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    Summary
    EudraCT Number:2015-000595-10
    Sponsor's Protocol Code Number:D5240C00001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-15
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-000595-10
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Moderate-to-Severe Atopic Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults with Atopic Dermatitis
    A.4.1Sponsor's protocol code numberD5240C00001
    A.5.4Other Identifiers
    Name:IND Number:125565
    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 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 supportMedImmune Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune Ltd
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressMilstein Building, Granta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailClinicalTrialEnquiries@Medimmune.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 nameMEDI9929 / AMG 157
    D.3.2Product code MEDI9929 / AMG 157
    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 INNPending
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929/AMG157
    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 Yes
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Eczema
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    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 effect of MEDI9929 compared with placebo in adult subjects with moderate to severe AD, assessed using the change from baseline in EASI at Week 12.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of MEDI9929 on the efficacy measure of IGA
    2. To evaluate the effect of MEDI9929 on the efficacy measure of SCORAD
    3. To evaluate the effect of MEDI9929 on patient-reported outcome (PRO) measures of pruritus assessed
    using a NRS and 5-D Pruritus Scale
    4. To evaluate the safety and tolerability of MEDI9929
    5. To characterize the pharmacokinetics (PK) and immunogenicity of MEDI9929
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent and any locally required authorization (eg, Health Insurance
    Portability and Accountability Act [HIPAA] in the USA, European Union [EU] Data
    Privacy Directive in the EU) obtained from the subject prior to performing any protocolrelated
    procedures, including screening evaluations.
    2. Age 18-75 years inclusive at the time of Screening
    3. Current disease state meeting the Hanifin and Rajka, 1980 criteria for AD (see Appendix 5)
    4. Atopic dermatitis that affects ≥ 10% body surface area at Visit 1 (Screening), as assessed
    by EASI
    5. A IGA score of ≥ 3 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
    6. An EASI score of ≥ 12 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
    7. A SCORAD of ≥ 20 at Visit 1 (Screening)
    8. No clinically significant abnormality on the basis of medical/medication history or
    physical examination
    9. If on allergen-specific immunotherapy, subjects must be on a maintenance dose and
    schedule for ≥ 1 month prior to Visit 1 (Screening). Allergen-specific immunotherapy
    refers to subcutaneous immunotherapy to aeroallergens and/or venom (Hymenoptera) as
    well as sublingual immunotherapy to aeroallergens.
    10. Able and willing to comply with the requirements of the protocol
    11. Females of childbearing potential who are sexually active with a nonsterilized male
    partner must use highly effective contraception from enrollment (after written informed
    consent is obtained) and must agree to continue using such precautions through to the end
    of the study; cessation of birth control after this point should be discussed with a
    responsible physician. Periodic abstinence, the rhythm method, and the withdrawal
    method are not acceptable methods of birth control. Females of childbearing potential are
    defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral
    oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). A highly effective method of
    contraception is defined as one that results in a low failure rate (ie, less than 1% per year)
    when used consistently and correctly (Table 4.1.2-1).
    E.4Principal exclusion criteria
    1. Active dermatologic conditions, which may confound the diagnosis of AD or would
    interfere with assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous
    lymphoma, ichthyosis, or psoriasis
    2. Known active allergic or irritant contact dermatitis
    3. History of a clinically significant infection within 4 weeks prior to Visit 3 (Week 0,
    Day 1) which, in the opinion of the investigator or medical monitor, may compromise the
    safety of the subject in the study, interfere with evaluation of the investigational product,
    or reduce the subject’s ability to participate in the study. Clinically significant infections
    are defined as:
    ◦ A systemic infection or
    ◦ A serious skin infection requiring parenteral antibiotics, antiviral, or antifungal
    medication.
