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    The EU Clinical Trials Register currently displays   38147   clinical trials with a EudraCT protocol, of which   6265   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2017-005143-33
    Sponsor's Protocol Code Number:LP0162-1334
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-07-04
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-005143-33
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, parallel-group, multi-centre trial to evaluate the efficacy, safety, and tolerability of tralokinumab monotherapy in adolescent subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy - ECZTRA 6 (ECZema TRAlokinumab trial no.6)
    Randomizowane, podwójnie zaślepione, kontrolowane placebo, z równoległymi grupami, wieloośrodkowe badanie, mające na celu ocenę skuteczności, bezpieczeństwa i tolerancji stosowania monoterapi tralokinumabem u nastolatków z atopowym zapaleniem skóry o nasileniu od umiarkowanego do ciężkiego, którzy są kandydatami do leczenia systemowego.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tralokinumab monotherapy for adolescent subjects with moderate-to-severe atopic dermatitis - ECZTRA 6
    Monoterapia Tralokinumabem u nastolatków z umiarkowanym do ciężkiego atopowym zapaleniem skóry - ECZTRA 6
    A.4.1Sponsor's protocol code numberLP0162-1334
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/321/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLEO Pharma A/S
    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.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 pointStine Kihl-Plambek
    B.5.3 Address:
    B.5.3.1Street AddressIndustriparken 55
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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
    Atopowe zapalenie skóry
    E.1.1.1Medical condition in easily understood language
    stan zapalny skóry
    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 20.0
    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 efficacy of subcutaneous administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe atopic dermatitis.
    Ocena skuteczności podskórnego (SC) podawania tralokinumabu w porównaniu z placebo w leczeniu nastolatków (wiek od 12 do <18 lat) z umiarkowanym lub ciężkim AZS.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of tralokinumab on severity and extent of atopic dermatitis, itch, and health-related quality of life compared with placebo.

    To investigate the safety, immunogenicity, and tolerability of subcutaneous administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe atopic dermatitis.
    Ocena skuteczności stosowania tralokinumabu w odniesieniu do nasilenia i rozległości atopowego zapalenia skóry, swędzenia i jakości życia zależnej od stanu zdrowia w porównaniu z placebo

    Zbadanie bezpieczeństwa stosowania, immunogenności i tolerancji podawania tralokinumabu drogą podskórną w porównaniu z placebo w leczeniu nastolatków (wiek od 12 do <18 lat) z AZS o przebiegu umiarkowanym do ciężkiego
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 12 to 17.
    • Diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD.
    • History of AD for ≥1 year.
    • History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
    • AD involvement of ≥10% body surface area at screening and baseline.
    • Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
    • Wiek od 12 do17 lat.
    • Rozpoznanie AZS zgodnie z kryteriami Hanifina i Rajki (1980 r.).
    • W wywiadzie AZS trwające ≥1 roku.
    • W wywiadzie niepowodzenie leczenia kortykosteroidem stosowanym miejscowo (TCS; Europa: klasa 3 lub wyższa, USA: klasa 4 lub niższa) i/lub miejscowym inhibitorem kalcyneuryny (TCI) bądź uczestnicy, u których leczenie AZS stosowane miejscowo jest medycznie niezalecane.
    • Zajęcie ≥10% powierzchni ciała przez AZS podczas wizyty przesiewowej i wyjściowej.
    • Stała dawka środka nawilżającego skórę (emolientu) dwa razy na dobę (lub częściej w razie potrzeby) przez co najmniej 14 dni przed randomizacją.
    E.4Principal exclusion criteria
    • Active dermatologic conditions that may confound the diagnosis of AD.
    • Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
    • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
    • Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
    • Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin E) including dupilumab or investigational biologic agents.
    • Active skin infection within 1 week prior to randomisation.
    • Clinically significant infection within 4 weeks prior to randomisation.
    • A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
    • Tuberculosis requiring treatment within the 12 months prior to screening.
    • Known primary immunodeficiency disorder.
    • Aktywne schorzenia dermatologiczne, które mogą przeszkodzić w rozpoznaniu atopowego zapalenia skóry.
    • Korzystanie z solarium lub fototerapii w ciągu 6 tygodni przed randomizacją.
    • Leczenie ogólnoustrojowymi lekami immunosupresyjnymi/immunomodulacyjnymi i/lub ogólnoustrojowym kortykosteroidem w ciągu 4 tygodni przed randomizacją.
    • Leczenie za pomocą TCS, TCI lub inhibitora fosfodiesterazy typu 4 (PDE4) podawanego miejscowo w ciągu 2 tygodni przed randomizacją.

