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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-003937-84
    Sponsor's Protocol Code Number:I1F-MC-RHBW
    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:2016-02-03
    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 number2015-003937-84
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients with Radiographic Axial Spondyloarthritis
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo durante 16 semanas, seguido de una evaluación a largo plazo de la eficacia y la seguridad de ixekizumab (LY2439821), en pacientes con espondiloartritis axial radiológica que han recibido antiTNF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ixekizumab in Patients with Axial Spondyloarthritis who have Previously Taken Tumor Necrosis Factor Inhibitors for Their Condition.
    Estudio de Ixekizumab en pacientes con espondiloartritis axial que hayan recibido inhibidores del factor de necrosis del tumor para su condición
    A.3.2Name or abbreviated title of the trial where available
    CoASt-W
    A.4.1Sponsor's protocol code numberI1F-MC-RHBW
    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
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressAvda de la Industria nº 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number34916635327
    B.5.5Fax number34916633481
    B.5.6E-mailalonsoaj@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 nameLY2439821
    D.3.2Product code Ixekizumab
    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.3.9.3Other descriptive nameLY2439821
    D.3.9.4EV Substance CodeSUB30469
    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 injection 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
    Radiographic Axial Spondyloarthritis
    Espondiloartritis axial radiografica
    E.1.1.1Medical condition in easily understood language
    A chronic inflammatory condition affecting the spine and sacroiliac joint. It is characterized by pain and stiffness of joints.
    Condicion inflamatoria crónica que afecta a la articulación sacroiliaca y espinal. Se caracteriza por dolor y rigidez en las articulaciones.
    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 10041672
    E.1.2Term Spondylitis ankylosing
    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
    Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) vs placebo in tumor necrosis factor inhibitor (TNFi) experienced patients with active radiographic axial spondyloarthritis (r-axSpA) at Week 16.
    Comparar, en la semana 16, dos pautas posológicas de ixekizumab (80 mg C2S u 80 mg C4S) con el placebo, en pacientes con EpAax-radiologicamente activa.
    E.2.2Secondary objectives of the trial
    To compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) to placebo at Week 16 on signs and symptoms, function, mobility, and quality of life in TNFi experienced patients with r-axSpA.
    Comparar ambas pautas posológicas de ixekizumab (80 mg cada 2 semanas u 80 mg cada 4 semanas) con el placebo en la semana 16 respecto a signos y sintomas, funcinalidad, mobilidad y calidad de vida en pacientes con EpAax-radiologicamente activa.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is a MRI substudy that will be conducted in selected countries. Patients will have MRIs of the spine at screening and at Week 16. The MRI addendum version is 23Nov2015.
    Se va a realizar un subestudio de Resonancia Magnética Nuclear (RMN) en determinados paises. Este subestudio no se realizará en España. Se realizará a los pacientes una Resonancia Magnética Nuclear de la columna vertebral en la semana 16. El addendum de RMI es de versión del 23Nov2015.
    E.3Principal inclusion criteria
    -Are at least 18 years of age
    -Have an established diagnosis of radiographic axial spondyloarthritis (r-axSpA) with sacroiliitis defined
    radiographically according to the mNY criteria
    -Patients have a history of back pain ?3 months with age at onset <45 years.
    -Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
    -Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least
    4 weeks OR have a history of intolerance to NSAIDs.
    -Have given written informed consent
    -Pacientes que en el momento de la selección tengan por lo menos 18 años.
    -Presentar un diagnóstico establecido de espondiloartritis axial radiológica(EpAax-rad) con sacroilitis, definida radiológicamente de acuerdo con los criterios NYm.
    -Presentar antecedentes de dolor de espalda durante un mínimo de 3 meses y que esta haya aparecido antes de los 45 años.
    -Haber recibido anteriormente al menos 1 y como máximo 2 inhibidores del TNF.
    -Haber presentado una respuesta insuficiente a 2 o más AINEs en el intervalo de dosis terapéuticas durante una duración total de al menos 4 semanas O presentar antecedentes de intolerancia a AINE.
