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    Summary
    EudraCT Number:2015-000609-38
    Sponsor's Protocol Code Number:D5170C00002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-08
    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 number2015-000609-38
    A.3Full title of the trial
    A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn?s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy
    Estudio de fase IIb, doble ciego, de dosis múltiples, controlado con placebo para evaluar la eficacia y la seguridad de MEDI2070 en pacientes con enfermedad de Crohn de moderada a grave que han fracasado o no toleran el tratamiento con factor de necrosis antitumoral alfa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy
    Estudio de fase 2B de dosis multiples para evaluar la eficacia y la seguridad de MEDI2070 en pacientes con enfermedad de Crohn que han fracasado o no toleran el tratamiento con factor de necrosis antitumoral alfa
    A.4.1Sponsor's protocol code numberD5170C00002
    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 SponsorMedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK
    B.1.3.4CountryUnited Kingdom
    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 supportMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune
    B.5.2Functional name of contact pointMedImmune Contact
    B.5.3 Address:
    B.5.3.1Street AddressMilstein Building, Granta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0013013982273
    B.5.6E-mailclinicaltrialtransparency@astrazeneca.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 nameMEDI2070
    D.3.2Product code MEDI2070
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number 1610353-18-8
    D.3.9.2Current sponsor codeMEDI2070
    D.3.9.3Other descriptive nameAnti-IL-23 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    Enfermedad de Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 this study is to evaluate the efficacy of MEDI2070 versus placebo to induce clinical remission based on the CDAI score at Week 8 in subjects with moderate to severe CD who have failed or are intolerant to anti-TNF? therapy.
    El objetivo principal de este estudio es evaluar la eficacia de MEDI2070 frente a placebo para inducir una remisión clínica según la puntuación del CDAI en la semana 8 en los pacientes con EC de moderada a grave que han fracasado o no toleran el tratamiento con fármacos antiTNF?.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of MEDI2070 to induce remission based on the SES-CD
    To evaluate the efficacy of MEDI2070 to induce response based on the SES-CD
    To evaluate the efficacy of MEDI2070 to induce remission based on the PRO2
    To evaluate the efficacy of MEDI2070 to induce response based on the PRO2
    To assess the safety and tolerability of MEDI2070
    To evaluate the PK and IM of MEDI2070
    To characterize MEDI2070?s dose-exposure & exposure-response relationships
    To evaluate the efficacy of MEDI2070 to induce clinical response based on the CDAI
    To evaluate the efficacy of MEDI2070 to induce clinical remission based on the CDAI
    To evaluate the efficacy of MEDI2070 on modified sustained remission, based on the SES-CD
    To evaluate the efficacy of MEDI2070 on modified sustained remission based on the PRO2
    To evaluate the efficacy of MEDI2070 on modified sustained remission based on the CDAI
    To assess the relationship of biomarker 1 & biomarker 2 to CDAI remission
    Evaluar la eficacia de MEDI2070 frente a placebo para inducir:
    La remisión según la puntuación endoscópica simplificada de la enfermedad de Crohn (SES-CD) en la semana 16
    La respuesta según la SES-CD en la semana 16
    La remisión según la puntuación de los resultados comunicados por el paciente 2 (RCP2) en la semana 8
    La respuesta según las RCP2 en la semana 8
    La respuesta clínica según el CDAI en la sem 8
    La remisión según las RCP2 en la semana 16
    La remisión según las RCP2 en la semana 16
    La remisión clínica según el CDAI en la semana 16
    La respuesta clínica según el CDAI en la sem 16
    Demostrar la seguridad y tolerabilidad del tratamiento con MEDI2070
    Caracterizar la FC y la inmunogenicidad de MEDI2070
    Caracterizar las relaciones dosis-respuesta y exposición-respuesta
    Evaluar los niveles de los biomarcadores séricos IL-22 y LCN2 por su valor en la predicción de la eficacia de MEDI2070 en la inducción de la respuesta y en la remisión en la sem 16
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Diagnosis of ileal, ileo-colonic, or colonic CD for > 3 months prior to screening
    - Men or women age 18 - 80 years at the time of screening
    - Moderate to severely active CD, as defined by CDAI AND endoscopic demonstration of inflammation
    - Stable dose of medications for Crohn?s disease therapy
    - Prior treatment failure or intolerance with at least one anti-TNF? agent
    -Effective contraception from screening, and for 26 weeks after the last dose of investigational product
    -No known history of active tuberculosis (TB) & negative assessment for TB/latent TB
    - Diagnóstico de EC ilíaca, ileocolónica o colónica durante un mínimo de 3 meses antes de la selección, según la determinación del investigador
    - Edad entre 18 y 80 años, inclusive, en el momento de la selección
    - EC activa de moderada a grave con signos de inflamación activa de la mucosa intestinal, demostrados por revisiones de ileocolonoscopia
    - Los pacientes que tomen alguna de las medicaciones para enfermedad de Crohn deben recibir una dosis estable
    - Tratamiento previo con al menos un fármaco antiTNF? a una dosis aprobada para el tratamiento de la EC sin respuesta inicial
    - Método anticonceptivo desde la selección y 26 semanas después de la última dosis del producto en investigación
    - Pacientes que no tienen antecedentes conocidos de tuberculosis (TB) activa/ TB latente
    E.4Principal exclusion criteria
    -Severe underlying immunosuppression
    - Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation
    - Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization,
    -Recent treatment with approved or investigational biologic therapy for Crohn?s disease
    - Recent or planned live attenuated vaccine
    - History of cancer, except for basal cell carcinoma or CIS of the cervix with apparent cure ? 12 months before screening
    - Pregnancy/breast feeding
    - Drug abuse
    - Inmunosupresión severa subyacente
    - Complicaciones gastrointestinales severas; por ejemplo, síndrome del intestino corto, estenosis con síntomas obstructivos, tener prevista una cirugía intestinal, ileostomía y/o a colostomía, Perforación intestinal reciente.
    - Infecciones significativas durante la selección; Absceso infectado, positivo para Clostridium difficile, infección reciente de hospitalización.
    - Tratamiento previo con terapia biológica para la Enfermedad de Crohn
    - Vacunación reciente o planeada con microorganismos vivos atenuados
    - Antecedentes de cáncer, excepto de carcinoma basocelular o carcinoma in situ del cuello uterino tratado con éxito mediante tratamiento curativo ?12 meses antes de la selección
    - Embarazo/Lactancia
    - Abuso de drogas o alcoholismo
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is CDAI remission at Week 8
    Objetivo principal es la remisión clínica según la puntuación del CDAI en la semana 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    Semana 8
    E.5.2Secondary end point(s)
    Key secondary endpoints (Induction period):
    SES-CD Remission
    SES-CD Response
    PRO2 Remission
    PRO2 Response

