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    Summary
    EudraCT Number:2018-000746-19
    Sponsor's Protocol Code Number:LP0162-1337
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-08-23
    Trial 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 number2018-000746-19
    A.3Full title of the trial
    An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTEND
    A.3.2Name or abbreviated title of the trial where available
    ECZTEND
    A.4.1Sponsor's protocol code numberLP0162-1337
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03587805
    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 SponsorLEO Pharma A/S
    B.1.3.4CountryDenmark
    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 supportLeo Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeo Pharma A/S
    B.5.2Functional name of contact pointGlobal Clinical Operations / MedSci
    B.5.3 Address:
    B.5.3.1Street AddressIndustriparken 55
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    B.5.3.4CountryDenmark
    B.5.4Telephone number+455365 7553
    B.5.6E-mailseqdk@leo-pharma.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 nameTralokinumab
    D.3.2Product code CAT-354
    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 INNTralokinumab
    D.3.9.1CAS number 1044515-88-9
    D.3.9.3Other descriptive nameCAT-354
    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 Yes
    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
    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 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
    To evaluate the long-term safety of tralokinumab
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of tralokinumab given as continuous treatment, re-treatment, or introduced for the first time in tralokinumab naïve subjects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed and dated informed consent has been obtained prior to any protocol-related procedures. Signed and dated informed consent for adolescent subjects must be provided by the subject’s legal representative(s) and by the subject in the form of a signed and dated informed assent (as applicable according to national laws or regulations).
    2. Subjects must have completed* the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, or-1343, -1346, or TRA-WEI-0015-I.
    3. Subjects must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
    4. Subjects must be able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
    5. Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days prior to baseline.
    6. Female subjects of childbearing potential (defined as Tanner stage ≥3 or menarche)* must use a highly effective** form of birth control (confirmed by the investigator) continuously for at least 1 month prior to the pregnancy test at baseline (Week 0), throughout the trial, and for at least 16 weeks (5 half lives of the IMP) after the last administration of IMP.
    * A female subject is defined as not being of childbearing potential if she is:
    •Postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
    •Premenarchal-
    **A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), same sex partner, or vasectomised partner (given that the subject is monogamous).
    E.4Principal exclusion criteria
    1.Any condition that required permanent discontinuation of trial treatment in the parent trial
    2.More than 26 weeks have elapsed since the subject received the last IMP injection in the parent trial
    3.Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator
    4.Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject
    5.Receipt of any marketed biological therapy or investigational biologic agent (other than tralokinumab), including immunoglobulin, anti-IgE, or dupilumab:
    •Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer
    •Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline
    6.Treatment with the following medications within 5 half-lives prior to baseline:
    •Systemic immunosuppressive/immunomodulating drugs (for example, methotrexate, cyclosporine, azathioprine, mycophenolate-mofetil, Janus kinase inhibitors)
    •Systemic corticosteroids (excluding topical, ophthalmic, inhaled, or intranasal delivery)
    7.Treatment with topical PDE-4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline
    8.Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb are eligible provided they are vaccinated against hepatitis B and have negative HBsAg and HBcAb
    9.Known or suspected hypersensitivity to any component(s) of the IMP
    10.History of anaphylaxis following any biological therapy
    11.History of immune complex disease
    12.History of cancer:
    •Subjects who have had basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date when informed consent was obtained
    •Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date when informed consent was obtained
    13.Tuberculosis requiring treatment within 12 months prior to screening
    14.History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history or subject’s verbal report
    15.Current participation in any other interventional clinical trial, except for tralokinumab trials LP0162-1325, 1326, 1334, 1339, 1341, 1342, 1346, 1343, or TRA-WEI-0015-I
    17.Receipt of live attenuated vaccines 30 days prior to baseline and during the trial including the safety follow-up period
    18.Receipt of blood products within 4 weeks of baseline
    19.Major surgery within 8 weeks prior to baseline, or planned in-patient surgery or hospitalisation during the trial
    20.History of subject or subject’s legal representative(s) of chronic alcohol or drug abuse within 12 months prior to screening, or any condition (e.g., psychotic state, language barrier or other) associated with poor compliance, as judged by the investigator
    21.Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals
    22.Subjects who are legally institutionalised
    23.Female subjects who are pregnant, breastfeeding, or lactating
    24.History of attempted suicide or significant risk of suicide
    25.History of a clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator or sponsor’s medical expert, may compromise the safety of the subject in the trial. Clinically significant infections are defined as:
    •A systemic infection
    •A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication
    26.A helminth parasitic infection within 6 months prior to the date when informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
    27.Any disorder that is not stable and in the opinion of the investigator could:
    •Affect the safety of the subject throughout the trial
    •Influence the findings of the trial
    •Impede the subject’s ability to complete the trial
    28.Any abnormal finding which in the opinion of the investigator may:
    •Put the subject at risk because of their participation in the trial
    •Influence the results of the trial
    •Influence the subject’s ability to complete the trial
    E.5 End points
    E.5.1Primary end point(s)
    Number of adverse events during the treatment period from baseline up to Week 268
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 268
    E.5.2Secondary end point(s)
    1) Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
    2) At least 75% reduction in Eczema Area and Severity Index (EASI75)² relative to baseline in parent trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA135
    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
    Canada
    Japan
    United States
    Belgium
    Czechia
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 90
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1510
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 880
    F.4.2.2In the whole clinical trial 1600
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NIHR CRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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