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    Summary
    EudraCT Number:2018-004705-26
    Sponsor's Protocol Code Number:LPS15497
    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:2021-06-18
    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 number2018-004705-26
    A.3Full title of the trial
    A randomized double blind placebo controlled study evaluating the effect of dupilumab on sleep in adult patients with moderate to severe atopic dermatitis
    Studio randomizzato, in doppio cieco controllato verso placebo volto a valutare l'efficacia di dupilumab sul sonno in pazienti adulti con dermatite atopica da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SAR231893-LPS15497- "Dupilumab effect on Sleep in AD patients"
    SAR231893-LPS15497 - “Efficacia di dupilumab sul sonno in pazienti affetti da Dermatite Atopica”
    A.3.2Name or abbreviated title of the trial where available
    DUPISTAD
    DUPISTAD
    A.4.1Sponsor's protocol code numberLPS15497
    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 SponsorSANOFI-AVENTIS GROUPE
    B.1.3.4CountryFrance
    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 supportSanofi Aventis Groupe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.p.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 [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.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    dermatite atopica
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis
    dermatite atopica
    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 PT
    E.1.2Classification code 10012438
    E.1.2Term Dermatitis atopic
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 effect of dupilumab on sleep quality in adult patients with moderate to severe atopic dermatitis (AD)
    Valutare l’efficacia di dupilumab sulla qualità del sonno nei pazienti adulti con dermatite atopica (DA) da moderata a grave.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation. To continue to assess the safety and tolerability throughout the study
    Valutare l’efficacia di dupilumab su parametri quantitativi del sonno oggettivi e soggettivi, sugli esiti correlati alla DA e sulle conseguenze diurne della privazione di sonno. Continuare a valutare la sicurezza e la tollerabilità durante tutto lo studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants, male or female 18 years or older,
    - with diagnosed chronic atopic dermatitis (AD), demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance
    - having applied skin emolients (moisturizers) at least 7 days before randomization
    - having applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before randomization
    - willing and able to comply with all clinic visits and study-related procedures
    - providing signed informed consent
    Partecipanti maschi e femmine di età pari a 18 anni o superiore
    - Con Diagnosi di Dermatite Atopica (DA) cronica dimostrata, con 1) Risposta inadeguata ai farmaci topici o 2) prevista gravità di AD e 3) disturbi del sonno
    - aver applicato emollienti per la pelle (idratanti) almeno 7 giorni prima della randomizzazione
    - che hanno applicato corticosteroidi topici a media potenza (TCS) su tutte le lesioni da AD attive almeno 7 giorni prima della randomizzazione
    - disponibilità e capacità di rispettare tutte le visite cliniche e le procedure correlate allo studio
    - in grado di fornire il consenso informato firmato
    E.4Principal exclusion criteria
    Participants excluded from the study:
    - with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that may present unreasonable risk to patients or interfere with study assessment, or any severe concomitant illness(es) that would adversely affect the patient's participation in the study, and contraindications of topical corticosteroids
    - at baseline, presence of any conditions listed as criteria for study drug discontinuation
    The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
    Partecipanti esclusi dallo studio:
    - con nota ipersensibilità a Dupixent, depressione clinica, anamnesi di abuso di droghe, problemi di sonno non correlati all'AD, pattern di sonno irregolare, infezioni attive / acute, gravi condizioni mediche, anomalie di laboratorio, qualsiasi condizione che possa presentare un rischio irragionevole per i pazienti o interferire con le valutazioni dello studio o qualsiasi malattia concomitante grave che potrebbe interferire negativamente sulla partecipazione del paziente allo studio e controindicazioni dei corticosteroidi topici
    - al basale, presenza di eventuali condizioni elencate come criteri per l'interruzione del farmaco in studio
    Le informazioni di cui sopra non intendono contenere tutte le considerazioni relative alla potenziale partecipazione di un paziente a una sperimentazione clinica
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline to Week 12 in sleep quality numerical rating scale (NRS) : Percentage change from baseline to Week 12 in sleep quality. Sleep quality is measured daily using a numerical rating scale; weekly average is used for the analysis
    Variazione percentuale rispetto al basale alla Settimana 12 nel punteggio della scala di valutazione numerica (NRS) per la qualità del sonno. Variazione percentuale rispetto al basale alla Settimana 12 per la qualità del sonno. La qualità del sonno è misurata giornalmente usando una scala di valutazione numerica; settimanalmente la media è usata per le analisi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    DAL BASALE ALLA SETTIMANA 12
    E.5.2Secondary end point(s)
    1 : Change from baseline to Week 12 in sleep efficiency based on actigraphy data : Absolute change from baseline to Week 12 in sleep efficiency based on actigraph data. Sleep Efficiency is calculated as the proportion of time spent asleep vs total time in bed, expressed as a percentage. This is assessed daily and weekly average is used in the analysis
    2 : Change from baseline to Week 12 in total sleep time based on actigraphy data : Absolute change from baseline to Week 12 in total sleep time based on actigraph data. Total sleep time is assessed daily; Weekly average is used in the analysis
    3 : Change from baseline to Week 12 in wake after sleep onset based on actigraph data : Absolute change from baseline to Week 12 in wake after sleep onset (WASO) based on actigraph data. WASO is assessed daily; Weekly average is used in the analysis
