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    Summary
    EudraCT Number:2019-003304-12
    Sponsor's Protocol Code Number:D9182C00001
    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:2019-12-06
    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 number2019-003304-12
    A.3Full title of the trial
    A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 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
    A Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects with Moderate-to-severe Atopic Dermatitis
    A.3.2Name or abbreviated title of the trial where available
    FRONTIER-AD
    A.4.1Sponsor's protocol code numberD9182C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@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 nameMEDI3506
    D.3.2Product code MEDI3506
    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.3.9.2Current sponsor codeMEDI3506
    D.3.9.3Other descriptive namehuman immunoglobulin (Ig) G1 monoclonal antibody (mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Atopic Dermatitis
    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 21.1
    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
    Efficacy
    To assess the effects of MEDI3506 compared with placebo on Atopic Dermatitis (AD) disease severity, in adult subjects with moderate to severe AD.
    E.2.2Secondary objectives of the trial
    Efficacy
    To further assess the effects of MEDI3506 compared with placebo on AD disease severity and symptoms, in adult subjects with moderate to severe AD.

    Safety
    To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate to severe AD

    PK
    To evaluate the PK of MEDI3506 in adult subjects with moderate to severe AD.

    Immunogenicity
    To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate to severe AD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria:

    If any criterion cannot be fully assessed at screening Visit 1 (eg, due to awaiting information from the subject's usual physician), the criterion must be fully assessed prior to randomization.

