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    Summary
    EudraCT Number:2012-004098-26
    Sponsor's Protocol Code Number:CD-IA-MEDI2070-1147/D5170C00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-11
    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 number2012-004098-26
    A.3Full title of the trial
    A Phase 2a 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 II per valutare l’efficacia e la sicurezza di MEDI2070 in soggetti con Morbo di Crohn di grado da moderato a severo dopo il fallimento o l’intolleranza ad una terapia con Anti-TNFα
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of MEDI2070 in patients with active,
    moderate-to-severe Crohn's disease.
    Valutazione dell'efficacia e della sicurezza di MEDI2070 in pazienti con Morbo di Crohn di grado da moderato a severo
    A.3.2Name or abbreviated title of the trial where available
    MEDI 2070
    MEDI 2070
    A.4.1Sponsor's protocol code numberCD-IA-MEDI2070-1147/D5170C00001
    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 SponsorASTRAZENECA
    B.1.3.4CountryItaly
    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 Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information
    B.5.3 Address:
    B.5.3.1Street AddressClinical Study Information
    B.5.3.2Town/ cityClinical Study Information
    B.5.3.3Post code20080
    B.5.3.4CountryItaly
    B.5.4Telephone number001 800 2369933
    B.5.5Fax number001 800 2369933
    B.5.6E-mailinformation.center@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
    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.3.9.2Current sponsor codeMEDI2070
    D.3.9.3Other descriptive nameanticorpo monoclonale anti IL-23
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    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
    Crohn's Disease
    Morbo di Crohn
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease
    Malattia infiammatoria intestinale
    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 14.1
    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
    To evaluate the efficacy of MEDI2070 versus placebo to induce a clinical effect (defined as at least a 100-point reduction in Crohn's Disease Activity Index [CDAI] from baseline) or remission at Week 8 in subjects with moderate to severe Crohn's disease.
    Valutare l’efficacia di MEDI2070, rispetto al placebo nell’indurre un effetto clinico (definito come riduzione dell’indice CDAI -Crohn’s Disease Activity Index- di almeno 100 punti rispetto al baseline) o una remissione alla settimana 8, in soggetti con morbo di Crohn (CD) di grado da moderato a severo
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of MEDI2070 versus placebo in achieving CDAI remission (defined as CDAI < 150) at Week 8 To evaluate the effect of MEDI2070 versus placebo in achieving at least a CDAI 100-point reduction from baseline at Week 8 To evaluate the effect of MEDI2070 versus placebo in achieving at least a CDAI 70-point reduction from baseline at Week 8 To evaluate the effect of MEDI2070 versus placebo in achieving CDAI remission or at least a CDAI 100-point reduction from baseline at Week 12 To evaluate the effect of MEDI2070 versus placebo on the change from baseline in CDAI at Week 8 To evaluate the safety and tolerability of MEDI2070 To evaluate the pharmacokinetics (PK) and immunogenicity (IM) of MEDI2070
    Valutare l’efficacia di MEDI2070 rispetto al placebo nel raggiungimento della diminuzione del CDAI (definita come CDAI&lt;150), alla Settimana 8
    Valutare l’effetto di MEDI2070 rispetto al placebo nel raggiungimento della riduzione del CDAI di almeno 100 punti rispetto al basale alla Settimana 8
    Valutare l’effetto di MEDI2070 rispetto al placebo nel raggiungimento della riduzione del CDAI di almeno 70 punti rispetto al basale, alla Settimana 8
    Valutare l’effetto di MEDI2070 rispetto al placebo nel raggiungimento della remissione del CDAI o nel raggiungimento della riduzione del CDAI di almeno 100 punti rispetto al baseline , alla Settimana 12
    Valutare l’effetto di MEDI2070 rispetto al placebo in termini di variazione del CDAI rispetto al basale, alla Settimana 8
    Valutare la sicurezza e la tollerabilità di MEDI2070
    Valutare la farmacocinetica (PK) e l’immunogenicità (IM) di MEDI2070
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening. Men or women age 18 - 65 years at the time of screening. Moderate-severe active CD, defined by a CDAI score of ≥ 220 and ≤ 450 at Day 1. No known history of active TB. Received at least one anti-TNFα agent for the treatment of CD and did not initially respond.
