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    Summary
    EudraCT Number:2015-000609-38
    Sponsor's Protocol Code Number:D5170C00002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-21
    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 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
    Studio di Fase 2b, in doppio cieco, a dosi multiple, controllato con placebo per valutare l’efficacia e la sicurezza di MEDI2070 in soggetti affetti da morbo di Crohn da moderato a grave con risposta inadeguata o intolleranza alla terapia anti-fattore di necrosi tumorale 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
    Studio di Fase 2b a dosi multiple per valutare la sicurezza e i benefici del trattamento con MEDI2070 in in soggetti affetti da morbo di Crohn con risposta inadeguata o intolleranza alla terapia anti-fattore di necrosi tumorale alfa
    A.3.2Name or abbreviated title of the trial where available
    nd
    nd
    A.4.1Sponsor's protocol code numberD5170C00002
    A.5.4Other Identifiers
    Name:ndNumber:nd
    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, LLC
    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
    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.5.5Fax 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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1610353-18-8
    D.3.9.2Current sponsor codeMEDI2070
    D.3.9.3Other descriptive nameanticorpo monoclonale anti-IL-23
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease
    Morbo di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    Morbo di 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 20.0
    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-TNFα therapy.
    L'obiettivo primario di questo studio è valutare l’efficacia di MEDI2070 rispetto al placebo nell’indurre la remissione clinica in base al punteggio CDAI alla Settimana 8 in soggetti affetti da CD da moderato a grave con risposta inadeguata o intolleranza alla terapia anti-TNFα.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of MEDI2070 to induce remission based on theSES-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
    Valutare l’efficacia di MEDI2070 rispetto al placebo nell’indurre:
    - la remissione alla Sett 16 in base al punteggio SES-CD;
    - una risposta alla Sett 16 in base al punteggio SES-CD.
    - la remissione alla Sett 8 in base al punteggio a 2 voci degli esiti riferiti dai pazienti (PRO2).
    - una risposta alla Sett 8 in base al punteggio PRO2.
    - una risposta clinica alla Sett 8 in base al punteggio CDAI.
    - la remissione alla Sett 16 in base al punteggio PRO2.
    - una risposta alla Sett 16 in base al punteggio PRO2
    - la remissione clinica alla Sett 16 in base al punteggio CDAI
    -una risposta clinica alla Sett 16 in base al punteggio CDA
    - Dimostrare la sicurezza e tollerabilità della terapia con MEDI2070
    - Caratterizzare la PK e l’immunogenicità di MEDI2070.
    - Caratterizzare le relazioni dose-risposta ed esposizione-risposta
    - Valutare i liv sierici di IL-22 e LCN2 per determinarne l’importanza nel predire l’efficacia di MEDI2070 in relazione all’induzione di risposta e remissione alla Sett 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-TNFα 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
    - Diagnosi di CD ileale, ileocolico o colico risalente a un minimo di 3 mesi prima dello screening
    - Soggetti ambosessi di età compresa tra 18 e 80 anni, al momento dello screening
    - CD da moderatamente a gravemente attivo, come definito da CDAI E evidenza endoscopica di infiammazione
    - In terapia con dose stabile di farmaci per CD
    - Fallimento di un precedente trattamento con o intolleranza ad almeno un agente anti TNFα
    - Contraccezione efficace a partire dallo screening e per 26 settimane dopo l’ultima dose del prodotto sperimentale
    - Nessuna anamnesi nota di tubercolosi (TBC) attiva & valutazione negativa per TBC/TBC 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
    - Grave immunosoppressione di base
    - Gravi complicazioni gastrointestinali; es, sindrome dell'intestino corto, stenosi ostruttive, chirurgia intestinale recente o prevista, ileostomia
    e / o colostomia, recente perforazione intestinale
    - Infezioni significative allo screening; Ascessi infetti, positività per Clostridium difficile, recente ricovero infettivo
    - Trattamento recente con terapia biologica approvati o in fase di sperimentazione per
    Morbo di Crohn
    - Somministrazione recente o pianificata di vaccino vivo attenuato
    - Anamnesi di tumore, a eccezione di carcinoma basocellulare o carcinoma in situ della cervice trattati con apparente successo mediante terapia curativa ≥ 12 mesi prima dello screening.
    - Gravidanza / allattamento
    - Abuso di droghe
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is CDAI remission at Week 8
    Endpoint primario è la remissione clinica CDAI alla Settimana 8
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    Settimana 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
    Endpoint secondari del periodo di induzione:
    • remissione SES-CD
    • risposta SES-CD
    • remissione PRO2
    • risposta PRO2
    Endpoint secondari del periodo di mantenimento:
    • remissione clinica CDAI
    • remissione SES-CD
    • remissione PRO2
    • remissione clinica CDAI sostenuta modificata
    • remissione SES-CD sostenuta modificata
    • remissione PRO2 sostenuta modificata
    Endpoint di sicurezza:
    • incidenza e gravità degli eventi avversi emergenti dal trattamento (TEAEs)
    • incidenza degli eventi avversi (EA) seri emergenti dal trattamento
    • incidenza e gravità degli eventi avversi di speciale interesse (AESI) emergenti dal trattamento, tra cui:
    ◦ incidenza e gravità di AEs e SAEs correlati a infezione
    ◦ incidenza e gravità delle reazioni nel sito di iniezione/infusione;
    ◦ incidenza e gravità delle reazioni da ipersensibilità
    • incidenza degli EA che portano a interruzione del prodotto sperimentale;
    • incidenza di specifiche anomalie di laboratorio.
    ◦ incidenza di neoplasie maligne
    - presenza di anticorpi anti farmaco nel siero per MEDI2070
    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
    Settimana 8, Settimana 16 Settimana 28 e Ultima visita di studio
    Follow up 28 settimane dopo l'ultimo trattamento di studio
    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 concerned11
    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 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
    Austria
    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
    Ultima visita dell'ultimo oggetto sottoposto alla sperimentazione
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elderly
    anziani
    F.4 Planned number of subjects to be included
    F.4.1In the member state37
    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
    Standard di cura per i pazienti con malattia di Crohn da moderata 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 Decision2016-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-01-29
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