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    Summary
    EudraCT Number:2017-003286-10
    Sponsor's Protocol Code Number:I6T-MC-AMAJ
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-25
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003286-10
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis

    Studio Multicentrico, Randomizzato, in Doppio Cieco, Controllato con Placebo, per comparare l’Efficacia e la Sicurezza di Mirikizumab rispetto a Secukinumab e Placebo in Pazienti con Psoriasi a placche da Moderata a Grave. OASIS-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Trial in Moderate to Severe Plaque Psoriasis Patients
    Studio di Fase 3 in Pazienti con Psoriasi a placche da Moderata a Grave
    A.3.2Name or abbreviated title of the trial where available
    OASIS-2
    OASIS-2
    A.4.1Sponsor's protocol code numberI6T-MC-AMAJ
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number00441276483597
    B.5.5Fax number00441276483378
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 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 nameMirikizumab (LY3074828)
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for injection
    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 INNMirikizumab
    D.3.9.2Current sponsor codeLY3074828
    D.3.9.4EV Substance CodeSUB177588
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Limited
    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 na
    D.3.4Pharmaceutical form Solution for injection
    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 codeNA
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    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 psoriasis
    Psoriasi a placche da moderata a severa
    E.1.1.1Medical condition in easily understood language
    Psoriasis is a systemic inflammatory disorder that causes red, raised scaly patches on the skin.
    La psoriasi è un disordine infiammatorio sistemico che causa macchie rosse, squamose sulla pelle.
    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
    • Efficacy of mirikizumab induction dosing compared to secukinumab and placebo in subjects based on sPGA (0,1) and PASI 90 at Week 16
    Efficacia del trattamento di induzione con mirikizumab rispetto a secukinumab
    e placebo nei pazienti sulla base di sPGA (0,1) e PASI 90 alla settimana 16
    E.2.2Secondary objectives of the trial
    Efficacy of mirikizumab induction dosing compared to placebo based on PASI 75 at Week 4; PASI 75, PASI 100, BSA =1% , PSS symptoms score of 0 in those with a PSS symptoms score =1 at baseline and DLQI (0,1) with at least a 5-point improvement (reduction) from baseline with DLQI baseline score =5 at week 16
    Efficacia del trattamento di induzione con mirikizumab rispetto a placebo sulla base del PASI 75 alla settimana 4; PASI 75, PASI 100, BSA <=1%, punteggio, PSS per la sintomatologia pari a 0 nei soggetti con un punteggio PSS per la sintomatologia >=1 al basale e DLQI (0,1) con un punteggio DLQI (0,1) alla settimana 16 con almeno 5 punti di miglioramento (riduzione) rispetto al basale con DLQI al basale >=5 alla settimana 16.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Present with chronic plaque psoriasis based on an investigator-confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline, and meet the following criteria::
    a) involving =10% body surface area (BSA) and absolute PASI score =12 in affected skin at screening (Visit 1) and baseline (Visit 2), and
    b) sPGA score of =3 at screening (Visit 1) and baseline (Visit 2).
    - Candidate for systemic therapy and/or phototherapy
    - Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception for the duration of the trial
    - Are =18 years of age
    Il paziente presenta psoriasi a placche cronica in base a diagnosi confermata dallo sperimentatore
    di psoriasis vulgaris cronica da almeno 6 mesi
    prima del basale e soddisfa i criteri seguenti:
    a) interessamento di una superficie corporea (BSA) =10% e punteggio PASI assoluto
    =12 nelle aree cutanee colpite allo screening (visita 1) e al basale (visita 2) e
    b) punteggio sPGA =3 allo screening (visita 1) e al basale (visita 2).
    - Candidato alla terapia sistemica e/o alla fototerapia
    - Le pazienti di sesso femminile devono ottenere un test di gravidanza negativo prima dell’avvio del
    trattamento e devono impegnarsi a utilizzare un metodo contraccettivo per tutta la durata della sperimentazione
    - Età =18 anni
    E.4Principal exclusion criteria
    - Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety within the study or of interfering with the interpretation of data.
    - Are women who are breastfeeding or plan to breastfeed during study
    - Have had serious, opportunistic or chronic/recurring infection within 3 months prior to screening
    - Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.
    - Have any other skin conditions (excluding plaque psoriasis) that would affect interpretation of the results
    - Have received systemic nonbiologic therapy within 28 days prior to baseline
    - Have received topical treatment within 14 days prior to baseline
    - Have prior use of secukinumab
    - Have received anti-tumor necrosis factor (TNF) targeting biologics within 8 weeks prior to baseline
    - Have previous exposure to any biologic therapy targeting IL-12/23 (p40 subunit) or IL-23 (p19 subunit) or IL-17, either marketed or investigational.
