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    Summary
    EudraCT Number:2015-001925-18
    Sponsor's Protocol Code Number:GED-0301-CD-002
    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:2016-01-04
    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 number2015-001925-18
    A.3Full title of the trial
    A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn?s disease.
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo para investigar la eficacia y seguridad de mongersen (GED-0301) para el tratamiento de sujetos con enfermedad de Crohn activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn?s disease
    Estudio para evaluar el fármaco Mongersen (GED-0301) para el tratamiento de la enfermedad de Crohn.
    A.3.2Name or abbreviated title of the trial where available
    A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease
    Estudio doble ciego aleatorizado para explorar la eficacia y seguridad de GED-0301 en la enfermedad
    A.4.1Sponsor's protocol code numberGED-0301-CD-002
    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 SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34914229000
    B.5.5Fax number+19132660394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 nameMongersen
    D.3.2Product code GED-0301
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmongersen
    D.3.9.1CAS number 1443994-98-6
    D.3.9.2Current sponsor codeGED-0301
    D.3.9.4EV Substance CodeSUB30963
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 typeantisense-oligonucleotide
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Crohn's disease
    Enfermedad de Crohn activa
    E.1.1.1Medical condition in easily understood language
    Crohn?s disease (an Inflammatory Bowel Disease)
    Enfermedad de Crohn (Enfermedad intestinal inflamatoria)
    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 LLT
    E.1.2Classification code 10021315
    E.1.2Term Ileitis terminal
    E.1.2System Organ Class 100000004856
    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 GED-0301 compared with placebo on clinical activity, as measured by the Crohn?s Disease Activity Index (CDAI) in subjects with active Crohn?s disease (CD).
    Evaluar la eficacia de GED-0301 en comparación con placebo sobre la actividad clínica, medida por el índice de actividad de la enfermedad de Crohn (Crohn?s Disease Activity Index, CDAI) en sujetos con EC activa
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of GED-0301 compared with placebo on endoscopic outcomes, as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD) in subjects with active CD;
    To evaluate the efficacy of GED-0301 compared with placebo on corticosteroid-free clinical remission in subjects with active CD;
    To evaluate the long-term efficacy of GED-0301 compared with placebo on clinical activity and endoscopic outcomes in subjects with active CD;
    To evaluate the safety and tolerability of GED-0301 in subjects with active CD.
    Evaluar la eficacia de GED-0301 en comparación con placebo sobre resultados endoscópicos, medida por la puntuación endoscópica simplificada de la enfermedad de Crohn (Simple Endoscopic Score for Crohn's Disease, SES-CD) en sujetos con EC activa
    Evaluar la eficacia de GED-0301 en comparación con placebo sobre las remisiones clínicas sin corticoesteroides en sujetos con EC activa
    Evaluar la eficacia a largo plazo de GED-0301 en comparación con placebo sobre la actividad clínica y los resultados endoscópicos en sujetos con EC activa
    Evaluar la seguridad y tolerabilidad de GED-0301 en sujetos con EC 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
    A PK substudy (sparse PK study) was incorporated into the study at selected study sites to monitor for
    systemic exposure of GED-0301 in subjects with active CD. Intensive collection of PK samples will be performed in a subset of subjects that have a CDAI score of ? 300 and ? 450, with a minimum of 16 participants. An intensive PK sub-study is not taking place in the Member State concerned by this application
    Se ha incorporado un subestudio FC al estudio en centros del estudio seleccionados para supervisar la exposición sistémica de GED-0301 en sujetos con EC activa. La recogida intensiva de muestras FC se realizará en una subpoblación de sujetos que tengan puntuaciones del CDAI de ? 300 y ? 450, con un mínimo de 16 participantes. El subestudio de FC intensivo no tendrá lugar en el Estado Miembro al que se refiere esta presentación
    E.3Principal inclusion criteria
    Diagnosis of CD with a duration of at least 3 months prior to the Screening Visit
    Diagnosis of ileitis, ileocolitis or colitis, as determined by endoscopic, radiographic or any other imaging modality (eg, magnetic resonance imaging [MRI], computed tomography [CT] scan)
    Active disease, defined as a CDAI score ? 220 and ? 450 at screening
    Subject must have a 7-day average stool frequency ? 3.5 or abdominal pain ? 1.5 at screening
    Subject must have a total SES-CD ? 6 at screening, or the ileum segmental SES-CD ? 4 at screening
    Must have failed or experienced intolerance to at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (ie, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]); or biologics for the treatment of CD
    Diagnóstico de EC de una duración mínima de 3 meses antes de la visita de selección
    Diagnóstico de ileitis, ileocolitis o colitis, determinado por medios endoscópicos, radiológicos o cualquier otra técnica de imagen (p. ej., resonancia magnética [RM], tomografía axial computarizada [TAC])
    Enfermedad activa definida como una puntuación CDAI ? 220 y ? 450 en la selección
    El sujeto debe presentar una frecuencia promedio durante 7 días de deposiciones ? 3,5 o dolor abdominal ? 1,5 en la selección
    El sujeto debe presentar una SES-CD total ? 6 en la selección o una SES-CD en el segmento ileal ? 4 en la selección
    Tiene que haber fracasado o haber experimentado intolerancia a por lo menos alguno de los siguientes elementos: aminosalicilatos; budesonida; corticoesteroides sistémicos; inmunosupresores (como azatioprina [AZA], 6-mercaptopurina [6-MP] o metotrexato [MTX]), o tratamiento biológico para el tratamiento de la EC
    E.4Principal exclusion criteria
    Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
    Subject has local manifestations of CD such as strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