    Diagnosi di Morbo di Cronh a livello ileale, ileo-colonico o colonico per un minimo di 6 mesi prima dello screening come stabilito dallo sperimentatore;
    maschi e femmine di età compresa tra 18 e 65 anni al momento dello screening
    Morbo di Cronh attivo con grado da moderato a severo , definito da un risultato dell’indice CDAI compreso tra 220 e 450 al giorno 1;
    Soggetti che non hanno una storia conosciuta di TB attiva
    Soggetti che abbiano ricevuto almeno un farmaco anti-TNFα alla dose approvata per il trattamento del Morbo di Cronh e che non hanno risposto inizialmente
    E.4Principal exclusion criteria
    Pregnant or breastfeeding women. Presence of ileostomy and/or colostomy. Short bowel syndrome. Bowel performation or obstruction. History of cancer.
    Donne in gravidanza o allattamento
    Soggetti con ileostomia o colostomia
    Soggetti con sindrome dell’intestino corto
    Perforazione intestinale o evidenza di ostruzione non infiammatoria
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is CDAI response at Week 8, defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points
    L'endpoint primario dello studio è la risposta CDAI alla settimana 8, definita o come punteggio CDAI <150 o come una riduzione del CDAI rispetto al basale pari almeno a 100 punti.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    settimana 8
    E.5.2Secondary end point(s)
    1- CDAI remission at Week 8, as defined by a CDAI score of < 150 2- A reduction of at least 100 points from baseline in CDAI at Week 8 3- A reduction of at least 70 points from baseline in CDAI at Week 8 4- CDAI response (either remission defined by CDAI < 150 or a CDAI reduction from baseline of at least 100 points from baseline) at Week 12 5- Change from baseline CDAI at Week 8 6- Pharmacokinetic (PK) evaluation of Multiple Doses of MEDI2070 7- Immunogenicity (IM) evaluation of Multiple Doses of MEDI2070
    1 - remissione del CDAI alla settimana 8, definito come punteggio CDAI <150
    2 - Una riduzione CDAI
    di almeno 100 punti rispetto al basale alla settimana 8
    3 - Una riduzione CDAI di almeno 70 punti rispetto al basale alla settimana 8
    4 - risposta CDAI (o remissione definita da CDAI <150 o CDAI
    riduzione rispetto al basale di almeno 100 punti rispetto ai valori basali) alla settimana 12)
    5 - Variazione CDAI
    dal basale alla settimana 8
    6 - farmacocinetica (PK) valutazione di dosi multiple di MEDI2070
    7 - Immunogenicità (IM) la valutazione di dosi multiple di MEDI2070
    E.5.2.1Timepoint(s) of evaluation of this end point
    secondary endpoint 1, 2, 3 and 5 - Week 8 secondary endpoint 4 - week 12 secondary endpoint 6 - Week 0(Visit 3), Week 4 (Visit 5), Week 8 (Visit 6) predose; Week 0(Visit 3), Week 4 (Visit 5) postdose secondary endpoint 7 - Week 0(Visit 3), Week 8 (Visit 6) postdose
    - SE n° 1, 2, 3 aned 5 - settimana 8
    - SE n°4 - settimana 12
    - SE n° 6 - settimana 0(Visit 3), settimana 4 (Visit 5), settimana 8 (Visit6) predose; settimana 0(Visit 3), settimana 4 (Visit 5) postdose
    - SE n° 7 - settimana 0(Visit 3), settimana 8 (Visit 6) postdose
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    immunogenicità
    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 Yes
    E.8.1.7.1Other trial design description
    In aperto dalla settimana 12 alla 112
    Open label from week 12 to week 112
    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 EEA30
    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
    Canada
    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
    LSLV (compreso il contatto telefonico)
    LSLV (compreso il contatto telefonico)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months45
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months46
    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: 0
    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: 120
    F.1.3Elderly (>=65 years) No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 120
    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)
    None
    Nessuno
    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 Decision2013-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
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