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    Summary
    EudraCT Number:2015-002433-22
    Sponsor's Protocol Code Number:I1F-MC-RHBF
    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:2015-10-30
    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 number2015-002433-22
    A.3Full title of the trial
    A Phase 3, Multicenter Study with a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period from Week 36 to Week 104 to Evaluate the Long Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug?Naive Patients with Active Psoriatic Arthritis
    Estudio en fase III, multicéntrico, con un periodo abierto de 36 semanas, seguido de un periodo de retirada aleatorizado y doble ciego desde la semana 36 hasta la semana 104 para evaluar la eficacia y la seguridad a largo plazo del ixekizumab (LY2439821) 80 mg cada 2 semanas en pacientes con artritis psoriásica activa que nunca han recibido un fármaco antirreumático biológico modificador de la enfermedad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
    Un estudio de Ixekizumab in participantes con Artritis Psoriasica activa.
    A.3.2Name or abbreviated title of the trial where available
    Spirit 3
    A.4.1Sponsor's protocol code numberI1F-MC-RHBF
    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 and Company
    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 & 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 pointRocio Arce (SA Manager for Spain)
    B.5.3 Address:
    B.5.3.1Street AddressAvda. de la Industria 30.
    B.5.3.2Town/ cityAlcobendas Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number003491663 34 73
    B.5.6E-mailarce_rocio@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 nameIxekizumab
    D.3.2Product code LY2439821
    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 INNIXEKIZUMAB
    D.3.9.1CAS number 1143503-69-8
    D.3.9.2Current sponsor codeLY2439821
    D.3.9.3Other descriptive nameMonoclonal antibody
    D.3.9.4EV Substance CodeSUB176389
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 infusion in pre-filled syringe
    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
    Arthritic Psoriasis
    Artritis psoriásica
    E.1.1.1Medical condition in easily understood language
    A type of arthritis associated with psoriasis
    Un tipo de artritis asociada con la psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    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
    The primary objective of the study is to compare ixekizumab 80 mg Q2W with placebo in maintenance of treatment response, as measured by the time to relapse during the randomized double-blind withdrawal period in cDMARD-IR and bDMARD-naive patients with active PsA who meet randomization criteria (Coates criteria for MDA for 3 consecutive months over 4 consecutive visits).
    El objetivo principal del estudio es comparar el ixekizumab 80 mg cada 2 semanas (C2S) con el placebo en el mantenimiento de la respuesta al tratamiento, medida por el tiempo hasta la recaída durante el periodo de retirada aleatorizado con doble ciego en pacientes con una respuesta inadecuada (RI) a fármacos antirreumáticos modificadores de la enfermedad convencionales (FARMEc) y en pacientes no tratados con fármacos antirreumáticos modificadores de la enfermedad biológicos (FARMEb) con APs activa que cumplen los criterios de aleatorización (criterios de Coates para la actividad mínima de la enfermedad [MDA] durante 3 meses consecutivos a lo largo de 4 visitas consecutivas).
    E.2.2Secondary objectives of the trial
    compare ixekizumab 80mg Q2W with placebo in maintenance of treatment response,measured by the proportion of patients who meet relapse criteria during the randomized double-blind withdrawal period in cDMARD-IR and bDMARD-naive patients with active PsA who meet randomization criteria (Coates criteria for MDA for 3 consecutive mths over 4 consecutive visits)
    evaluate the time to loss of response for each individual component of MDA in the randomized double-blind withdrawal period
    evaluate time to first meeting Coates criteria for MDA during the initial open-label treatment period
    evaluate time to achieving Coates criteria for MDA during the initial open-label treatment period (Coates criteria for MDA for 3 consecutive mths over 4 consecutive visits)
    assess the efficacy of ixekizumab 80mg Q2W after disease relapse after
    randomization in the randomized double-blind treatment period
    assess effect of treatment response as measured by the HAQ-DI of ixekizumab 80mg Q2W throughout study
    Comparar el ixekizumab 80 mg C2S con el placebo en el mantenimiento de la respuesta al tratamiento, medida por la proporción de pacientes que cumplen los criterios de recaída durante el periodo de retirada aleatorizado con doble ciego en pacientes con RI a FARMEc y pacientes no tratados con FARMEb con APs activa que cumplen los criterios de aleatorización
    Evaluar el tiempo hasta la pérdida de respuesta para cada componente individual de la MDA en el periodo de retirada aleatorizado con doble ciego y el tiempo hasta el cumplimiento del primer criterio de Coates para la MDA durante el periodo de tratamiento inicial abierto y el tiempo hasta lograr los criterios de Coates para la MDA durante periodo 2.
