratification of these cellular and molecular changes according to the genetic biomarkers of relevance for anti-IL17 treatment response
    - Correlation between the synovial features at baseline and the clinical response at week 12
    - Comparison of the synovial molecular changes induced by anti-IL17 with the changes induced by anti-TNF (historical samples in a similar patient population and study setting)
    - Comparison of the changes in Target to Background Ration (TBR) as an indicator of vessel wall inflammation assessed by FDG PET/CT of the aorta and carotid arteries
    - verandering van cellulaire en moleculaire relateren aan genetische biomarkers relevant in de anti-IL17 respons
    - correlatie tussen synoviale kenmerken tussen baseline and de klinische respons op week 12
    - vergelijking van de moleculaire veranderingen van het synovium geinduceerd door anti-IL17 met de veranderingen geinduceerd door anti-TNF therapie (in historische samples in een vergelijkbare patienten populatie en studie-opzet)
    - vergelijking van de veranderingen in Target to Background Ration (TBR) als een indicator voor vaatwand inflammatie beoordeeld met een FDG PET/CT van de aorta en carotiden
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    week 12
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Patient will be treated for up to 2 years in an open label setting.
    After the last visit of the last patient the trial will be ended.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    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
    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 Decision2014-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
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