    -Haber proporcionado el consentimiento informado por escrito
    E.4Principal exclusion criteria
    - Have total ankylosis of the spine
    -Have taken none or more than two tumor necrosis factor inhibitor medications
    - Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
    - Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis
    - Have a compromised immune system.
    - Have any other serious and/or uncontrolled diseases.
    - Have either a current diagnosis or a recent history of malignant disease.
    - Have had Major surgery within 8 weeks of baseline, or will require surgery during the study
    - Are pregnant or breastfeeding
    -Presentar anquilosis total de la columna vertebral
    -No haber recibibido tratamiento con inhibidores de TNF, o haber recibido tartamiento con más de dos.
    -Haber recibido una vacuna con el bacilo de Calmette y Guérin (BCG) en el último año.
    -Presentar evidencia de una infección grave en el último año o evidencia de tuberculosis activa
    -Tener el sistema inmune comprometido
    -Padecer cualquier otra enfermedad grave o incontrolada.
    -Tener una neoplasia maligna activa o antecedentes de neoplasias malignas reciente.
    -Haberse sometido a una intervención de cirugía mayor en el transcurso de las 8 semanas previas a la aleatorización basal, o que deba someterse a una intervención de cirugía mayor durante el estudio
    -Estar embarazada o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response.
    Porcentaje de pacientes que alcancen una respuesta ASAS40 (Assessment of Spondyloarthritis International Society 40)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    -Proportion of patients achieving an ASAS20 response
    -Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
    -Proportion of patients achieving Bath Ankylosing
    Spondylitis Disease Activity Index 50 (BASDAI50) response
    -Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
    -Proportion of patients achieving ASDAS inactive disease
    -Change from baseline in Short Form 36 (SF-36) physical component score (PCS)
    -Change from baseline in ASAS Health Index (ASAS HI)
    -Change from baseline in magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] ?Berlin score). (This endpoint applies to MRI addendum only).
    ?Porcentaje de pacientes que alcancen una respuesta ASAS20.
    ?Variación respecto al período basal en la puntuación de la actividad de la enfermedad para la espondilitis anquilosante (ASDAS).
    ?Porcentaje de pacientes que alcancen una respuesta de 50 en el Índice de Bath de actividad de la enfermedad para la espondilitis anquilosante (BASDAI50).
    ?Variación respecto al período basal en el Índice funcional de Bath para la espondilitis anquilosante (BASFI).
    ?Porcentaje de pacientes que pasen a presentar enfermedad inactiva, de acuerdo con la puntuación ASDAS.
    ?Variación respecto al período basal en la puntuación del componente físico (PCF) del cuestionario abreviado de salud de 36 ítems (SF-36).
    ?Variación respecto al período basal en el índice de salud ASAS (ASAS HI).
    ?Variación respecto al período basal en las resonancias magnéticas nucleares (RMN) de la columna vertebral (Resonancia magnética nuclear de la columna vertebral en la espondilitis anquilosante [ASSpiMRI] - puntuación de Berlín). (Este criterio de valoración es aplicable únicamente a la adenda de RMN).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    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 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) 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 No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA44
    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
    Brazil
    Canada
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Puerto Rico
    Spain
    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
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 179
    F.4.2.2In the whole clinical trial 300
    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)
    Patients that complete Study RHBW may be eligible to enroll into a long-term study (Study I1F-MC-RHBY) for up to 2 additional years. Patients that do not enroll into Study RHBY will complete the Post-Treatment Follow-Up Period in Study RHBW and resume standard of care treatment as prescribed by their physician.
    Los pacientes que completen el estudio RHBW podrán considerarse idóneos para participar en un estudio a largo plazo (estudio I1F-MC-RHBY ) durante 2 años adicionales. Los pacientes que no se recluten en el estudio RHBY completarán el período de seguimiento posterior al tratamiento (período 4) del estudio RHBW y recibirán el tratamiento standard prescrito por 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 Decision2016-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-03
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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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