    Evaluar la eficacia del ixekizumab 80 mg C2S tras la recaída de la enfermedad después de la aleatorización en el periodo de tratamiento aleatorizado y doble ciego y efecto de la respuesta al tratamiento medida por el Índice de discapacidad del cuestionario de evaluación de la salud
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] are male or female patients 18 years or older who agree to use reliable method of birth control or remain abstinent during the study
    [2] have had diagnosis of active PsA for at least 6 months and meet Classification for Psoriatic Arthritis (CASPAR) criteria
    [3] active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
    [4] have been treated with 1 or more conventional disease-modifying antirheumatic drugs (DMARDs)
    [5] have active psoriatic skin lesions (plaque) or a documented history of plaque psoriasis
    Los pacientes solamente serán elegibles para participar en el estudio si cumplen todos los criterios siguientes:
    [1] Pacientes de ambos sexos de 18 años en adelante quienes acepten el uso de metodos anticonceptivos o abstencion durante el estudio.
    [2]Tener un diagnóstico de APs activa durante al menos 6 meses cumplir actualmente con los criterios CASPAR.
    [3] Tener APs activa, definida como la presencia de al menos 3 articulaciones y 3 articulaciones
    [4] Haber sido tratado con 1 o más FARMEc
    [5] Tener lesiones psoriásicas cutáneas activas (placas) o antecedentes documentados de psoriasis en placas.
    E.4Principal exclusion criteria
    Patients will be excluded from study enrollment if they meet any of the following criteria:
    [7] have received any previous treatment or are currently receiving treatment with any biologic or small-molecule therapy for PsA or psoriasis
    [10] have had, in the opinion of the investigator, inadequate response to treatment with ?4 cDMARDs or immune modifiers
    [12] are receiving treatment with more than 1 cDMARD
    [20] have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study
    [24] have a diagnosis of other inflammatory arthritic syndromes such as RA, ankylosing spondylitis, reactive arthritis, or enteropathic arthritis
    [33] have serious disorder other than psoriatic arthritis
    [36] had a serious infection within 12 weeks
    [43] are positive for human immunodeficiency virus serology
    [44] have evidence of or test positive for hepatitis B or hepatitis C virus
    [50] are women who are lactating or breastfeeding
    Los pacientes que cumplan cualquiera de los siguientes criterios serán excluidos de la inscripción del estudio:
    [7] Haber recibido o estar actualmente recibiendo tratamiento con cualquier tratamiento biológico o de moléculas pequeñas para la APs o la psoriasis
    [10] Haber tenido, en opinión del investigador, una respuesta insuficiente al tratamiento con ? 4 FARMEc o modificadores de la respuesta inmunitaria
    [12] Estar recibiendo tratamiento con más de 1 FARMEc
    [20] Presentar una alergia o hipersensibilidad conocidas a algún tratamiento biológico que suponga un riesgo inaceptable al paciente en caso de participación en el estudio.
    [24] Tener diagnosticada otra artropatía inflamatoria como AR, espondilitis anquilosante, artritis reactiva o artritis enteropática.
    [33]Tener otro trastorno grave que no sea la artritis psoriásica
    [43] Ser seropositivo para el virus de la inmunodeficiencia humana
    [44] Presentar evidencia o dar positivo en una prueba de detección de hepatitis B o hepatitis C
    [50] Ser mujeres en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Relapse as defined by loss of Coates Criteria for MDA
    Recaída definida como dejar de cumplir los criterios de Coates para la MDA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 104 weeks.
    Hasta 104 semanas.
    E.5.2Secondary end point(s)
    Tender and swollen joint count, enthesitis, PASI, patient reported outcomes (PRO).
    Recuento de articulaciones inflamadas, entesitis, PASI, Paciente que informa (PRO).
    E.5.2.1Timepoint(s) of evaluation of this end point
    36-64 weeks; 104 weeks
    36-64 semanas; 54 semanas
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    La inmunogenicidad
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Período abierto seguido de periodo doble ciego
    Open-Label period followed by Double Blind period
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Bulgaria
    Czech Republic
    Estonia
    Mexico
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Ukraine
    United Kingdom
    United States
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 400
    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)
    Subjects will return to their normal standard of care therapy as determined by their physician.
    Los sujetos volverán a su terapia normal y a la atención según lo determine su médico.
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-30
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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
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