    1 Written informed consent and any locally required authorization (eg, data privacy) prior to performing any protocol-related procedure, including screening.
    2 Age 18 to 65 years inclusive at the time of consent.
    3 Body mass index between 19.0 and 40.0 kg/m2 inclusive at screening Visit 1.
    4 Documented history of chronic AD as defined using Hanifin and Rajka's criteria, for at least 1 year prior to screening Visit 1.
    5 Meets at minimum 1 of the criteria, as follows:
    (a) A documented history, within the 6 months prior to screening Visit 1, of an IGA score of ≥ 3, despite treatment with daily, medium or high potency TCSs in the presence or absence of TCIs, applied for ≥ 4 weeks or for the maximum duration recommended by the product prescribing information, whichever is shorter, or
    (b) A documented history, within the 6 months prior to screening Visit 1, of requiring intermittent or continuous systemic corticosteroid therapy,
    (c) Subject intolerance to treatment with topical medications for AD, or
    (d) Topical medications are otherwise medically inadvisable (eg, due to important side effects or safety risks that outweigh the potential treatment benefits), as assessed by the investigator or by the physician who treats the subject's AD.
    6 Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all subject facing questionnaires used at site, and use electronic devices.
    7 AD that affects ≥ 10% of the body surface area (BSA) at both Visit 1 and Visit 3 (Day 1), as assessed by EASI.
    8 An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
    9 An IGA score of ≥ 3 at both Visit 1 and Visit 3 (Day 1).
    10 Female subjects, regardless of childbearing potential, must have
    negative pregnancy tests
    both at screening Visit 1 (serum pregnancy test) and pre-dose of
    investigational product at Visit 3 (Day 1; urine pregnancy test).
    11 Female subjects of childbearing potential who are sexually active
    with a male partner
    must agree to use a highly effective method of contraception from
    screening until the end
    of the follow-up period at Visit 12 (Week 24) of the study.
    - In countries where spermicide is available, it is strongly recommended
    for the male
    partner of a female subject of childbearing potential to also use male
    condom plus spermicide throughout this period.
    - In countries where spermicide is not available, it is strongly
    recommended for the male partner of a female subject of childbearing
    potential to also use male condom throughout this period.
    12 Female subjects of childbearing potential who are sexually active
    with a male partner
    must agree to use a highly effective method of contraception.
    - In countries where spermicide is available, male subjects who are
    sexually active
    with a female partner of childbearing potential must agree to use a male
    condom with
    spermicide and another highly effective method of contraception during
    the treatment
    and follow-up periods from Visit 3 (Day 1) through to Visit 12 (Week 24)
    of the study.
    - In countries where spermicide is not available, male subjects who are
    sexually active
    with a female partner of childbearing potential must agree to use a male
    condom and
    another highly effective method of contraception during the treatment
    and follow-up
    periods from Visit 3 (Day 1) through to Visit 12 (Week 24) of the study.
    13 As confirmed from electronic diary (eDiary) entries, the subject has applied a stable dose
    of topical emollient (moisturizer) twice daily for ≥ 7 consecutive days
    immediately before
    baseline at Visit 3 (Day 1) with a minimum of (85%) compliance.
    E.4Principal exclusion criteria
    1 Subjects with a recent history of or who have a positive test for infective hepatitis, HIV or unexplained jaundice, or subjects who have been treated for hepatitis B, hepatitis C, or HIV. For the hepatitis B testing (hepatitis B surface antigen [HBsAg], hepatitis B surface antibody [anti-HBs], and hepatitis B core antibody [anti-HBc]), any of the following would exclude the subject from the study:
    (a) Subjects positive for HBsAg.
    (b) Subjects positive for anti-HBc.
    Subjects with a history of hepatitis B vaccination without a history of hepatitis B are permitted.
    2 Evidence of active or latent tuberculosis (TB).
    3 N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) level greater than the upper limit of the laboratory reference range at screening Visit 1.
    4 A left ventricular ejection fraction < 45% measured by echocardiogram during screening, between the time of signing informed consent and prior to randomization.
    5 A family history of heart failure defined as either of the following:
    (a) ≥ 2 first degree relatives with clinically significant heart failure, or
    (b) ≥ 1 first degree relative with heart failure known to be heritable (eg, hypertrophic cardiomyopathy), unless inheritance is excluded by genetic testing.
    6 Concurrent enrollment in another clinical study involving an investigational product.
    7 Participated in a clinical study for a medical device within 3 months, prior to screening at Visit 1.
    8 Subject is a participating investigator, sub-investigator, study
    coordinator, or employee of the participating site, or is a first-degree
    relative of the aforementioned.
    9 Subject has been committed to an institution by virtue of an order
    issued either by the courts or by a public authority.
    10 Any active medical or psychiatric condition, or other reason, prior to
    randomization, that, in the opinion of the investigator, would interfere
    with evaluation of the investigational product or interpretation of
    subject safety or study results.
    (a) Significant risk factors for COVID-19, such that study participation is
    not in the best interests of the subject in the opinion of the investigator.
    (b) Known or clinically suspected COVID-19 infection within 3 months of
    randomization.
    11 Any other clinically relevant abnormal findings from physical
    examination (including vital signs and electrocardiogram [ECG]) or from
    safety laboratory analysis (including hematology, coagulation, serum
    chemistry, or urinalysis) between informed consent and randomization,
    that in the opinion of the investigator or medical monitor might
    compromise the safety of the subject in the study or interfere with
    evaluation of the investigational product.
    12 A known history of severe reaction to any medication including
    biologic agents or human gamma globulin therapy.
    13 Active dermatologic conditions that might confound the diagnosis of
    AD or would interfere with the assessment of the skin, for example
    scabies, seborrheic dermatitis, cutaneous lymphoma, or psoriasis.
    14 Known active allergic or irritant contact dermatitis.
    15 Known history of allergy or reaction to any component of the investigational product formulation,including hereditary fructose
    intolerance.
    16 Pregnancy or intention to become pregnant during the course of the
    study, breastfeeding, or unwillingness to use a highly effective method
    of contraception throughout the study in female subjects of childbearing
    potential.
    17 History of, or a reason to believe a subject has a history of, drug or
    alcohol abuse within the past 2 years prior to screening.
    18 Major surgery within 8 weeks prior to screening at Visit 1, or planned
    inpatient surgery or hospitalization during the TCS/TCI wash out,
    treatment, or follow-up periods.
    19 Donation of blood or blood products in excess of 500 mL within 3
    months prior to screening Visit 1.
    20 Current diagnosis of cancer.
    21 History of cancer, except if treated with apparent success with
    curative therapy (response duration of > 5 years).
    22 History of allogeneic bone marrow transplant.
    23 History of herpes zoster within 3 months prior to randomization at
    Visit 3 (Day 1).
    24 A helminth parasitic infection diagnosed within 6 months prior to
    randomization at Visit 3 (Day 1) that has not been treated, or has not
    responded to standard of care therapy.
    25 Receiving any prohibited concomitant medications or therapies as
    specified in the protocol (Section 4.7.3).
    26 History of a clinically significant non-skin infection within 4 weeks
    prior to Visit 3 (Day 1; including unexplained diarrhea) or clinical
    suspicion of a non-skin infection at the time of dosing of investigational
    product.
    27 History of a skin infection that requires systemic antibiotics, antiviral
    medication, or antifungal medication for > 7 days within 4 weeks prior to
    Visit 3 (Day 1) or clinical suspicion of a skin-infection at time of dosing
    of investigational product.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    • Percent change from baseline to Week 16 in EASI score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and at week 16
    E.5.2Secondary end point(s)
    Efficacy
    • EASI:
    Percentage of subjects achieving a 90% reduction from baseline in EASI score (EASI 90) at Week 16.
    Percentage of subjects achieving a 75% reduction from baseline in EASI score (EASI 75) at Week 16.
    Percentage of subjects achieving a 50% reduction from baseline in EASI score (EASI 50) at Week 16.
    Percent change from baseline to Week 8 in EASI score.
    • Percentage of subjects achieving an IGA of 0 (clear) or 1 (almost clear) with at least a 2 grade reduction from baseline score at Week 16.
    • Peak pruritus NRS: Percentage of subjects achieving a reduction of ≥ 3 from baseline to Week 16 in weekly mean of daily peak pruritus NRS.
    • Peak pruritus NRS: Change from baseline to Week 16 in weekly mean of daily peak pruritus NRS.
    • Skin pain NRS: Change from baseline to Week 16 in weekly mean of daily peak skin pain NRS.
    • SCORAD: Percent change from baseline to Week 16.
    • PGI-S at Week 16.
    • Change from baseline to Week 16 in:
    % BSA affected by AD.
    5-D itch.
    POEM.
    DLQI.

    Safety
    During the treatment and follow-up periods:
    • TEAEs and TESAEs.
    • Vital signs.
    • Safety laboratory analysis.
    • ECGs.
    Left ventricular ejection fraction as measured by echocardiogram.

    PK
    Serum MEDI3506 concentration profiles during the treatment and follow-up periods.

    Immunogenicity
    Incidence of ADA during the treatment and follow-up periods.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy
    baseline and at week 8 and 16

    PK and Immunogenicity
    baseline and at week 2,4,8,12,16,20,24

    Safety
    Throughout the study.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    United States
    Germany
    Poland
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 151
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-12-06. Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 108
    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 Decision2020-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-22
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