    • Otrzymywanie jakiegokolwiek wprowadzonego na rynek leczenia biologicznego (np. immunoglobulinami czy przeciwciałami anty-IgE), w tym dupilumabu i eksperymentalnych środków biologicznych.
    • Aktywne zakażenie skóry w ciągu 1 tygodnia przed randomizacją.
    • Klinicznie istotne zakażenie w ciągu 4 tygodni przed randomizacją.
    • Zakażenie pasożytami w ciągu 6 miesięcy przed datą uzyskania świadomej zgody.
    • Gruźlica wymagająca leczenia w ciągu 12 miesięcy przed wizytą przesiewową.
    • Znane pierwotne niedobory odporności.
    E.5 End points
    E.5.1Primary end point(s)
    • Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16
    • At least 75% reduction in Eczema Area and Severity Index (EASI75) at Week 16
    • Wynik w skali ogólnej oceny przez badacza (ang. Investigator’s Global Assessment, IGA) równy 0 (skóra czysta) lub 1 (skóra prawie czysta) w tygodniu 161.
    • Co najmniej 75-procentowe zmniejszenie obszaru zajęcia skóry na skutek atopowego zapalenia skóry i wskaźnik nasilenia (EASI75) w 16. tygodniu2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Bi-weekly from baseline until Week 52
    Co dwa tygodnie od wizyty wyjściowej (baseline) aż do tygodnia 52

    E.5.2Secondary end point(s)
    Severity and extent of AD:
    • Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16
    • Reduction of Adolescent Pruritus numeric rating scale (NRS) (weekly average) of at least 4 from baseline to Week 16
    Health-related quality of life:
    • Change in Children’s Dermatology Life Quality Index (CDLQI) score from baseline to Week 16

    • Number of adverse events.
    • Presence of anti-drug antibodies (yes/no).
    Nasilenie i rozległość AZS:

    • Zmiana wyniku w skali nasilenia AZS (SCORAD) od wizyty wyjściowej do tygodnia 16.


    • Zmniejszenie świądu u młodzieży na skali numerycznej (NRS) (średnia tygodniowa) o co najmniej 4 od wizyty wyjściowej do tygodnia 16.

    Jakość życia zależna od stanu zdrowia:

    • Zmiana dermatologicznego wskaźnika jakości życia u dzieci (CDLQI) od wizyty wyjściowej do 16 tygodnia.

    • Liczba zdarzeń niepożądanych
    • Obecność przeciwciał przeciw lekowych (obecność/brak).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Bi-weekly from baseline to Week 52 for assessments conducted by the HCP.
    For Pruritus the assessment is done on a daily basis using an eDiary.
    For DLQI completed by the subject every 2, 4 or 8 weeks.
    Ocena będzie dokonywana, co drugi tydzień przez badacza prowadzącego w trakcie trwania badania od wizyty wyjściowej do tygodnia 52.
    Ocena świądu będzie dokonywana codziennie przy użyciu elektronicznego dzienniczka eDiary.
    Wskaźnik wpływu dolegliwości skórnych na jakość życia (DLQI) będzie uzupełniany przez pacjenta co każdy 2,4 oraz 8 tydzień.
    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 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. 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 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 trial3
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Zakończenie badania definiowane jest, jako ostatnia wizyta ostatniego pacjenta w badaniu
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days7
    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: 294
    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) Yes
    F. of subjects for this age range: 294
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 294
    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)
    The subjects will be treated at the investigator's discretion or referred to other physician(s) according to standard practice
    Pacjenci będą traktowani według uznania badacza lub odesłani do innego lekarza (ów) zgodnie ze standardową praktyką lekarską.
    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 Decision2018-10-08
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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