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    Summary
    EudraCT Number:2010-019157-17
    Sponsor's Protocol Code Number:OTX113390
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-019157-17
    A.3Full title of the trial
    Evaluation of the safety and tolerability of re-dosing with intravenous (IV)otelixizumab in adult subjects with newly
    diagnosed type 1 diabetes mellitus.
    A.4.1Sponsor's protocol code numberOTX113390
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research and Development LTD
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 GSK2136525
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNOtelixizumab
    D.3.9.1CAS number 881191-44-2
    D.3.9.2Current sponsor codeGSK2136525
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.2
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeMonoclonal Antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autoimmune new onset type 1 diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety, tolerability, and immunogenicity of re-dosing at 6 months
    with an 8-consecutive day series of otelixizumab intravenous (IV) infusions in
    adult subjects with newly diagnosed T1DM.
    E.2.2Secondary objectives of the trial
    To characterise the PK and PD effects following re-dosing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged 18 to 45 years, inclusive, at the time of anticipated first dose of
    study drug.
    2. A female subject is eligible to participate if she is of:
    a. Non-childbearing potential defined as:
    i. pre-menopausal females with a documented tubal ligation or
    hysterectomy; or
    ii. post-menopausal defined as 12 months of spontaneous
    amenorrhoea [in questionable cases a blood sample with
    simultaneous follicle stimulating hormone (FSH) > 40 mIU/ml and
    estradiol <40pg/ml (<140 pmol/L) is confirmatory].
    b. Child-bearing potential and agrees to use one of the contraception methods
    listed below:
    􀂙 abstinence
    􀂙 oral contraceptive, either combined or progestogen alone
    􀂙 injectable progestogen
    􀂙 implants of levonorgestrel
    􀂙 oestrogenic vaginal ring
    􀂙 percutaneous contraceptive patches
    􀂙 intrauterine device (IUD) or intrauterine system (IUS) that has a
    failure rate of <1% per year as stated in the product label
    􀂙 male partner sterilisation (vasectomy with documentation of
    azoospermia) prior to the female subject’s entry into the study, and this
    male is the sole partner for the subject
    􀂙 double barrier method: condom and an occlusive cap (diaphragm or
    cervical/vault caps) with a vaginal spermicidal agent
    (foam/gel/film/cream/suppository)
    Adequate contraception must be used from the beginning of the screening period or
    at least 14 days prior to dosing until at least 60 days after the last dose of the second
    treatment course of study drug.
    Male subjects with partners of childbearing potential must use a barrier method of
    contraception from the day of the first dose of study drug until at least 60 days after
    the last dose or they must have had a vasectomy. This applies to both dosing
    periods.
    3. a. Diagnosis of diabetes mellitus according to ADA and WHO criteria (see
    Appendix 1), with an interval of ≤ 90 days between the initial diagnosis and the first
    dose of study drug. Documentation of the diagnosis of DM, including the date of
    diagnosis, must be obtained from the diagnosing physician.
    b. History and clinical course consistent with type 1a (autoimmune) DM.

    Please refer to the protocol
    E.4Principal exclusion criteria
    1. Pregnant, breastfeeding, or planning to become pregnant from the beginning of the screening period or at least 14 days prior to initial dosing until at least 60 days after the last dose of the second treatment course of study drug.
    2. Current or prior malignancy, other than non-melanoma skin cancer (subject must
    have had fewer than 5 occurrences of non-melanoma skin cancer, and the last
    occurrence must not be within 3 months of study entry).
    3. Clinically significant abnormal laboratory values during the Screening period, other
    than those due to T1DM. Permitted ranges for selected laboratory values are shown
    in Table 2. A clinically significant abnormal value will not result in exclusion if,
    upon re-test, the abnormality is resolved or becomes clinically insignificant.
    4. Significant and/or active disease in any body system likely to increase the risk to the subject or interfere with the subject’s participation in or completion of the study.
    Examples of significant diseases include, but are not limited to, coronary artery
    disease, congestive heart failure, uncontrolled hypertension, renal failure,
    emphysema, history of bleeding peptic ulcers, history of seizure(s), addiction to
    illicit drugs, and alcohol abuse.
    5. Current or chronic history of liver disease, known hepatic or biliary abnormalities
    (with the exception of Gilbert’s syndrome or asymptomatic gallstones), presence of
    hepatitis B surface antigen (HBsAg), positive hepatitis C test result within 3 months
    of screening
    6. Significant systemic infection during the 6 weeks before the first dose of study drug
    (e.g., infection requiring hospitalisation, major surgery, or IV antibiotics to resolve;
    other infections, e.g., bronchitis, sinusitis, localised cellulitis, candidiasis, or urinary
    tract infections, must be assessed on a case-by-case basis by the investigator
    regarding whether they are serious enough to warrant exclusion).
    7. History of current or past active tuberculosis infection and or latent tuberculosis
    infection (as per Centers for Disease Control [CDC] Guidelines) [Center for Disease
    Control and Prevention, 1995]. This eligibility criterion can be met with a negative
    purified protein derivative (PPD) test result during Screening or a documented
    negative result within 6 months prior to dosing. In specific circumstances (e.g., the
    subject has a history of BCG [Bacille Calmette-Guérin] vaccination, a positive
    Screening PPD test that is believed to be a false positive result, or the investigator
    does not believe it is safe to perform a Screening PPD test), this criterion may be met
    by other means following a diagnostic algorithm determined in consultation with the
    medical monitor. This diagnostic algorithm will include:
    a) A complete clinical evaluation, including, at a minimum, BCG vaccination
    history, tuberculosis exposure history, and clinical signs and symptoms suggestive
    of tuberculosis infection; and
    b) In consultation with the medical monitor, further testing to rule out a false
    positive Screening PPD test or to rule out latent tuberculosis in place of a
    Screening PPD test may include IFNγ testing (e.g., QuantiFERON-TB assay)
    and/or chest X-ray.
    8. A positive test for human immunodeficiency virus (HIV) antibody or risk factors
    which predispose subject to HIV infection.
    9. EBV viral load of ≥10,000 copies per 106 peripheral blood mononuclear cells
    (PBMCs) as determined by quantitative polymerase chain reaction (qPCR). If there
    is any clinical suspicion that a subject who is EBV seronegative and with EBV PCR
    <10,000 copies per 106 PBMCs has symptoms consistent with infectious
    mononucleosis prior to administration of study drug, then a monospot test result
    must be negative before the subject can be dosed.


    Please refer to the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability:
    • Adverse Events (AEs).
    • Change from baseline and number of subjects outside the normal range for
    blood pressure, respiration rate, heart rate and temperature.
    • Change from baseline in clinical chemistry and haematology parameters.
    • Epstein-Barr Virus viral load
    • Change in total lymphocyte, CD4+ and CD8+ T-cell counts (also a
    secondary pharmacodynamic endpoint, see below).
    • Immunogenicity - Serum levels of anti-otelixizumab binding antibodies.
    Where binding antibodies are detected, proportion which are antiotelixizumab
    neutralising antibodies.
    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 No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last subject last visit
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 8
    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)
    Subjects will be invited to participate in a follow-on study for a further 24 months to
    assess safety, however, additional treatment with otelixizumab will not be provided.
    Subjects will continue to receive insulin therapy as prescribed by their health care
    provider.
    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 Decision2010-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-14
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