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    Summary
    EudraCT Number:2014-003896-41
    Sponsor's Protocol Code Number:D5181C00001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-003896-41
    A.3Full title of the trial
    A Phase 2a, Randomized, Placebo-controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects with Primary Sjogren’s Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MedImmune Sjogren's Syndrome Study
    A.4.1Sponsor's protocol code numberD5181C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02334306
    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 SponsorMedImmune, LLC
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post codeMD 20878
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrialtransparency@astrazeneca.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 nameAMG 557/MEDI5872
    D.3.2Product code AMG 557/MEDI5872
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 557/MEDI5872
    D.3.9.2Current sponsor codeAMG 557/MEDI5872
    D.3.9.4EV Substance CodeSUB74523
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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) 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 typemonoclonal antibody (IgG2k)
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sjogren’s Syndrome
    E.1.1.1Medical condition in easily understood language
    Primary Sjogren's syndrome is an autoimmune disease. The most common symptoms are mild-to-severe dryness of the eyes and mouth with no other condition that might be contributing to these symptoms.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10042846
    E.1.2Term Syndrome Sjogren's
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the effect of AMG 557/MEDI5872 compared to placebo in reducing objective measures of overall disease activity in subjects with primary Sjogren’s syndrome (pSS).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To evaluate the effect of AMG 557/MEDI5872 compared to placebo on peripheral blood and salivary gland biomarkers in subjects with pSS.
    • To evaluate the safety and tolerability of multiple subcutaneous (SC) doses of AMG 557/MEDI5872 in subjects with pSS.
    • To evaluate the effect of AMG 557/MEDI5872 compared to placebo in reducing subjective measures of overall disease activity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 through 75 years at the time of signing the informed consent form (ICF).
    ……
    6. Fulfill American-European Consensus Group (AECG) criteria for pSS.
    7. European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ESSDAI) score ≥ 6.
    8. Positive anti-SS-A and/or anti-SS-B autoantibodies AND at least one of the following laboratory abnormalities:
    a. Immunoglobulin G (IgG) > 13 g/L
    b. Rheumatoid factor (RF) level > upper limit of normal (ULN)
    c. Positive test for cryoglobulins
    9. Willingness to undergo protocol-required minor salivary gland biopsies.
    10. Meet all of the following tuberculosis (TB) criteria (see protocol)
    11. Immunization up to date as determined by local standard of care.

    For a detailed list of inclusion criteria, please refer to the protocol.

    E.4Principal exclusion criteria
    ..
    3. Previous treatment with AMG 557/MEDI5872.
    4. Evidence of signs or symptoms of a viral, bacterial, or systemic fungal infection within 2 weeks (14 days) prior to randomization (Day 1) according to the assessment of the investigator; any infection requiring intravenous (IV) antibiotic or antiviral treatment within 8 weeks of randomization (Day 1); history of herpes zoster within 3 months prior to randomization (Day 1).
    ...
    6. Evidence of significant renal insufficiency, defined by estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73m2.
    7. Positive test at screening for either hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
    ...
    16. Prior administration of any of the following:
    a. Belimumab in the past 6 months prior to randomization (Day 1);
    b. Rituximab in the past 12 months or CD19+ B cells < 5/μL if rituximab treatment was more than 12 months prior to randomization (Day 1);
    c. Abatacept in the past 6 months prior to randomization (Day 1);
    d. Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab) in the past 3 months prior to randomization (Day 1);
    e. Tocilizumab in the past 3 months prior to randomization (Day 1);
    f. Cyclophosphamide (or any other alkylating agent) in the past 6 months prior to randomization (Day 1); cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil, azathioprine, or leflunomide in the past 3 months prior to randomization (Day 1).
    ...
    20. Receiving any of the following:
    a. Corticosteroids:
    i. > 10 mg/day oral prednisone (or equivalent);
    ii. Any change or initiation of new dose of oral corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1);
    iii. Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1);
    iv. Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to signing the ICF through randomization (Day 1);
    b. Antimalarials: any increase or initiation of new dose of antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) within 12 weeks prior to signing the ICF through randomization (Day 1).
    c. Methotrexate:
    i. > 20 mg/week methotrexate;
    ii. Any change or initiation of new dose of methotrexate within 4 weeks prior to signing the ICF through randomization (Day 1);
    iii. Any change in route of administration.
    d. Any increase or initiation of new dose of regularly scheduled nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to signing the ICF through randomization (Day 1).
    e. Any increase or initiation of new doses of cevimeline or pilocarpine and cyclosporine eye drops (Restasis) within 2 weeks prior to signing the ICF through randomization (Day 1).

    For a detailed list of exclusion criteria, please refer to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the change in the European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ESSDAI) score from Baseline to Day 99.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 99
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are:
    • Biomarkers:
    Outcomes in peripheral blood
    ◦ Change in plasma cell (PC) levels (including plasma blast [PB] levels) from Baseline to Day 99
    ◦ Change in T follicular helper (TFH) levels from Baseline to Day 99
    Outcomes in minor salivary gland tissue
    ◦ Change in PC levels from Baseline to Day 99
    ◦ Change in TFH levels from Baseline to Day 99
    Focus score
    ◦ Change in focus score from Baseline to Day 99
    • Safety and tolerability of multiple SC doses of AMG 557/MEDI5872 as measured by the incidence of treatment-emergent adverse events, treatment-emergent serious adverse events, adverse events of special interest, and laboratory abnormalities
    • Change in European League Against Rheumatism Sjogren’s Syndrome Patient Reported Index score from Baseline to Day 99
    Exploratory endpoints of the study are provided in the protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 99; safety each visit
    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 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    France
    Sweden
    United Kingdom
    United States
    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
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 42
    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 Decision2015-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-13
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