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    Summary
    EudraCT Number:2015-001963-37
    Sponsor's Protocol Code Number:GED-0301-CD-004
    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:2018-02-23
    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 number2015-001963-37
    A.3Full title of the trial
    A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease
    Studio di estensione di fase 3 con trattamento attivo a lungo termine di mongersen (GED-0301) in soggetti con morbo di Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease
    Studio di estensione di fase 3 con trattamento attivo a lungo termine di mongersen (GED-0301) in soggetti con morbo di Crohn
    A.3.2Name or abbreviated title of the trial where available
    A long-term study to explore the safety of GED-0301 in Crohn's disease
    Studio di estensione di fase 3 con trattamento attivo a lungo termine di mongersen (GED-0301) in sog
    A.4.1Sponsor's protocol code numberGED-0301-CD-004
    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 pointClinical Trial Disclosure
    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 number0018882601599
    B.5.5Fax number0019132660394
    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 IMP
    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 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 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
    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
    Malattia di Crohn attiva
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease (an Inflammatory Bowel Disease)
    Malattia di Crohn (Malattia infiammatoria dell'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 20.0
    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 long-term safety of oral GED-0301 in subjects with Crohn’s disease
    Valutare la sicurezza a lungo termine di GED-0301 per via orale nei soggetti affetti da malattia di Cronh
    E.2.2Secondary objectives of the trial
    Secondary objectives are not included in this study.
    Non sono inclusi obiettivi secondari in questo studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is a male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
    2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
    3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
    4. Subject must have completed through Week 12 in the previous GED-0301 study AND either:
    Completed participation through the last study treatment visit
    at Week 52 in Study GED-0301-CD-002 or at Week 12 in Study GED-0301-CD-003 OR Met the “early escape criteria” and were discontinued after Week 12 in Study GED-0301-CD-002.
    5. Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and enrollment (Visits 1 and 2). While on IP and for at least 28 days after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options
    6. Male subjects when engaging in sexual activity with females who are able to become pregnant must use barrier contraception while on IP and for at least 28 days after the last dose.
    1. Il soggetto è un maschio o femmina ≥ 18 anni di età al momento della firma del modulo di consenso informato (ICF).
    2. Il soggetto deve comprendere e firmare volontariamente un ICF prima di essere condotti eventuali valutazioni / procedure correlate allo studio.
    3. Il soggetto è disposto e in grado di aderire al programma di visite di studio e gli altri requisiti del protocollo.
    4. Il soggetto deve aver completato fino alla settimana 12 nello studio precedente GED-0301 e:
    - aver completato fino alla 52 ^ settimana di studio GED-0301-CD-002 o alla settimana 12 nello studio GED-0301-CD-003 oppure deve aver soddisfatto i "criteri precoci di uscita" e interrotto dopo 12 settimane nello studio GED-0301-CD-002.
    5. Le femmine in età fertile (FCBP) devono avere un test di gravidanza negativo allo screening e all'arruolamento (Visite 1 e 2). Durante il trattamento con farmaco sperimentale (IP) e per almeno 28 giorni dopo aver preso l'ultima dose di IP, FCBP che si impegnano in attività in cui è possibile il concepimento devono utilizzare una delle opzioni contraccettive approvate
    6. soggetti maschi se coinvolti in atti sessuali con soggetti femminili che sono in grado di rimanere incinta devono usare contraccettivi di barriera durante il trattamento con IP e per almeno 28 giorni dopo l'ultima dose.
    E.4Principal exclusion criteria
    1. Subject had experienced a serious adverse event related to the IP while participating in the previous Phase 3 GED-0301 study.
    2. Subject has any continuing serious medical condition, laboratory abnormality, or psychiatric illness that occurred while participating in the previous Phase 3 GED-0301 study.
    3. Subject has or had a flare or worsening of CD that, in the opinion of the Investigator, would not be in the best interest for the subject to participate in this long-term active treatment study.
    4. Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.
    5. Subject has been diagnosed with colorectal cancer or colorectal dysplasia (with the exception of adenomatous colonic polyps that have been completely resected) while participating in the previous Phase 3 GED-0301 study.
    6. Subject has a newly diagnosed malignancy while participating in the previous Phase 3 GED-0301 study.
    7. Subject is pregnant or breastfeeding.
    8. Subject has been newly diagnosed with substance abuse.
    9. Subject has developed a known hypersensitivity to oligonucleotides, GED-0301 or any ingredient in the IP.
    1. Soggetti che hanno avuto un evento avverso grave correlato al IP durante la partecipazione al precedente studio di Fase 3 con GED-0301.
    2. Soggetti che presentano una persistente condizione medica seria, anomalie di laboratorio o malattia psichiatrica, verificatesi durante la partecipazione nel precedente studio di Fase 3 GED-0301.
    3.Il soggetto ha o ha avuto un'allargamento o un peggioramento di CD che, a giudizio dello sperimentatore, non giustificherebbe la partecipazione del soggetto allo studio
    4. Soggetto ha assunto agenti biologici, compresi i bloccanti del TNF-α o gli antagonisti dell’integrina
    5.al soggetto è stato diagnosticato cancro colonrettale o displasia colonrettale durante la partecipazione al precedente studio di fase 3 con GED-0301
    6. Soggetto a cui è statao diagnosticato un tumore durante la partecipazione al precedente studio di fase 3 con GED-0301
    7. soggetto in gravidanza o allattamento
    8. soggetto al quale è stato recentemente diagnosticato un abuso di sostanze.
    9. soggetto che ha sviluppato ipersensibilità a oligonucleotidi, GED-0301 o agli altri componenti del farmaco sperimentale.
    E.5 End points
    E.5.1Primary end point(s)
    Safety of GED-0301, assessed by type, frequency and severity of adverse events, and its relationship to investigational product, discontinuation due to adverse events, and clinically significant changes in electrocardiograms (ECGs), vital signs, and/or laboratory findings
    Sicurezza di GED-0301, verificata attraverso tipo, frequenza e severità degli Eventi Avversi, e correlazione al farmaco sperimentale, interruzione dovuta agli eventi avversi, e cambiamenti clinicamente significativi negli Elettrogrammi, segni vitali, e/o risultati di laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Week 208 and 4 weeks postdose
    Fino alla settimana 208 e per 4 settimane dopo la somministrazione
    E.5.2Secondary end point(s)
    Secondary endpoints are not included in this study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 No
    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 No
    E.8.1.6Cross over Yes
    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 concerned15
    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 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
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Korea, Republic of
    Latvia
    Netherlands
    New Zealand
    Norway
    Poland
    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.
    Il termine della sperimentazione è definito come la data dell’ultima visita dell’ultimo soggetto per completare il follow-up post-trattamento oppure la data di ricezione degli ultimi dati dell’ultimo soggetto che sono necessari per l’analisi primaria e/o esplorativa, come specificato in precedenza nel protocollo, a seconda di quale è più recente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 1343
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 71
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 452
    F.4.2.2In the whole clinical trial 1414
    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 Decision2016-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-10-19
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