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    Summary
    EudraCT Number:2017-003286-10
    Sponsor's Protocol Code Number:I6T-MC-AMAJ
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-16
    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 ConcernedSpain - AEMPS
    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
    Estudio multicéntrico, aleatorizado, con doble enmascaramiento y controlado con placebo, para evaluar la eficacia y seguridad de mirikizumab con secukinumab y placebo en pacientes con psoriasis en placas moderada a grave
    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
    Estudio en fase 3 en pacientes con psoriasis en placas moderada a grave
    A.3.2Name or abbreviated title of the trial where available
    OASIS-2
    A.4.1Sponsor's protocol code numberI6T-MC-AMAJ
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 organisationLilly S.A.
    B.5.2Functional name of contact pointMª Pilar López
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number0034916231218
    B.5.6E-mailensayosclinicos@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.3.4Pharmaceutical 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.3.9.3Other descriptive nameMIRIKIZUMAB
    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 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.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.3.4Pharmaceutical 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.3.9.3Other descriptive nameSECUKINUMAB
    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 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
    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
    Psoriasis en placas moderada o grave
    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 psoriasis es un trastorno inflamatorio generalizado que provoca enrojecimiento, protuberancias y descamación cutáneas.
    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
    Eficacia del tratamiento de inducción con mirikizumab respecto a la de secukinumab y el placebo, de acuerdo con el porcentaje de pacientes que alcancen un índice sPGA (0, 1) y una respuesta PASI 90 en la semana 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 and DLQI (0,1) with DLQI baseline score >1 at Week 16

    • Efficacy of mirikizumab maintenance dosing compared to secukinumab based on PASI 90 at Week 24; sPGA(0,1), PASI 90, PASI 100 at week 52
    Eficacia del tratamiento de inducción con mirikizumab respecto a la del placebo, de acuerdo con el porcentaje de pacientes que alcancen una respuesta PASI 75 en la semana 4; el porcentaje de pacientes que en la semana 16 alcancen una respuesta PASI 75, una respuesta PASI 100, tengan ≤ 1 % de la superficie corporal afectada, presenten una puntuación de 0 en la escala de los síntomas de la psoriasis (PSS) y cuya puntuación basal en esta escala fuera ≥ 1 y alcancen un índice DLQI (0,1) y cuya puntuación basal en este índice fuera > 1.
    Eficacia del tratamiento de mantenimiento con mirikizumab respecto a la de secukinumab, de acuerdo con el porcentaje de pacientes que alcancen una respuesta PASI 90 en la semana 24; y un índice sPGA (0, 1), una respuesta PASI 90 y PASI 100 en la semana 52.
    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
    - Presencia de psoriasis en placas crónica de acuerdo con el diagnóstico confirmado por el investigador de psoriasis vulgar crónica al menos desde 6 meses antes del período basal y que el paciente cumpla los criterios siguientes:
    a) afectación ≥ 10 % de la superficie corporal (SC) y puntuación total en el índice PASI ≥ 12 en la piel afectada en la selección (visita 1) y en el período basal (visita 2), y
    b) puntuación ≥ 3 en la evaluación sPGA en la selección (visita 1) y en el período basal (visita 2).

    - Tributario de tratamiento sistémico o fototerapia.
    - Las mujeres deben presentar un resultado negativo en una prueba de embarazo antes del inicio del tratamiento y estar de acuerdo en utilizar métodos anticonceptivos durante el estudio.
    - Tener ≥ 18 años.
    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.
    - Presentar en la selección una enfermedad inestable o sin controlar, entre otras, cerebro-cardiovasculares, respiratorias, hepáticas, renales, gastrointestinales, endocrinas, hematológicas o neurológicas o valores analíticos anormales que, según el criterio del investigador, supongan un riesgo para la seguridad del paciente durante el estudio o interfieran en la interpretación de los datos.
    - Mujeres que den el pecho o tengan previsto hacerlo durante el estudio.
    - Infección oportunista o crónica/recurrente y grave en el transcurso de los 3 meses anteriores a la selección.
    - Haber recibido una vacuna con el bacilo de Calmette-Guérin (BCG) en los 12 últimos meses o una vacuna elaborada con microbios vivos (incluidas las atenuadas) en el transcurso de las 12 semanas anteriores al período basal o tener previsto recibir una vacuna de este tipo durante el estudio.
    - Presentar cualquier otra enfermedad cutánea (salvo la psoriasis en placas) que afecte la interpretación de los resultados.
    - Haber recibido tratamiento sistémico con productos no biológicos en el transcurso de los 28 días anteriores al período basal.
    
- Haber recibido tratamiento tópico en el transcurso de los 14 días anteriores al período basal.
    - Haber recibido secukinumab anteriormente.
    - Haber recibido productos biológicos dirigidos al factor de necrosis tumoral (TNF) en el transcurso de las 8 semanas anteriores al período basal.
    - Haber recibido anteriormente cualquier tratamiento biológico dirigido a la IL-12/23 (subunidad p40), la IL-23 (subunidad p19) o la IL-17, tanto comercializados como en investigación.
    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)
    Evaluación estática global por parte del médico (sPGA)(0, 1) e índice de gravedad y área de la psoriasis 90 (PASI 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
    Momentos en los que se evaluará si el tratamiento de inducción con mirikizumab es superior al placebo:

    Semana 16: sPGA (0,1), PASI 90
    Momentos en los que se evaluará si el tratamiento de inducción con mirikizumab no es inferior a secukinumab:

    Semana 16: sPGA (0, 1), PASI 90.
    E.5.2Secondary end point(s)
    PASI 75, PASI 100, BSA ≤1% with psoriasis involvement, PSS, DLQI, PASI 90, sPGA (0,1)
    PASI 75, PASI 100, ≤ SC afectada con psoriasis, 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
    Momentos en los que se evaluará si el tratamiento de inducción con mirikizumab es superior al placebo:

    Semana 4: PASI 75

    Semana 16: PASI 75, PASI 100, ≤ 1 % de la SC afectada con psoriasis, síntomas (PSS), DLQI

    Momentos en los que se evaluará si el tratamiento de inducción con mirikizumab no es inferior a secukinumab:

    Semana 24: PASI 90

    Semana 52: sPGA (0, 1), PASI 90, PASI 100

    Momento en el que se evaluará si el tratamiento de mantenimiento con mirikizumab es superior a secukinumab: Semana 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
    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 concerned12
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Poland
    Spain
    United Kingdom
    United States
    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
    Última visita del último paciente
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 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 state72
    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.
    El paciente reanudará el tratamiento habitual (de acuerdo con el criterio del médico) o, si cumple los requisitos, podrá optar por participar en otro estudio en el que se evaluará el tratamiento a largo plazo con mirikizumab.
    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 Decision2018-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-03
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