    Subject had any intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
    Subject had prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) within 8 weeks prior to the Screening Visit
    Use of intravenous (IV) corticosteroids within 2 weeks prior to the Screening Visit
    Use of topical treatment such as 5-aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks prior to the Screening Visit
    Use of cholestyramine within 3 weeks prior to the Screening Visit
    Prior treatment with more than 3 biologics for the treatment of CD
    Treatment with a biologic within 8 weeks prior to the Screening Visit
    Prior treatment with natalizumab
    Diagnóstico de colitis ulcerosa (CU), colitis indeterminada, colitis isquémica, colitis microscópica, colitis por radiación o enfermedad diverticular asociada a colitis
    El sujeto tiene manifestaciones locales de EC como estenosis, abscesos, síndrome de intestino corto u otras complicaciones de la enfermedad para las cuales podría estar indicada la cirugía o que podrían confundir la evaluación de la eficacia
    El sujeto ha sido sometido a una resección intestinal en los 6 meses anteriores o a cualquier cirugía intraabdominal en los 3 meses previos a la visita de selección
    El sujeto recibió tratamiento previo con ácido micofenólico, tacrolimús, sirolimús, ciclosporina, talidomida o aféresis (p. ej., Adacolumn®) en las 8 semanas previas a la visita de selección
    Uso de corticoesteroides intravenosos (i.v.) en las 2 semanas previas a la visita de selección
    Uso de tratamiento tópico, como enemas de ácido 5-aminosalicílico (5-ASA) o de corticoesteroides o supositorios en las 2 semanas previas a la visita de selección
    Uso de colestiramina en las 3 semanas previas a la visita de selección
    Tratamiento previo con más de 3 productos biológicos para el tratamiento de la EC
    Tratamiento con un producto biológico en las 8 semanas previas a la visita de selección
    Tratamiento previo con natalizumab
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy as clinical remision: the proportion of subjects achieving clinical remission defined as a Crohn?s Disease Activity Index (CDAI) score < 150 at Week 4
    La proporción de sujetos que logra remisión clínica, definida como una puntuación del CDAI < 150 en la semana 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4
    Semana 4
    E.5.2Secondary end point(s)
    The proportion of subjects with mucosal healing defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ? 2 at Week 12, Week 52
    The proportion of subjects with a reduction of at least 50% from baseline in SES-CD at Week 12, Week 52
    The proportion of subjects achieving clinical remission defined as a CDAI score < 150 at Week 12, Week 52
    The proportion of subjects who achieve corticosteroid-free clinical remission at Week 52 among subjects receiving oral corticosteroids at baseline
    The proportion of subjects with an average daily liquid or soft stool frequency ? 3 and abdominal pain score ? 1 at Week 4, Week 12, Week 52
    The proportion of subjects with an average daily liquid or soft stool frequency ? 1.5 and abdominal pain score ? 1 at Week 4, Week 12, Week 52
    Type, frequency, severity, seriousness, and relationship of AEs to IP (Investigational Product) through Week 52
    Number of subjects who discontinue IP due to any AE (Adverse Event) through Week 52
    Clinically significant changes in vital signs and/or laboratory findings through Week 52
    La proporción de sujetos con curación de la mucosa, definida como una SES-CD ? 2 en la semana 12 y la semana 52
    La proporción de sujetos con una reducción del 50 %, como mínimo, con respecto al valor inicial de la SES-CD en la semana 12 y la semana 52
    La proporción de sujetos que logran remisión clínica definida como una puntuación del CDAI < 150 en la semana 12 y en la semana 52
    La proporción de sujetos que logran una remisión clínica sin corticoesteroides en la semana 52 de entre todos los sujetos que recibían corticoesteroides orales en el momento inicial
    La proporción de sujetos con una frecuencia promedio diaria de deposiciones líquidas o blandas ? 3 y una puntuación de dolor abdominal ? 1 en la semana 4, la semana 12 y la semana 52
    La proporción de sujetos con una frecuencia promedio diaria de deposiciones líquidas o blandas ? 1,5 y una puntuación de dolor abdominal ? 1 en la semana 4, la semana 12 y la semana 52
    Tipo, frecuencia, intensidad, gravedad y relación de los AA con el PEI
    Número de sujetos que interrumpe el tratamiento con el producto en investigación (PEI) debido a algún AA
    Alteraciones clínicamente significativas en las constantes vitales, en el electrocardiograma (ECG) y/o en los resultados analíticos
    E.5.2.1Timepoint(s) of evaluation of this end point
    as given above
    Los referidos más arriba
    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 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 No
    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 trial4
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA311
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Korea, Republic of
    Latvia
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    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
    End of Study is defined as either the date of the LVLS to complete the post-treatment follow-up, or the date of receipt of the last data point from the LS that is required for primary, secondary and/or exploratory analysis, as prespecified in the protocol, whichever is the later date.
    El fin del estudio se define o bien como la fecha de la última visita del último sujeto para completar el seguimiento posterior al tratamiento o bien como la fecha de recepción del último apunte de datos del último sujeto requerido para el análisis primario, secundario y/o exploratorio, según se especifica previamente en el protocolo, lo que suceda más tarde.
    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 months2
    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: 1010
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 452
    F.4.2.2In the whole clinical trial 1064
    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
    Ninguno
    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 Decision2016-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-01-05
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