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    Summary
    EudraCT Number:2014-003725-17
    Sponsor's Protocol Code Number:D2213C00001
    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:2015-01-05
    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 number2014-003725-17
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects with Moderate-to-Severe Atopic Dermatitis
    EINE PHASE-2B, RANDOMISIERTE, DOPPELBLINDE, PLACEBOKONTROLLIERTE DOSISFINDUNGSSTUDIE, ZUR BEWERTUNG DER
    WIRKSAMKEIT UND SICHERHEIT VON TRALOKINUMAB BEI ERWACHSENEN PROBANDEN MIT MITTELSCHWERER BIS SCHWERER ATOPISCHER DERMATITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults with Atopic Dermatitis
    Phase II-Studie zur Bewertung der Wirksamkeit und Sicherheit von Tralokinumab bei erwachsenen Patienten mit
    Atopischem Ekzem (Atopischer Dermatitis)
    A.4.1Sponsor's protocol code numberD2213C00001
    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 SponsorMedImmune
    B.1.3.4CountryUnited Kingdom
    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 supportMedImmune
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune
    B.5.2Functional name of contact pointMedImmune Contact
    B.5.3 Address:
    B.5.3.1Street AddressMilstein Building, Granta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailClinicalTrialEnquiries@Medimmune.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 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
    Atopische Dermatitis
    E.1.1.1Medical condition in easily understood language
    Eczema
    atopisches Ekzem
    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 19.0
    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 in adults with atopic dermatitis using change from baseline in Eczema Area and Severity Index (EASI)
    Beurteilung der Wirksamkeit von Tralokinumab bei Erwachsenen mit Atopischer Dermatitis
    anhand der Veränderung der Ekzemfläche und des EASI zum Ausgangswert bei der Baseline-Visite.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of tralokinumab using efficacy measures of Scoring of Atopic Dermatitis (SCORAD) and Investigator's Global Assessment (IGA) in adults with atopic dermatitis
    - To evaluate the safety and tolerability of tralokinumab in adults with atopic dermatitis
    - To evaluate the effect of tralokinumab on quality of life in adults with atopic dermatitis
    - To characterize the pharmacokinetics (PK) and immunogenicity of tralokinumab in adults with atopic dermatitis
    - Bewertung der klinischen Wirksamkeit von Tralokinumab gemessen mit Hilfe der Wirksamkeitsmessgrößen für Atopische Dermatitis (AD) SCORAD und Investigator's Global Assessment (IGA) bei Erwachsenen mit AD
    - Bewertung der Sicherheit und Verträglichkemittelschwerer bis schwerer AD;
    - Bewertung des Effekts von Tralokinumab auf die Lebensqualität von Erwachsenen mit AD
    - Charakterisierung der Pharmakokinetik (PK) und Immunogenität von Tralokinumab bei Erwachsenen mit AD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-75 years
    - Physician diagnosis of atopic dermatitis for > 1 year
    - Atopic dermatitis involvement of ≥ 15% body surface area
    - EASI score of ≥ 12
    - SCORAD of ≥ 25
    - IGA score of ≥ 3
    - Effective birth control in line with protocol details
    - im Alter von 18-75 Jahren
    - klinische Diagnose der Atopischer Dermatitis > 1 Jahr
    - ASI Wert von ≥ 12
    - SCORAD von ≥ 25
    - IGA Wert von ≥ 3
    - effektive Schwangerschaftsverhütungsmethoden entsprechend den Festlegungen laut Protokoll
    E.4Principal exclusion criteria
    - History of anaphylaxis following any biologic therapy
    - Hepatitis B, C or HIV
    - Pregnant or breastfeeding
    - History of cancer
    - Previous receipt of tralokinumab
    - Bekannte anaphylaktische Reaktionen nach Behandlungen mit Biologika
    - Hepatitis B, C oder HIV-positiv
    - Schwangere oder stillende Frauen, Frauen in der Stillzeit
    - Krebserkrankungen in der medizinischen Vorgeschichte
    - Frühere Anwendung von Tralokinumab
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in EASI at Week 12
    Veränderung des EASI zwischen Baseline (Ausgangswert) und Woche 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Bi-weekly throughout study.
    2-wöchendlich während der Studie
    E.5.2Secondary end point(s)
    - Change from baseline in EASI
    - Safety and tolerability
    - Percentage of subjects achieving IGA of 0 (clear) or 1 (almost clear)
    - Change from baseline in SCORAD
    - Percentage of subjects achieving 50% reduction from baseline in EASI
    - Percentage of subjects achieving 50% reduction from baseline in SCORAD
    - Change from baseline in pruritus
    - Change from baseline in quality of life
    - Pharmacokinetics of tralokinumab
    - Immunogenicity of tralokinumab
    - Veränderung des EASI zum Ausgangswert;
    - Sicherheit und Verträglichkeit von Tralokinumab
    - Prozentsatz der Patienten, die einen IGA von 0 (geheitl) oder 1 (fast geheilt) erreichen;
    - Veränderung des SCORAD vom Ausgangswert;
    - Prozentsatz der Patienten, die eine 50%-ige Reduktion des Ausgangswertes des EASI-Scores erreichen (EASI 50);
    - Prozentsatz der Patienten, die eine 50%-ige Reduktion des Ausgangswertes des SCORAD erreichen (SCORAD 50);
    - Veränderung vom Ausgangswert des Juckreizes
    - Veränderung der Lebensqualität (DLQI) vom Ausgangswert;
    - Pharmakokinetisches Profil von Tralokinumab;
    - Immugenität von Tralokinumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be measured up to Week 12 for on-therapy effects and time points beyond end of treatment for off-therapy effects.
    Die sekundären Endpunkte werden bis zur Woche 12 auf on-Therapie-Effekte und an Zeitpunkten über das Ende der Behandlung hinaus für off-Therapie-Effekte gemessen.
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Germany
    Japan
    Poland
    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
    last visit of the last subject undergoing the trial
    letzte Visite des letzten Patienten
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 184
    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 Decision2015-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
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