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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-004201-13
    Sponsor's Protocol Code Number:LP0162-1326
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-10
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-004201-13
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab monotherapy in subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy
    Randomizowane, podwójnie zaślepione, kontrolowane placebo badanie
    kliniczne fazy III, mające na celu ocenę skuteczności i bezpieczeństwa
    stosowania tralokinumabu w monoterapii u pacjentów z atopowym zapaleniem
    skóry o nasileniu od umiarkowanego do ciężkiego, którzy są kandydatami do
    leczenia ogólnoustrojowego.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 trial to evaluate the efficacy and safety of tralokinumab in adults with moderate to severe atopic dermatitis (ECZTRA 2)
    Badanie fazy III mające na celu ocenę skuteczności i bezpieczeństwa tralokinumabu u dorosłych z umiarkowanym do ciężkim atopowym zapaleniem skóry (ECZTRA 2).
    A.4.1Sponsor's protocol code numberLP0162-1326
    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 pointStine Kihl-Plambek
    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.5.6E-mailkpbdk@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
    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 skory
    E.1.1.1Medical condition in easily understood language
    Eczema
    stan zapalny skory
    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 tralokinumab compared with placebo in treating moderate-to-severe Atopic dermatitis.

    Ocena skuteczności stosowania tralokinumabu w porównaniu z placebo w leczeniu atopowego zapalenia skóry o nasileniu od umiarkowanego do ciężkiego
    E.2.2Secondary objectives of the trial
    During the initial treatment period:
    - To evaluate the efficacy of tralokinumab on severity and extent of AD, itch,
    and health related quality of life compared with placebo.

    During the maintenance treatment period:
    - To evaluate maintenance of effect with continued tralokinumab dosing up to
    52 weeks compared to placebo for subjects achieving clinical response at 16 weeks.
    W fazie początkowej leczenia:
    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.

    W fazie podtrzymującej leczenie:
    Ocena utrzymywania się efektów przy ciągłym podawaniu tralokinumabu do tygodnia 52 w porównaniu z placebo u uczestników badania, u których zaobserwowano odpowiedź kliniczną w tygodniu 16.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 and above
    • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
    • Diagnosis of AD for ≥1 year.
    • Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
    • AD involvement of ≥10% body surface area at screening and baseline.
    • An EASI score of ≥12 at screening and 16 at baseline.
    • An IGA score of ≥3 at screening and at baseline.
    • A Worst Daily Pruritus numeric rating scale (NRS) average score of ≥4
    during the week prior to baseline.
    • Stable dose of emollient twice daily for at least 14 days before randomisation.
    - Wiek co najmniej 18 lat.
    - Rozpoznanie atopowego zapalenia skóry zgodnie z kryteriami Hanifina i Rajki (1980).
    - Rozpoznanie atopowego zapalenia skóry ≥1 rok.
    - Uczestnicy badania, u których, jak wynika z niedawnej dokumentacji medycznej, nie zaobserwowano odpowiedniej odpowiedzi na leczenie lekami podawanymi miejscowo lub u których stosowanie leków podawanych miejscowo jest niewskazane.
    - Zajęcie ≥10% powierzchni ciała przez atopowe zapalenie skóry podczas wizyty przesiewowej i wyjściowej.
    - Wskaźnik EASI ≥12 podczas wizyty przesiewowej i 16 podczas wizyty wyjściowej.
    - Wskaźnik IGA ≥3 podczas wizyty przesiewowej i wyjściowej.
    - Średni wynik dla najgorszego dziennego świądu w oparciu o skalę numeryczną (NRS) wynoszący ≥4 w ciągu tygodnia przed wizytą wyjściową.
    - Stała dawka środka nawilżającego skórę dwa razy na dobę 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 and/or TCI within 2 weeks prior to randomisation.
    • 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 zaplenia 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 miejscowe kortykosteroidem i/lub inhibitorem kalcyneuryny w ciągu 2 tygodni przed randomizacją.
    - Aktywne zakażenie skóry w ciągu 1 tygodnia przed randomizacją.
    - Klinicznie istotna infekcja w ciągu 4 tygodni przed randomizacją.
    - Zakażenie robakami pasożytniczymi 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)
    For the initial treatment period:
    - IGA score of 0 (clear) or 1 (almost clear) at Week 16
    - EASI75 at Week 16
    W fazie początkowej leczenia:
    - Wynik na skali IGA 0 (skóra czysta) lub 1 (skóra prawie czysta) w tygodniu 16
    - Wskaźnik EASI75 w tygodniu 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Bi-weekly throughout study.
    co dwa tygodnie w trakcie badania
    E.5.2Secondary end point(s)
    For the initial treatment period:
    Severity and extent of AD: Change in SCORAD from baseline to Week 16
    Itch: Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4
    from baseline to Week 16.
    Quality of life: Change in DLQI score from baseline to Week 16

    For the maintenance treatment period:
    IGA of 0/1 at Week 52 among subjects with IGA of 0/1 at Week 16 achieved
    without rescue medication after initial randomisation to tralokinumab
    EASI75 at Week 52 among subjects with EASI75 at Week 16 achieved
    without rescue medication after initial randomisation to tralokinumab
    W fazie początkowej leczenia:

    Nasilenie oraz zakres atopowego zapalenia skóry: Zmiana w skali SCORAD od momentu oceny wyjściowej do tygodnia 16.
    Świąd: Zmniejszenie najgorszego dziennego świądu na skali numerycznej - Worst Daily Pruritus NRS (średnia tygodniowa) o co najmniej 4 od momentu oceny wyjściowej do tygodnia 16.
    Jakość życia: Zmiana wskaźnika DLQI od momentu oceny wyjściowej do tygodnia 16.

    W fazie leczenia podtrzymującego
    - Wartość IGA wynosząca 0/1 w tygodniu 52 wśród uczestników z wartością IGA wynoszącą 0/1 w tygodniu 16 osiągnięta bez leczenia ratunkowego po wstępnej randomizacji do grupy leczonej tralokinumabem.
    - Wskaźnik EASI75 w tygodniu 52 wśród uczestników ze wskaźnikiem EASI75 w tygodniu 16 osiągnięta bez leczenia ratunkowego po wstępnej randomizacji do grupy leczonej tralokinumabem.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Bi-weekly throughout study for assessment conducted by the HCP. For Puritus 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. 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 Yes
    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 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 trial5
    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 EEA40
    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
    Korea, Republic of
    Russian Federation
    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
    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 years2
    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 years3
    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: 740
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 780
    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)
    Subjects on active treatment who complete the Week 52 visit and are in response (IGA 0/1 or EASI75), will be invited to enter a long-term extension trial if they are considered eligible for the trial. The long term extension trial will be conducted under a separate protocol (LP0162 1337).
    Osoby będące w aktywnym leczeniu, które ukończyły wizytę w Tygodniu 52 i osiągnęły odpowiedź na leczenie (IGA 0/1 lub EASI75), zostaną zaproszone do udziału w długoterminowym przedłużeniu badania z zastosowaniem tralokinumabu, jeśli będą spełniać kryteria kwalifikalności do tego badania. Długoterminowe przedłużenie badania będzie prowadzone pod odrębnym protokole (LP0162 1337).
    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 Decision2017-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-14
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