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    Summary
    EudraCT Number:2012-002432-93
    Sponsor's Protocol Code Number:NN8828-4004
    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:2012-10-02
    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 number2012-002432-93
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn?s disease
    Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la eficacia y seguridad clínica de NNC0114-0006 en sujetos con enfermedad de Crohn activa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn?s disease
    Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la eficacia y seguridad clínica de NNC0114-0006 en sujetos con enfermedad de Crohn activa.
    A.4.1Sponsor's protocol code numberNN8828-4004
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1130-8441
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114, VTB
    B.5.3.2Town/ citySoeborg
    B.5.3.3Post codeDK-2860
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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.3.2Product code 0114-0006B
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeNNC0114-0006
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeCHO -derived monoclonal antibody. Anticuerpo monoclonal derivado de ovario de hamster chino.
    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
    Crohns disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease, autoimmune disease that causes inflammation in the gut
    Enfermedad inflamatoria intestinal, enfermedad que causa inflamación en el intestino.
    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 15.0
    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
    To compare the effect on disease activity of a single i.v. dose of NNC0114-0006 with placebo in subjects with moderately to severely active Crohn?s disease
    Comparar el efecto sobre la actividad de la enfermedad de una dosis única i.v. de NNC0114-0006 con un placebo en sujetos con enfermedad de Crohn de actividad moderada o grave
    E.2.2Secondary objectives of the trial
    - To describe the pharmacokinetics (PK) of NNC0114-0006
    - To compare pharmacodynamic (PD) effects of NNC0114-0006 and placebo
    - To compare the effects of NNC0114-0006 and placebo on mucosal healing in a subgroup of subjects
    - To compare the effects of NNC0114-0006 and placebo on the use of concomitant medication for Crohn?s disease
    - To compare the effects of NNC0114-0006 and placebo on patient reported outcomes (PROs)
    - To describe the safety and tolerability of NNC0114-0006
    - To describe the immunogenicity of NNC0114-0006
    ?Describir la farmacocinética (FC) de NNC0114-0006
    ?Comparar los efectos farmacodinámicos (FD) de NNC0114-0006 y del placebo
    ?Comparar los efectos de NNC0114-0006 y del placebo en la cicatrización de la mucosa en un subgrupo de sujetos
    ?Comparar los efectos de NNC0114-0006 y del placebo en la utilización de medicación concomitante para la enfermedad de Crohn
    ?Comparar los efectos de NNC0114-0006 y del placebo en los resultados comunicados por los pacientes (RCP)
    ?Describir la seguridad y la tolerabilidad de NNC0114-0006
    ?Describir la inmunogenicidad de NNC0114-0006.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Moderately to severely active Crohn?s disease, defined as a CDAI of 220-450 (both inclusive) at Visit 2 (Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) ?10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Screening).
    - Men and women between ?18 and ?75 years of age
    - Biologic-naïve subjects or biologic-experienced for the treatment of Crohn?s disease. Biologic-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of Crohn?s disease due to lack of efficacy (primary or secondary efficacy failures).
    ?Enfermedad de Crohn de actividad moderada o grave, definida como una puntuación CDAI de 220-450 (ambas inclusive) en la visita 2 (administración), con indicios de inflamación confirmados mediante un valor de proteína C reactiva (PCR) ?10 mg/l o verificación endoscópica (de acuerdo con el manual de endoscopia) obtenida en la visita 1 (selección)
    ?Varones y mujeres de entre ?18 y ?75 años de edad
    ?Sujetos tratados o no tratados previamente con fármacos biológicos para la enfermedad de Crohn. Los sujetos tratados previamente con fármacos biológicos son elegibles si no han presentado fracaso a más de un tratamiento biológico para la enfermedad de Crohn debido a falta de eficacia (fracasos de eficacia primario y secundario ).
    E.4Principal exclusion criteria
    - Body mass index (BMI) ?38.0 kg/m^2
    - Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated
    - History of dysplasia in the colon
    ?Índice de masa corporal (IMC) ?38,0 kg/m2
    ?Cualquiera de los criterios siguientes: obstrucción intestinal sintomática, síndrome del intestino corto, ileostomía o colostomía, resección intestinal quirúrgica en los 6 meses previos a la aleatorización, colectomía total o colectomía subtotal con menos de 20 cm de colon conservados, cualquier absceso no tratado debidamente
    ?Antecedentes de displasia de colon
    ?Cualquier infección bacteriana activa o en curso en las 4 semanas previas a la aleatorización, salvo que se haya tratado y resuelto con el tratamiento adecuado
    ?Antecedentes de infecciones recurrentes graves que precisaron hospitalización.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Crohn?s disease activity index (CDAI)
    Variación del índice de actividad de la enfermedad de Crohn.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 4
    Desde el momento basal hasta la semana 4
    E.5.2Secondary end point(s)
    1. Change in CDAI
    2. Clinical remission, defined as CDAI of less than 150
    3. Change in the inflammatory bowel disease questionnaire (IBDQ) score
    4. Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores
    5. Incidence of adverse events (AEs)
    6. Incidence of anti-NNC0114-0006 antibodies
    1. Variación de la puntuación del CDAI
    2. Remisión clínica, definida como un CDAI menor de 150.
    3. Variación de la puntuación del cuestionario de la enfermedad intestinal inflamatoria (inflammatory bowel disease questionnaire, IBDQ)
    4. Variaciones de las puntuaciones de los componentes físico y mental del Cuestionario de salud abreviado (Short Form Health Survey, SF-36v2)
    5. Incidencia de acontecimientos adversos (AA) 6. Incidencia de anticuerpos anti-NNC0114-0006
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline to Week 12
    2. At Week 8
    3. From baseline to Week 4
    4. From baseline to Week 4
    5. Up to Weeks 24 or 36
    6. Up to Weeks 24 or 36
    1. Desde el momento basal hasta la semana 12.
    2. En la semana 8
    3. Desde el momento basal hasta la semana 4.
    4. Desde el momento basal hasta la semana 4.
    5. Hasta las semanas 24 o 36.
    6. Hasta las semanas 24 o 36.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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
    Tolerability, immunogenicity, patient reported outcomes
    Tolerabilidad, inmunogenicidad, desenlaces comunicados por los pacientes.
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Bulgaria
    Czech Republic
    Hungary
    Poland
    Russian Federation
    Serbia
    Slovakia
    Spain
    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
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days9
    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: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 114
    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)
    N/A
    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 Decision2012-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-12-19
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