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    Summary
    EudraCT Number:2008-007459-28
    Sponsor's Protocol Code Number:H9B-MC-BCDJ(b)
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-18
    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 ConcernedFinland - Fimea
    A.2EudraCT number2008-007459-28
    A.3Full title of the trial
    Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis
    A.4.1Sponsor's protocol code numberH9B-MC-BCDJ(b)
    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 SponsorEli Lilly and Company
    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 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.3.1Product nameLY2127399
    D.3.2Product code LY2127399
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNN/a
    D.3.9.1CAS number N/a
    D.3.9.2Current sponsor codeLY2127399
    D.3.9.3Other descriptive nameAnti LP40 antibody, subclass IgG4 LA294
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4 to 120
    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) Yes
    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 No
    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
    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
    Relapsing-Remitting Multiple Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective
    The primary objective of this study is to test the hypothesis that subjects with RRMS in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)-enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group.
    E.2.2Secondary objectives of the trial
    To determine or evaluate:
    Safety/tolerability of LY2127399 (LY) compared to placebo.
    Whether Total:
    number of Gd-enhancing MRI lesions,
    number of new Gd-enhancing MRI lesions,
    number of new or newly enlarging T2-weighted MRI lesions, and
    volume of T2-weighted MRI lesions are statistically significantly less in ≥1 LY group compared to placebo over the 48-week duration of the study.
    Whether the time to first relapse is statistically significantly longer in 1 or more LY groups compared to placebo.
    Whether the proportion of relapse-free subjects is greater, and whether there is a
    smaller annualized relapse rate over 24 and 48 weeks in ≥1 LY group compared to placebo.
    Proportion of subjects with anti-LY antibodies at the end of the study.
    PD of selected peripheral B cell subsets following administration of LY compared to placebo.
    Serum PK of LY after multiple doses.
    Effect of treatment with LY compared to placebo on EDSS, MSFC, VAS of Wellbeing, SF-36, and QIDS-SR16.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Sample Banking Addendum H9B-MC-BCDJ(1)
    Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis;
    T
    he objective of Study H9B-MC-BCDJ (BCDJ) is to evaluate the safety and efficacy of
    LY2127399, a fully human antibody that neutralizes B cell activating factor (BAFF) of
    the tissue necrotic factor (TNF) family, when administered to subjects with multiple
    sclerosis (MS). The objective of this protocol addendum is to collect whole blood,
    serum, and plasma samples from subjects participating in Study BCDJ. The data derived from this protocol addendum will permit future genetic and biochemical analyses that have the potential to provide predictors or correlative biomarkers of response to LY2127399. Further, these data, derived from well-characterized MS patients who have participated in trials of biologic therapies, will help in the future development of tailored therapeutic approaches to this disease.
    E.3Principal inclusion criteria
    Inclusion Criteria
    Subjects are eligible to be included in the study only if they meet all of the following
    criteria:
    [1] Qualify as having RRMS prior to Visit 2, based on the disease diagnostic criteria as defined by revised McDonald Criteria (Polman et al. 2005). (Search revised McDonald Criteria at http:// www.nationalmssociety.org).
    [2] A Kurtzke EDSS (Kurtzke 1983) score of 0 through 5.0. This would include subjects who are ambulatory.
    [3] Have at least 1 documented clinical relapse within 12 months prior to Visit 2; OR show evidence of Gd-enhancing lesion(s) of the brain or spine by MRI performed within 12 months prior to Visit 2.[4] Are 18 to 64 years of age, inclusive.
    [5] Inclusion criterion [5] only applies to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause). These females must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate (<1% per year) during the study or for at least 8 weeks after the last injection of study drug, which ever is longer
    (for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence).
    E.4Principal exclusion criteria
    •Have MS categorized as primary progressive, secondary progressive or progressive relapsing.
    •Have had a relapse within 30 days and/or have not stabilized from a previous relapse and/or have had systemic corticosteroid therapy within 30 days prior to randomization.
    •Have greater than 15 Gd-enhancing lesions of the brain by MRI performed between Visits 1 and 2.
    •Have received any B cell biological therapies (such as rituximab, ocrelizumab, ofatumumab, belimumab, atacicept, or BR3-Fc); or have had treatment with cyclophosphamide, mitoxantrone, mycophenolate mofetil, or cladribine within the previous year; interferon beta or glatiramer acetate within 3 months prior to randomization; or cyclosporine, azathioprine, methotrexate, or intravenous immune globulin, plasmapheresis or cytapheresis within 6 months prior to randomization; or other biological agent/monoclonal antibody within 3 months prior to randomization; or a non-biologic drug or device that has not received regulatory approval for any indication within 30 days prior to the time of study entry.
    •Have had a live vaccination within 3 months before randomization, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical trial within 3 months prior to randomization.
    •Have had elective surgery within 2 weeks prior to randomization or are scheduled to have 1 during the study.
    •Are immunocompromised; or have evidence of active infection (such as viral hepatitis and/or positive testing for tuberculosis or human immunodeficiency virus [HIV]); or have had a recent serious systemic infection. However, subjects with a history of active or latent TB who have documented evidence of adequate treatment may be enrolled in the study. Subjects who have had household contact with a person with active TB are excluded, unless appropriate and documented prophylaxis for TB was given..
    •Have history of or current lymphoproliferative disease, malignant disease (except for resolved basal or squamous carcinoma); have significant allergies to humanized monoclonal antibodies or clinically significant or severe drug allergies/hypersensitivity; or have serious or unstable/uncontrolled illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic (other than MS), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator’s opinion, would place the subject at increased safety risk and/or could interfere with the analyses of safety and efficacy in this study.
    •Have uncontrolled arterial hypertension characterized by a systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.
    •Have known hypogammaglobulinemia or a serum IgG, IgM, or IgA concentration less than the lower limit of the reference range.
    •Have hematology and/or serum chemistry laboratory test values outside the reference range for the population or investigative site that are considered clinically significant; and/or have specific abnormalities of white blood cells <3 G/L, lymphocytes <0.8 G.L, polymorphonuclear leukocytes <1.5 G/L, platelets <100 G/L, aspartate transaminase (AST) or alanine transaminase (ALT) >2 x upper limit of normal (ULN), bilirubin >1.5 x ULN, abnormal thyroid function, serum creatinine of >177 µmol/L, or a calculated creatinine clearance <60 mL/min.
    •Have contraindications for MRI: pacemakers or other containdicated implanted metal devices, allergy to gadolinium, of claustrophobia that cannot be managed.
    Have donated blood of more than 500 mL within the last month.
    E.5 End points
    E.5.1Primary end point(s)
    is to test the hypothesis that subjects with relapsing remitting-multiple sclerosis (RRMS) in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)-enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    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
    Last Patient Last Vist
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 245
    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 Decision2009-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-13
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