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    Summary
    EudraCT Number:2018-001997-52
    Sponsor's Protocol Code Number:20170755
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-01-02
    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 number2018-001997-52
    A.3Full title of the trial
    A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined with Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Dose-Ranging, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis.
    A.4.1Sponsor's protocol code number20170755
    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 SponsorAmgen Inc
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressRiesstr. 24
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80992
    B.5.3.4CountryGermany
    B.5.4Telephone number+498002643644
    B.5.6E-maileudemedinf@amgen.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 nametezepelumab
    D.3.2Product code 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 INNTEZEPELUMAB
    D.3.9.2Current sponsor codeAMG 157
    D.3.9.4EV Substance CodeSUB179650
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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 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 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
    Part A:
    • To evaluate the effect of tezepelumab compared with placebo, assessed using the Investigator’s Global Assessment (IGA) and Eczema Area and Severity Index (EASI).
    Part B:
    • Part B is an estimation study; no hypotheses will be formally tested.
    E.2.2Secondary objectives of the trial
    Part A:
    • To estimate the effect of tezepelumab compared with placebo on the efficacy measure of EASI.
    • To estimate the time needed to reach EASI 50/75/90.
    • To estimate the effect of tezepelumab compared with placebo on the efficacy measure of Scoring Atopic Dermatitis (SCORAD).
    • To estimate the effect of tezepelumab compared with placebo on the
    patient-reported outcome (PRO) measure of pruritus assessed using an numeric rating scale (NRS).
    • To characterize the pharmacokinetics (PK) of tezepelumab.

    Part B:
    • Part B is an estimation study; no hypotheses will be formally tested.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional substudies include skin punch biopsies (biomarker) and the
    sample for DNA analysis (pharmacogenetics).
    E.3Principal inclusion criteria
    - Subject has provided informed consent prior to initiation of any study
    specific activities/procedures
    - Age 18 to 75 years at screening
    - Clinical diagnosis of chronic AD (also known as atopic eczema) for at
    least 2 years prior to screening and has confirmed AD
    - AD that affects 10% body surface area as assessed by EASI at
    screening and on day 1
    - An IGA score of 3 at screening and on day 1
    - An EASI score of 16 at screening and on day 1
    - Subject discontinued treatment with TCS, topical calcineurin inhibitors
    (TCI), and prescription moisturizers containing TCS or TCI for at least
    the 7 days immediately prior to the first dose of investigational product
    - Documented recent history (within 12 months before the screening
    visit) of inadequate response to treatment with topical TCS or subjects
    for whom topical treatments are otherwise medically inadvisable (ie,
    because of important side effects or safety risks)
    - Inadequate response is defined as failure to achieve and
    maintain remission or a low disease activity state (comparable to IGA 0
    = clear to IGA 2 = mild) despite treatment with a daily regimen of TCS of
    medium or higher potency (with or without TCI as appropriate).
    E.4Principal exclusion criteria
    - Active dermatologic conditions, which might confound the diagnosis of
    AD or would interfere with the assessment of treatment, such as scabies,
    seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis,
    allergic contact dermatitis, or irritant contact dermatitis
    - History of a clinically significant infection within 28 days prior to day 1
    that, in the opinion of the investigator or medical monitor, might
    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
    either of the following:
    - 1) a systemic infection; or
    - 2) a serious skin infection requiring parenteral antibiotic, antiviral, or
    antifungal medication
    - Diagnosis of a helminth parasitic infection within 6 months prior to
    screening that had not been treated with or had failed to respond to
    standard of care therapy
    - Documented medical history of chronic alcohol or drug abuse within 12
    months prior to screening
    - History of anaphylaxis following any biologic therapy
    - Evidence of active liver disease at screening, including jaundice or
    aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
    alkaline phosphatase greater than twice the upper limit of normal (ULN)
    - Subjects who, in the opinion of the investigator, have evidence of
    active tuberculosis (TB), either treated or untreated, or a positive
    QuantiFERON-tuberculosis Gold (QFT-G) test for TB during screening.
    Subjects with an indeterminate QFT-G may be enrolled if they have ALL
    of
    the following:
     - No symptoms of TB: productive, prolonged cough (> 3 weeks);
    coughing up blood; fever; night sweats; unexplained appetite loss;
    unintentional weight loss
     - No evidence of active TB on chest radiograph within 3 months prior
    to the first dose of investigational product. Note: Chest radiograph is not
    part of screening procedure and will be the responsibility of the
    Investigator as this is outside the scope of this protocol
    - Positive hepatitis B surface antigen or hepatitis C antibody serology.
    Subjects with a history of hepatitis B vaccination without a history of
    hepatitis B are allowed to enroll in the study.
    - Positive human immunodeficiency virus (HIV) test at screening or the
    subject is taking antiretroviral medications, as determined by medical
    history, prior medications, and/or the subject's verbal report
    - History of malignancy, except for basal cell carcinoma or in situ
    carcinoma of the cervix treated with apparent success with curative
    XML File Identifier: iq8vsrjQC/+HaVi9yU5UBpjZstM=
    Page 11/21
    therapy >= 12 months prior to screening or other malignancies treated
    with apparent success with curative therapy >= 5 years prior to
    screening
    - History or evidence of severe depression, schizophrenia, previous
    suicide attempts, or suicidal ideation
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    • IGA score of 0 (clear) or 1 (almost clear) (IGA 0/1) at week 16
    • 75% reduction in EASI (EASI 75) at week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    • week 16
    • week 16
    E.5.2Secondary end point(s)
    Part A:
    • 50% and 90% reduction in EASI (EASI 50/90) at week 16
    • Time at which EASI 50/75/90 is achieved from day 1
    • SCORAD at week 16
    • Pruritus NRS at week 16
    • Serum trough concentrations of tezepelumab at scheduled visits
    E.5.2.1Timepoint(s) of evaluation of this end point
    • week 16
    • monthly
    • week 16
    • week 16
    • week 2, 4, and 24
    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 No
    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 Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Czech Republic
    Estonia
    Germany
    Hungary
    Japan
    Korea, Republic of
    Latvia
    Poland
    Spain
    Switzerland
    Ukraine
    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
    Primary Completion Date = Week 16 Part A
    End of Study = LVLS
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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.1.2.1Number of subjects for this age range: 280
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 300
    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 Decision2019-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-12-22
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