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    Summary
    EudraCT Number:2015-004494-33
    Sponsor's Protocol Code Number:2015-004494-33
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-11-13
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-004494-33
    A.3Full title of the trial
    Anti-IL-17, a possible new treatment for contact dermatitis?
    Anti-IL-17, en ny behandlingsmulighed til allergisk betinget kontakteksem?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anti-IL-17, a possible new treatment for contact dermatitis?
    Anti-IL-17, en ny behandlingsmulighed til allergisk betinget kontakteksem?
    A.4.1Sponsor's protocol code number2015-004494-33
    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 SponsorHerlev and Gentofte Hospital
    B.1.3.4CountryDenmark
    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 supportNovartis
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerlev and Gentofte Hospital
    B.5.2Functional name of contact pointDept of dermato-allergology
    B.5.3 Address:
    B.5.3.1Street AddressKildegårdsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.6E-maillone.skov.02@regionh.dk
    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
    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.3.4Pharmaceutical form
    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.3.9.3Other 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) Yes
    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
    allergic contact dermatitis
    allergisk kontaktdermatitis
    E.1.1.1Medical condition in easily understood language
    allergic contact eczema
    allergisk kontakteksem
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10056265
    E.1.2Term Allergic contact dermatitis
    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
    This study will evaluate secukinumab treatment in patients with known allergic contact dermatitis. The study which is an interventional type will consist of two parts both performed at Department of Dermato-allergology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.

    Study 1
    Study 1 will include 10 patients with known allergy to nickel, but with no to low grade of eczema at inclusion.

    1.Reduction in clinical patch test score for dermatitis after secukinumab treatment compared to patch test score before secukinumab treatment in patients challenged with nickel.
    Studiet består af to delforsøg (studie 1 og studie 2). Formålet med studierne samlet er at undersøge om patienter med allergisk betinget kontakt eksem har effekt af behandling med anti-IL-17 (secukinumab).

    Studie 1
    Formålet med studiet er at undersøge, om patienter med allergisk betinget kontakt eksem og som er kendte nikkelallergikere har effekt af behandling med anti-IL-17 (secukinumab) vurderet ved reaktion på lappetest (epikutantest) med nikkel.

    Primært formål
    1. Om der efter behandling med secukinumab ses en klinisk reduktion i graden af eksem vurderet ved reaktion på lappetest sammenlignet med graden af eksem før behandling med secukinumab hos patienter provokeret med nikkel.
    E.2.2Secondary objectives of the trial
    Secondary objective
    2.Reduction in level of inflammation, CD4+, CD8+ T-cells, IFN-ɣ and IL-17 positive cells in punch biopsy after treatment with secukinumab compared to level of inflammation, CD4+, CD8+ T-cells, IFN-ɣ and IL-17 positive cells in punch biopsy before treatment with secukinumab in patients challenged with nickel.
    3.Reduction in skinfold thickness in the nickel patch test area after treatment with secukinumab compared to skinfold thickness in the patch test area before treatment with secukinumab in patients challenged with nickel.
    Sekundært formål
    2.Om der ses reduktion i graden af inflammation og udvalgte immunspecifikke celler i en stansebiopsi efter behandling med secukinumab sammenlignet med graden af inflammation og udvalgte immunspecifikke celler i en stansebiopsi før behandling hos patienter provokeret med nikkel.
    3.Om der ses mindsket hudtykkelse ved hudfoldsmåling efter behandling med secukinumab sammenlignet med hudtykkelse før behandling hos patienter provokeret med nikkel.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study 2
    Study 2 will include 10 patients with more than two known allergic contact allergies and clinically moderate to severe allergic contact dermatitis at inclusion. Patients will be treated open labeled for 8 weeks.
    Primary objective
    1.Reduction in severity of eczema using the PGA score after treatment with secukinumab compared to severity of eczema using the PGA score before treatment with secukinumab.

    Secondary objective
    2.Reduction in DLQI score after treatment with secukinumab compared to DLQI score before treatment with secukinumab.
    3.Reduction in PaGA score after treatment with secukinumab compared to PaGA score before treatment with secukinumab.
    4.Reduction in level of inflammation, CD4+, CD8+ T-cells, IFN-ɣ and IL-17 positive cells in punch biopsy after treatment with secukinumab compared to level of inflammation, CD4+, CD8+ T-cells, IFN-ɣ and IL-17 positive cells in punch biopsy before treatment with secukinumab.
    Studie 2
    Formålet med studiet er at undersøge om patienter med allergisk betinget kontakt eksem og som er kendt med kontaktallergi over for mindst 2 kontaktallergener har effekt af behandling med anti-IL-17 (secukinumab).

    Primært formål
    1.Om der sker en reduktion i graden af eksem målt via Physician Global Assessment score (PGA) efter behandling med secukinumab sammenlignet med graden af eksem før behandling.

    Sekundært formål
    2.Om der ses forbedret livskvalitet målt via Dermatology Life Quality Index (DLQI, bilag 1) efter behandling med secukinumab sammenlignet med livskvaliteten før behandling.
    3.Om der er reduktion i patientens egen vurdering af eksemaktivitet målt via Patient’s Global Assessment score (PtGA) efter behandling med secukinumab sammenlignet med patients egen vurdering af eksemaktivitet før behandling.
    4. Om der ses reduktion i graden af inflammation og udvalgte immunspecifikke celler i en stansebiopsi efter behandling med secukinumab sammenlignet med graden af inflammation og udvalgte immunspecifikke celler i en stansebiopsi før behandling.

