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    Summary
    EudraCT Number:2014-003384-38
    Sponsor's Protocol Code Number:R668-AD-1415
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-29
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003384-38
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
    INVESTIGATING THE EFFICACY AND SAFETY OF MULTIPLE DUPILUMAB
    DOSE REGIMENS ADMINISTERED AS MONOTHERAPY FOR MAINTAINING
    TREATMENT RESPONSE IN PATIENTS WITH ATOPIC DERMATITIS
    Studio di fase 3, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia e la sicurezza di regimi di dosaggio multipli di dupilumab somministrato in monoterapia per mantenere la risposta al trattamento in pazienti con dermatite atopica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to confirm the efficacy and safety of different dupilumab dose regimens in adults with atopic dermatitis (AD)
    Studio per valutare l’efficacia e la sicurezza di regimi differenti di dosaggio di dupilumab somministrato in adulti con dermatite atopica (DA)
    A.3.2Name or abbreviated title of the trial where available
    Liberty AD Solo - Continue
    Liberty AD Solo - Continue
    A.4.1Sponsor's protocol code numberR668-AD-1415
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12345678
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT12345678
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-1234-1234
    A.5.4Other Identifiers
    Name:IND 107969Number:IND 107969
    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 SponsorREGENERON PHARMACEUTICALS, 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 support Regeneron Pharmaceuticals Inc. - Stati Uniti d'America
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrial@regeneron.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 nameDupilumab
    D.3.2Product code REGN668/SAR231893
    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 INNDupilumab
    D.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeREGN668/SAR231893
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB179171
    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) Yes
    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 in pre-filled syringe
    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
    Dermatite atopica
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis / Eczema
    Dermatite atopica / 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 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
    The primary objective of the study is to assess the ability of different dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with dupilumab monotherapy compared to placebo
    L’obiettivo primario dello studio è di valutare la capacità di diversi regimi di dosaggio di dupilumab, somministrato in monoterapia, di mantenere la risposta al trattamento ottenuta dopo 16 settimane di trattamento iniziale con dupilumab in monoterapia rispetto al placebo
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the safety of different dupilumab dose regimens administered as monotherapy over a period of
    36 weeks
    L’obiettivo secondario dello studio è di valutare la sicurezza di diversi regimi di dosaggio di dupilumab somministrato in monoterapia nell’arco di 36 settimane
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient must meet the following criteria to be eligible for inclusion in the study:
    1. Must have completed the treatment phase in 1 of the two 16-week initial treatment studies (R668-AD-1334 or R668-AD-1416).
    2. Must have achieved at least 1 of the following 2 treatment success criteria:
    IGA = 0 or 1 (clear or almost clear) at week 16 OR EASI-75 (at least 75% reduction in EASI score from baseline to week 16)
    3. Must be willing and able to comply with clinic visits and study-related procedures
    4. Must provide signed informed consent
    5. Must be able to understand and complete study-related questionnaires
    Il paziente deve soddisfare tutte le seguenti condizioni al fine di essere eligibile nello studio:
    1. deve avere completato la fase di trattamento di 16 settimane di uno dei due studi di trattamento iniziali (R668-AD-1334 or R668-AD-1416)
    2. deve avere raggiunto almeno uno dei due criteri di successo del trattamento seguenti:
    Valutazione globale dello sperimentatore (Investigator’s Global Assessment, IGA) pari a 0 o 1 (scomparsa o quasi scomparsa) alla settimana 16 OPPURE un Eczema Area and Severity Index (EASI)-75 alla settimana 16 (riduzione di almeno il 75% nel punteggio EASI dal basale alla settimana 16).
    3. deve manifestare la volontà e la possibilità di rispettare le visite e le procedure di studio
    4. deve fornire consenso informato scritto
    5. deve comprendere e completare i questionari relativi allo studio
    E.4Principal exclusion criteria
    A patient who meets any of the following criteria will be excluded from the study:
    1. Receipt of rescue medication for AD in the initial treatment study
    2. Any conditions that require permanent discontinuation of study treatment in either initial
    treatment study
    3. Planned or anticipated major surgical procedure during the patient's participation in this study
    4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
    during this study
    Birth control exclusion criterion # 5is listed in protocol section 4.2.2
    Il paziente che soddisfi una delle seguenti condizioni sarà escluso dallo studio:
    1. assunzione -nello studio iniziale di trattamento- di rescue medication (farmaco di soccorso) per trattamento di dermatite atopica
    2. qualsiasi condizione che richieda l’interruzione definitiva del trattamento in entrambi gli studi iniziali di trattamento
    3. rilevante procedura chirurgica (pianificata o anticipata) durante la partecipazione del paziente al presente studio
    4. donne in gravidanza o in allattamento o donne che pianifichino una gravidanza o un allattamento durante lo studio
    Sistemi di controllo delle nascite (criterio di esclusione #5) come specificato nel protocollo, paragrafo 4.2.2
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with IGA scores of 0 or 1 (clear or almost clear) at week 36. For the EMA and EMA Reference Market countries only, the co-primary efficacy endpoint is: EASI-75: Proportion of patients with EASI-75 (≥75% improvement) at week 36 compared to the baseline EASI in the initial treatment study (R668-AD-1334 or R668-AD-1416)
    Proporzione di pazienti con punteggi IGA pari a 0 o 1 (scomparsa o quasi scomparsa) alla settimana 36. Per EMA e per i Paesi che fanno riferimento a EMA l'endpoint co-primario è: EASI-75: Proporzione di pazienti con EASI-75 (≥75% di miglioramento) alla settimana 36 rispetto all’EASI basale negli studi di trattamento iniziali (R668-AD-1334 o R668-AD-1416)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be determined at week 36
    Settimana 36
    E.5.2Secondary end point(s)
    EASI-75: Proportion of patients with EASI-75 (≥75% improvement) at week 36 compared to the baseline EASI in the initial treatment study (R668-AD-1334 or R668-AD-1416). Change in SCORAD from baseline to week 36. Percent of patients whose Pruritus NRS increased by 3 or more points from baseline to week 36
    EASI-75: Proporzione di pazienti con EASI-75 (≥75% di miglioramento) alla settimana 36 rispetto all’EASI basale nello studio di trattamento iniziale (R668 AD-1334 o R668-AD-1416) Variazione dell’indice SCORAD dal basale alla settimana 36 Percentuale di pazienti la cui intensità massima del prurito secondo la Scala di valutazione numerica (Numerical Rating Scale, NRS) è aumentata di 3 o più punti dal basale alla settimana 36
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be determined from baseline to week 36
    Dalla visita al Basale alla settimana 36
    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 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 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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA128
    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
    European Union
    Hong Kong
    Japan
    Korea, Republic of
    Singapore
    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 patient last visit in follow up phase (week 48)
    LVLS nella fase di follow-up (settimana 48)
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 400
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 346
    F.4.2.2In the whole clinical trial 440
    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)
    Patients who complete the treatment period may be eligible to enroll in an open-label extension (OLE) study starting at week 36. Patients who
    do not transition into the OLE study before week 48 will undergo an additional follow-up visit at week 40 and a final (end-of-study) visit at week 48.
    I pazienti che completeranno il trattamento potranno essere eligibili per partecipare a uno studio di estensione in aperto che partirà alla settimana 36. I pazienti che non prenderanno parte a questo studio in aperto prima della settimana 48, saranno sottoposti a una visita di follow-up aggiuntiva alla settimana 40 e ad una visita finale (fine dello studio) alla settimana 48.
    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 Decision2015-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-18
    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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