    Key secondary endpoints (Maintenance period):
    CDAI remission
    SES-CD Remission
    PRO2 Remission
    CDAI Modified sustained remission
    SES-CD Modified sustained remission
    PRO2 Modified sustained remission

    Safety Endpoints
    Incidence and severity of treatment-emergent adverse events (AEs)
    Incidence of treatment-emergent serious AEs (SAEs)
    Incidence and severity of treatment-emergent AEs of special interest, including:
    Incidence and severity of infection-related AEs and SAEs
    Incidence and severity of infusion/injection-site reactions
    Incidence and severity of hypersensitivity reactions
    Incidence of AEs leading to study drug discontinuation
    Incidence of specific laboratory abnormalities
    Incidence of malignancies
    Presence of antidrug antibodies in serum to MEDI2070
    Objetivos secundarios (periodo de inducción):
    Remisión según SES-CD
    Respuesta según SES-CD
    Remisión según RCP2
    Respuesta según RCP2

    Objetivos secundarios del periodo de mantenimiento:
    Remisión según CDAI
    Remisión según SES-CD
    Remisión según RCP2
    Remisión mantenida modificada según CDAI
    Remisión mantenida modificada según SES-CD
    Remisión mantenida modificada según RCP2

    Criterios de valoración de la seguridad:
    Incidencia e intensidad de los acontecimientos adversos surgidos durante el tratamiento (AAST)
    Incidencia de los acontecimientos adversos graves surgidos durante el tratamiento (AAGST)
    Incidencia e intensidad de los acontecimientos adversos de especial interés surgidos durante el tratamiento (AAEIST), que incluyen:
    Incidencia e intensidad de las reacciones a la infusión/en la zona de inyección
    Incidencia e intensidad de las reacciones de hipersensibilidad
    Incidencia de tumores malignos
    Acontecimientos cardíacos importantes, definidos como infarto de miocardio, accidente cerebrovascular o muerte cardiovascular
    Incidencia e intensidad de los acontecimientos adversos (AA) oculares, incluidas las cataratas
    Incidencia de AA que conlleven la interrupción del tratamiento con el producto en investigación
    Incidencia de anomalías de laboratorio específicas
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8, Week 16 Week 28 and Last study visit - Follow up 28 weeks post last study treatment
    Semana 8, Semana 16 y Semana 28 y última visita - Seguimiento Semana 28 después del tratamiento.
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    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 trial5
    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 EEA75
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Slovakia
    Slovenia
    Spain
    Switzerland
    Turkey
    Ukraine
    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
    Last visit of the last subject undergoing the trial
    Última Visita último paciente del estudio
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 308
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elderly
    Ancianos
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 342
    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)
    Standard of care for patients with Moderate to Severe Crohn?s Disease
    Práctica Clínica Habitual en pacientes con Enfermedad de Crohn moderada a grave
    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 Decision2016-02-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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