    E.3Principal inclusion criteria
    Study1
    Main criteria for inclusion
    Patients must be > 18
    Have a known nickel allergy with at least a +2 reaction when challenged with nickel
    Patients must have given their informed consent to the protocol and the clinical procedures
    Be able to speak and understand Danish.

    Study2
    Main criteria for inclusion
    Patients must be > 18
    Have at least two known contact allergies
    Moderate to severe dermatitis at inclusion
    Failure to local anti-inflammatory treatment and to at least one systemic anti-inflammatory treatment
    Patients must have given their informed consent to the protocol and the clinical procedures
    Be able to speak and understand Danish
    Studie1
    Inklusionskriterier, som alle skal opfyldes:
    Kvinder og mænd, som er mindst 18 år på screeningstidspunktet.
    Kendt med nikkelallergi og som minimum have en +2 reaktion ved lappetest
    Patienten skal være i stand til at kommunikere med forsøgslægen og opfylde de betingelser forsøget stiller samt afgive skriftligt samtykke, før forsøgsrelaterede procedurer kan påbegyndes.

    Studie 2
    Inklusionskriterier, som alle skal opfyldt
    Kvinder og mænd, som er mindst 18 år på screeningstidspunktet
    Kendt med mindst 2 typer af allergisk betinget kontakt allergi
    Moderat til svær eksem ved inklusionstidspunktet
    Manglende behandlingseffekt af lokal antiinflammatorisk behandling og mindst én type af systemisk antiinflammatorisk behandling.
    Patienten skal være i stand til at kommunikere med forsøgslægen og opfylde de betingelser forsøget stiller samt afgive skriftligt samtykke, før forsøgsrelaterede procedurer kan påbegyndes

    E.4Principal exclusion criteria
    Study 1
    Main criteria for exclusion
    Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0
    Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0
    Patients who have received any other study medication 4 weeks prior to day 0
    Dermatitis at the upper inner arm
    Patients with clinically significant disorders
    Patients with active TB/serious infections
    Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception.
    Pregnancy
    Nursing
    Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study
    Latex allergy

    Study2
    Main criteria for exclusion
    Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0
    Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0 Patients who have received any other study medication 4 weeks prior to day 0
    Patients with clinically significant disorders
    Patients with active TB/serious infections
    Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception.
    Pregnancy
    Nursing
    Patients who have received any weakened vaccines 6 weeks prior to day 0 or who are planning to receive a weakened vaccine during the study
    Latex allergy
    Studie1
    Eksklusionskriterier, hvor ingen af disse må opfyldes:
    Behandling med lokal antiinflammatorisk medicin inden for 2 uger før forsøgets påbegyndelse
    Behandling med systemisk antiinflammatorisk medicin inden for 4 uger før forsøgets påbegyndelse
    Behandling med forsøgsmedicin inden for 4 uger før baseline
    Patienter med eksem på indersiden af overarmen
    Gravide eller ammende kvinder
    Fertile kvinder skal anvende sikker prævention i hele forsøgsperioden og op til 16 uger efter behandlingsstop med secukinumab. Sikker prævention er p-piller, spiral, depotindsprøjtning af gestagen, hormonstav indsat under huden, hormonal vaginalring, depotplaster, pessar eller kondom med sæddræbende creme. Sterilitet eller overgangsalder som er stoppet for mere end 12 måneder siden fritages for prævention.
    Patienter med alvorlige kendte sygdomme
    Patienter med aktiv TB/alvorlige infektionssygdomme
    Planlagt levende vaccine under forsøget eller 6 uger før baseline.
    Latexallergi

    Studie2
    Eksklusionskriterier, hvor ingen af disse må opfyldes:
    Behandling med lokal antiinflammatorisk medicin inden for 2 uger før forsøgets påbegyndelse
    Behandling med systemisk antiinflammatorisk medicin inden for 4 uger før forsøgets påbegyndelse
    Behandling med forsøgsmedicin inden for 4 uger før baseline
    Gravide eller ammende kvinder
    Fertile kvinder skal anvende sikker prævention i hele forsøgsperioden og op til 16 uger efter behandlingsstop med secukinumab. Sikker prævention er p-piller, spiral, depotindsprøjtning af gestagen, hormonstav indsat under huden, hormonal vaginalring, depotplaster, pessar eller kondom med sæddræbende creme. Sterilitet eller overgangsalder som er stoppet for mere end 12 måneder siden fritages for prævention.
    Patienter med alvorlige kendte sygdomme
    Patienter med aktiv TB/alvorlige infektionssygdomme
    Planlagt levende vaccine under forsøget eller 6 uger før baseline.
    Latexallergi
    E.5 End points
    E.5.1Primary end point(s)
    Please see section E2
    Se venligst sektion E2
    E.5.1.1Timepoint(s) of evaluation of this end point
    1/7-17
    1/7-17
    E.5.2Secondary end point(s)
    Please see section E2
    Se venligst sektion E2
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/7-17
    1/7-17
    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 No
    E.6.5Efficacy No
    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 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.8.2.4Number of treatment arms in the trial7
    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
    LVLS
    LVLS
    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 Yes
    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 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
    ingen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-04-25
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