    4. Diagnosis of a helminth parasitic infection within 6 months prior to screening that has not
    been treated with, or has failed to respond to standard of care therapy
    5. History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix
    treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to
    Visit 1 (Screening)
    6. History of chronic alcohol or drug abuse within 12 months prior to screening, or any
    condition associated with poor compliance as judged by the investigator
    7. Pregnant or breastfeeding women or pregnancy planned within the next 6 months from
    last dose
    8. Use of tanning beds or phototherapy within 8 weeks of Visit 3 (Week 0, Day 1)
    9. Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives
    prior to Visit 3 (Week 0, Day 1), whichever is longer
    10. Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to
    Visit 3 (Week 0, Day 1), whichever is longer
    11. Treatment with the following medications within the last 4 weeks prior to Visit 3
    (Week 0, Day 1):
    a. Systemic immunosuppressive/immunomodulating drugs (eg, methotrexate,
    cyclosporine, azathioprine, mycophenolate mofetil, tacrolimus, interferon )
    b. Immunoglobulin and/or blood products
    c. Systemic corticosteroids (topical, inhaled, or intranasal delivery are permitted)
    d. Topical calcineurin inhibitor use
    12. Subjects who have received a live or attenuated vaccine within 4 weeks prior to Visit 3
    (Week 0, Day 1). Receipt of inactive/killed vaccinations (eg, inactive influenza) is
    allowed provided they are not administered within 1 week before/after any study visit.
    13. Receipt of the Th2 cytokine inhibitor suplatast within 15 days prior to Visit 1 (Screening)
    is allowed
    14. Known history of allergy or reaction to any component of the investigational product
    formulation
    15. History of anaphylaxis following any biologic therapy
    16. Subjects who are intolerant or contraindicated to use study-mandated TCS for lesional
    skin
    17. Any clinically relevant abnormal findings in physical examination ECG, vital signs,
    hematology, clinical chemistry, or urinalysis during screening, which in the opinion of
    the investigator or medical monitor may compromise the safety of the subject in the study
    or interfere with evaluation of the investigational product or reduce the subject’s ability
    to participate in the study
    18. Evidence of active liver disease, including jaundice or aspartate transaminase (AST),
    alanine transaminase (ALT), or alkaline phosphatase greater than twice the upper limit of
    normal (ULN)
    19. Subjects who have a positive QuantiFERON-tuberculosis Gold (QFT-G) test for
    tuberculosis (TB) during screening or have evidence of active TB, either treated or
    untreated. Subjects with an indeterminate QFT-G result may be enrolled if they have
    ALL of the following:
    a. No symptoms of TB: productive, prolonged cough (> 3 weeks); coughing up blood;
    fever; night sweats; unexplained appetite loss; unintentional weight lossb. No known exposure to a case of active TB
    c. No evidence of active TB on chest radiograph within 3 months prior to Visit 3
    (Week 0, Day 1)
    d. Subjects with an indeterminate QFT-G result will have repeat QFT-G testing at
    Visit 9 (Week 12)
    20. Positive hepatitis B surface antigen or hepatitis C virus antibody serology.
    21. A positive human immunodeficiency virus (HIV) test at screening or subject taking
    antiretroviral medications, as determined by medical history and/or subject's verbal report
    22. Concurrent enrollment in another clinical study where the subject is receiving an
    investigational product
    23. Employee of the clinical study site or any other individuals directly involved with the
    conduct of the study, or immediate family members of such individuals
    24. Individuals who are legally institutionalized
    25. Major surgery within 8 weeks prior to Visit 1 (Screening), or planned in-patient surgery
    or hospitalization during the study period
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects achieving a ≥ 50% reduction from baseline in the EASI score
    (EASI 50) at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    1. The proportion of subjects achieving both IGA 0 (clear) or 1 (almost clear) and a
    reduction from baseline of ≥ 2 points.
    2. Change from baseline in EASI
    3. The proportion of subjects achieving a ≥ 75% reduction from baseline in the EASI score
    (EASI 75).
    4. Change from baseline in SCORAD
    5. The proportion of subjects achieving a ≥ 50% reduction from baseline in SCORAD
    (SCORAD 50).
    6. The proportion of subjects achieving a ≥ 75% reductionfrom baseline in SCORAD
    7. The proportion of subjects achieving EASI 50
    8. Change from baseline in pruritus NRS
    9. Change from baseline in 5-D Pruritus score
    10. Safety and tolerability of MEDI9929 including adverse events (AEs), serious adverse events (SAEs),
    vital signs, laboratory parameters, electrocardiograms (ECGs), and physical examinations
    11. PK profile and immunogenicity of MEDI9929
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be measured up to Week 12 for on-therapy effects and time points beyond end of treatment for off-therapy effects.
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Canada
    Germany
    Hungary
    New Zealand
    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
    last visit of the last subject undergoing the trial
    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 months1
    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 months1
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 100
    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 Decision2015-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-14
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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