    4 : Change from baseline to Week 12 in sleep latency based on actigraph data : Absolute change from baseline to Week 12 in sleep latency based on actigraph data. Sleep latency is assessed daily; weekly average is used in the analysis
    5 : Percent change from baseline to Week 12 in pruritus : Percentage change from baseline to Week 12 in pruritus. Pruritus is measured daily using a numerical rating scale; weekly average is used for the analysis
    6 : Change from baseline to Week 12 in SCORing Atopic Dermatitis (SCORAD) total score : Absolute change from baseline to Week 12 in SCORAD total score
    7 : Change from baseline to Week 12 in SCORAD sleep Visual Analog Scale (VAS) subscore : Absolute change from baseline to Week 12 in SCORAD sleep VAS subscore
    8 : Change from baseline to Week 12 in Patient Oriented Eczema Measure (POEM) total score : Absolute change from baseline to Week 12 in POEM total score
    9 : EASI50 (50% reduction in Eczema Area and Severity Index score) at Week 12 : Proportion of patients with EASI50 (reduction of EASI score by>/=50% from baseline) at Week 12
    10 : EASI75 (75% reduction in Eczema Area and Severity Index score) at Week12 : Proportion of patients with EASI75 (reduction of EASI score by >/=75% from baseline) at Week 12
    11 Change from baseline to Week 12 in Dermatology Life Quality Index (DLQI) total score : Absolute change from baseline to Week 12 in Dermatology Life Quality Index (DLQI) total score
    12 Change from baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment SF8a Total Score : Absolute change from baseline to Week 12 in PROMIS Sleep Related Impairment SF8a Total Score
    13 : Adverse events through Week 24 : Incidence of adverse events reported
    1. Variazione dal basale alla Settimana 12 nell’efficienza del sonno in base ai dati actigrafici. Assoluta Variazione dal basale alla Settimana 12 nell’efficienza del sonno basata su dati actigrafici. L’efficienza del sonno è calcolata come proporzione di tempo speso stando svegli vs il tempo totale a letto, espresso come percentuale.Questo è valutato giornalmente e la media settimanale è usata per le analisi.
    2. Variazione dal basale alla Settimana 12 nel tempo totale di sonno basato su dati actigrafici. Assoluta variazione dal basale alla Settimana 12 nel tempo totale di sonno basato su dati actigrafici. Il tempo totale di sonno è valutato giornalmente; la media settimanale è usata per le analisi
    3. Variazione dal basale alla Settimana 12 nel tempo di veglia dopo l’addormentamento in base ai dati actigrafici. Assoluta variazione dal basale alla Settimana 12 nel tempo di veglia dopo l’addormentamento in base ai dati actigrafic (WASO)i. Il tempo di veglia dopo l’addormentamento è valutato giornalmente; la media settimanale è usata per le analisi
    4. Variazione dal basale alla Settimana 12 nella latenza di addormentamento in base a dati actigrafici. Assoluta variazione dal basale alla Settimana 12 nella latenza di addormentamento in base a dati actigrafici. la latenza di addormentamento è valutato giornalmente; la media settimanale è usata per le analisi
    5. Variazione percentuale dal basale alla Settimana 12 nel punteggio per il prurito. Percentuale dal basale alla Settimana 12 nel punteggio per il prurito. Il prurito è valutato giornalmente usando la scala di valutazione numerica; la media settimanale è usata per le analisi.
    6. Variazione rispetto al basale alla Settimana 12 nel punteggio totale SCORing Atopic Dermatitis (SCORAD). Assoluta Variazione rispetto al basale alla Settimana 12 nel punteggio totale SCORing Atopic Dermatitis (SCORAD)
    7. Variazione dal basale alla Settimana 12 nella scala analogica visiva (VAS) del sonno SCORAD. Assoluta variazione dal basale alla Settimana 12 nella scala analogica visiva (VAS) del sonno SCORAD.
    8. Variazione dal basale alla Settimana 12 nel punteggio totale del questionario di valutazione dell’eczema da parte del paziente (POEM). Assoluta variazione dal basale alla Settimana 12 nel punteggio totale del questionario di valutazione dell’eczema da parte del paziente (POEM)
    9. EASI50 ( 50% di riduzione nel punteggio Eczema Area and Severity Index) alla settimana 12 . proporzione di pazienti con EASI50 (riduzione del punteggio EASI >/= 50% rispetto al basale) alla Settimana 12
    10. EASI75 ( 75% di riduzione nel punteggio Eczema Area and Severity Index) alla settimana 12 . proporzione di pazienti con EASI75 (riduzione del punteggio EASI >/= 75% rispetto al basale) alla Settimana 12
    11. Variazione dal basale alla Settimana 12 nel punteggio totale dell’indice dermatologico della qualità di vita (DLQI). Assoluta variazione dal basale alla Settimana 12 nel punteggio totale dell’indice dermatologico della qualità di vita (DLQI).
    12. Variazione rispetto al basale alla Settimana 12 nel punteggio totale del questionario PROMIS SF8a sui problemi correlati al sonno. Assoluta variazione rispetto al basale alla Settimana 12 nel punteggio totale del questionario PROMIS SF8a sui problemi correlati al sonno.
    13. Eventi avversi fino alla Settimana 24: incidenza di eventi avversi segnalati
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 : Baseline to Week 12
    13 : From the signing of Informed consent to resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up
    1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 :DAL BASALE ALLA SETTIMANA 12
    13:Dalla firma del consenso informato alla risoluzione, alla stabilizzazione, l'evento è altrimenti spiegato, o il partecipante è perso al follow-up
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    12 settimane in doppio cieco, seguite da 12 settimane in aperto
    12 weeks Double-Blind, followed by 12 weeks Open-Label
    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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    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
    Israel
    United Arab Emirates
    United States
    France
    Germany
    Italy
    Spain
    Switzerland
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    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 months4
    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: 253
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 268
    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
    NESSUNO
    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 Decision2020-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
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