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    Summary
    EudraCT Number:2015-001963-37
    Sponsor's Protocol Code Number:GED-0301-CD-004
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-04-13
    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 ConcernedBulgarian Drug 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
    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
    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
    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 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+18882601599
    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
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease (an Inflammatory Bowel Disease)
    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 100000016693
    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
    E.2.2Secondary objectives of the trial
    Secondary Objectives (Adolescent Subjects):
    - evaluate the efficacy of GED-0301 on clinical activity
    - evaluate long-term endoscopic outcomes of GED-0301
    - evaluate the long-term changes in linear growth in response to GED-
    0301
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Adult Subjects:
    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 the Week 12 Visit in the core
    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 beginning at the
    Week 12 Visit 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).FCBP must
    either practice true abstinence from heterosexual contact or use one of
    the options while on IP and for at least 28 days after taking last dose of
    IP.
    Inclusion Criteria for Adolescent Subjects:
    1. male or female, 12 to 17 years of age at the time of assent/informed
    consent in core GED-0301-CD-003 study and must affirmatively
    agree to participate in this study by signing an assent with a
    parent/legal guardian who can understand and voluntarily sign an ICF.
    Adolescent subjects who turn 18 by the screening visit for GED-0301-CD-
    004 study must also understand and voluntarily sign an ICF prior to any
    study-related assessments/procedures being conducted.
    2. able to swallow the IP tablets.
    3. willing and able to adhere to study visit schedule and protocol
    requirements, and a parent or legal guardian willing to supervise
    adherence to protocol requirements.
    4. must have completed through the Week 12 Visit in Study GED-0301-
    CD-003.
    5. Females of childbearing potential (FCBP)5 must have a negative
    pregnancy test at screening and enrollment (Visits 1 and 2). FCBP must
    either practice true abstinence from heterosexual contact or use one of
    the approved contraceptive options while on IP and for at least 28 days
    after taking the last dose of IP.
    E.4Principal exclusion criteria
    1. Subject had experienced a serious adverse event related to the IP
    while participating in the core Phase 3 GED-0301 study.
    2. Subject has any continuing serious medical condition, laboratory
    abnormality, or psychiatric illness that occurred while participating in
    the core 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 while, or after participating in the core Phase 3
    GED-0301 study.
    5. Subject diagnosed with colorectal cancer or confirmed diagnosis of
    colorectal dysplasia (with the exception of adenomatous colonic polyps
    that have been completely resected) while participating in the core
    Phase 3 GED-0301 study.
    6. newly diagnosed malignancy while participating in the previous Phase
    3 GED-0301 study.
    7. pregnant or breastfeeding.
    8. Subject has been newly diagnosed with substance abuse.
    9. New condition that may put subject at risk or confound the ability to
    interpret data from the study.
    9. known hypersensitivity to oligonucleotides, GED-0301 or any
    ingredient in the IP.
    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
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Week 208 and 4 weeks postdose
    E.5.2Secondary end point(s)
    Secondary endpoints are not included in this study.
    Secondary endpoints for Adolescents subjects from GED-0301-CD-003:
    - The proportion of subjects with clinical remissiona at Week 40.
    - The proportion of subjects with endoscopic remission defined as SESCD
    ≤ 2 at Week 40
    - The proportion of subjects who have clinical remissiona, defined as a
    PCDAI ≤ 10 points at Week 40.
    - The change from baseline (GED-0301-CD-003) in weight, height, body
    mass index (BMI), and height velocity z-scores (adjusted for
    chronological age) at Week 40
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different dose or regimen of the study treatment
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA371
    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
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Korea, Republic of
    Latvia
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Norway
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Sweden
    Switzerland
    Taiwan
    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.
    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 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1243
    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 state70
    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
    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 Decision2016-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-01-04
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