    Malattia instabile o non controllata, inclusa (a titolo esemplificativo e non esaustivo)
    malattia cerebrovascolare, respiratoria, epatica, renale, gastrointestinale,
    endocrina, ematologica o neurologica o anomalie dei valori di laboratorio
    allo screening che, a giudizio dello sperimentatore, siano
    suscettibili di compromettere la sicurezza del paziente nel contesto dello studio o di interferire con
    l’interpretazione dei dati.
    - Donne in allattamento o che prevedano di allattare nel corso dello studio
    - Infezione seria, opportunistica o cronica/recidivante nei 3
    mesi precedenti lo screening
    - Vaccinazione con bacillo di Calmette-Guérin (BCG) nei 12
    mesi precedenti o somministrazione di vaccini vivi (inclusi vaccini vivi attenuati)
    nelle 12 settimane precedenti il basale o pazienti che prevedano di assumere uno qualsiasi di tali agenti nel corso dello studio.
    - Presenza di altre condizioni cutanee (diverse dalla psoriasi a placche) suscettibili di
    interferire con l’interpretazione dei risultati
    - Terapia sistemica non biologica nei 28 giorni precedenti il
    basale
    - Terapia topica nei 14 giorni precedenti il basale
    - Uso pregresso di secukinumab
    - Trattamento con biologici anti-fattore di necrosi tumorale (TNF)
    nelle 8 settimane precedenti il basale
    - Esposizione pregressa a qualsiasi terapia biologica diretta contro l’IL-12/23
    (subunità p40) o l’IL-23 (subunità p19) o l’IL-17, in commercio o sperimentale.
    E.5 End points
    E.5.1Primary end point(s)
    Static Physician's Global Assessment (sPGA)(0,1) and Psoriasis Area and Severity Index 90 (PASI 90)
    sPGA (static Physician’s Global Assessment) (0,1) e indice PASI 90
    (Psoriasis Area and Severity Index 90)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints to assess whether mirikizumab induction dosing is superior
    to placebo:
    Week 16- sPGA (0,1) PASI 90
    Timepoints to assess whether mirikizumab induction dosing is
    noninferior to secukinumab:
    Week 16- sPGA (0,1) PASI 90
    Timepoint per la valutazione della superiorità del trattamento di induzione con mirikizumab
    rispetto al placebo:
    Settimana 16 - sPGA (0,1) PASI 90
    Timepoint per la valutazione della non inferiorità del trattamento di induzione con mirikizumab
    rispetto a secukinumab:
    Settimana 16 - sPGA (0,1) PASI 90
    E.5.2Secondary end point(s)
    PASI 75, PASI 100, = BSA with psoriasis involvement, PSS, DLQI, PASI
    90, sPGA (0,1)
    PASI 75, PASI 100, = BSA con interessamento psoriasico, PSS, DLQI, PASI
    90, sPGA (0,1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints to assess whether mirikizumab induction dosing is superior
    to placebo:
    Week 4- PASI 75
    Week 16- PASI 75, PASI 100, BSA =1% with psoriasis involvement, PSS
    symptoms, DLQI
    Timepoints to assess whether mirikizumab induction dosing is
    noninferior to secukinumab:
    Week 24- PASI 90
    Week 52- sPGA (0,1), PASI 90, PASI 100
    Timepoint to assess whether mirikizumab maintenance Q8W dosing is
    superior to secukinumab
    Week 52- sPGA (0,1) PASI 90
    Timepoint per la valutazione della superiorità del trattamento di induzione con mirikizumab
    rispetto al placebo:
    Settimana 4 - PASI 75
    Settimana 16 - PASI 75, PASI 100, BSA =1% con interessamento psoriasico, PSS
    per sintomatologia, DLQI
    Timepoint per la valutazione della non inferiorità del trattamento di induzione con mirikizumab
    rispetto a secukinumab:
    Settimana 24 - PASI 90
    Settimana 52 - sPGA (0,1) PASI 90, PASI 100
    Timepoint per la valutazione della superiorità del trattamento di mantenimento con mirikizumab Q8W rispetto a secukinumab
    Settimana 52 - sPGA (0,1) PASI 90
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Secukinumab
    Secukinumab
    E.8.2.4Number of treatment arms in the trial4
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Israel
    Japan
    Korea, Republic of
    United States
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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: 1340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 Yes
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 638
    F.4.2.2In the whole clinical trial 1443
    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)
    Subject will return to their normal standard of care therapy as determined by their physician or subject if eligible could choose to enter a separate study with long-term mirkizumab treatment.
    I pazienti ritorneranno alla loro terapia standard normale come determinato dai loro medici di base o i soggetti se eleggibili potrebbero scegliere di entrare in uno studio separato con il trattamento a lungo termine di mirkizumab.
    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 Decision2018-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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