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    Summary
    EudraCT Number:2020-002962-15
    Sponsor's Protocol Code Number:LP0133-1403
    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:2021-10-07
    Trial 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 number2020-002962-15
    A.3Full title of the trial
    A phase 3 extension trial of DELTA 1 and DELTA 2 to evaluate the long-term
    safety of a twice-daily treatment with delgocitinib cream 20 mg/g as
    needed for up to 36 weeks in adult subjects with chronic hand eczema
    (DELTA 3)
    Studio di estensione di fase 3 di DELTA 1 e DELTA 2 per valutare la
    sicurezza a lungo termine di un trattamento due volte al giorno con
    delgocitinib crema 20 mg/g al bisogno fino a 36 settimane in soggetti adulti
    con eczema cronico alle mani (DELTA 3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label multi-site extension trial in subjects who completed the
    LP0133-1401 (DELTA 1) or LP0133-1402 (DELTA 2) trials
    Uno studio di estensione multicentrico in aperto in soggetti che hanno completato gli studi LP0133-1401 (DELTA 1) o LP0133-1402 (DELTA 2)
    A.3.2Name or abbreviated title of the trial where available
    DELTA-3
    DELTA-3
    A.4.1Sponsor's protocol code numberLP0133-1403
    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 pointGlobal Regulatory Affairs
    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-mailraleodk@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 nameDelgocitinib cream
    D.3.2Product code [LEO 124249]
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdelgocitinib
    D.3.9.1CAS number 1263774-59-9
    D.3.9.2Current sponsor codeLEO 124249
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hand Eczema
    eczema cronico alle mani
    E.1.1.1Medical condition in easily understood language
    Hand Eczema
    eczema alle mani
    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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084778
    E.1.2Term Chronic hand eczema
    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 long-term safety of an as-needed treatment with twicedaily
    applications of delgocitinib cream 20 mg/g.
    Valutare la sicurezza a lungo termine
    di un trattamento al bisogno con
    applicazioni due volte al giorno di
    delgocitinib crema 20 mg/g.
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy of an as-needed treatment with
    twice-daily applications of delgocitinib cream 20 mg/g.
    Valutare l'efficacia a lungo termine di
    un trattamento al bisogno con
    applicazioni due volte al giorno di
    delgocitinib crema 20 mg/g.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated informed consent has been obtained prior to any
    protocol related procedures.
    • The baseline visit in this extension trial must coincide with the Week
    16 (end-of-treatment) visit in the parent trial.
    • Subjects must have met eligibility criteria at screening and baseline in
    the parent trial.
    • Subjects must have completed the treatment period in the parent trial
    (to be assessed at baseline visit in this extension trial).
    • Subjects must have complied with the clinical trial protocol in the
    parent trial to the satisfaction of the investigator.
    • A woman of childbearing potential must use an acceptable method of
    birth control throughout the trial up until the end-of-treatment/early
    termination visit.
    Il consenso informato firmato e datato è stato ottenuto prima di qualsiasi
    procedura relativa al protocollo.
    • La visita basale in questo studio di estensione deve coincidere con la
    visita della Settimana 16 (fine trattamento) nello studio originario
    I soggetti devono aver soddisfatto i criteri di idoneità allo screening e al
    basale nello studio originario.
    • I soggetti devono aver completato il periodo di trattamento nello studio
    originario (da valutare alla visita basale in questo studio di estensione).
    • I soggetti devono aver rispettato il protocollo dello studio clinico nello
    studio originario in maniera soddisfacente per lo sperimentatore.
    • Una donna in età fertile deve utilizzare un metodo accettabile di
    controllo delle nascite durante l'intero studio fino alla visita di fine
    trattamento/interruzione anticipata.
    E.4Principal exclusion criteria
    • Subjects who prematurely discontinued treatment with the
    investigational medicinal product (IMP) or initiated rescue medication in
    the parent trial.
    • Subjects who experienced any AE during participation in the parent
    trial, which precludes further treatment with delgocitinib cream 20 mg/g
    in the judgement of the investigator.
    • Any medical or psychiatric condition that could put the subject at
    undue risk by participating in the trial, or which, by the investigator's judgment, makes the subject inappropriate for the trial.
    • Current participation in any other interventional clinical trial, except
    for parent trials.
    Soggetti che hanno interrotto prematuramente il trattamento con il
    medicinale sperimentale (IMP) o che hanno iniziato un farmaco di
    salvataggio (rescue medication) nello studio originario.
    • Soggetti che hanno manifestato qualsiasi EA durante la partecipazione
    allo studio originario, che a giudizio dello sperimentatore precluda un
    ulteriore trattamento con delgocitinib crema 20 mg/g.
    • Qualsiasi condizione medica o psichiatrica che potrebbe esporre il
    soggetto a un rischio indebito a seguito della partecipazione allo studio
    o che, a giudizio dello sperimentatore, renda il soggetto inadatto allo
    studio.
    • Attuale partecipazione a qualsiasi altro studio clinico interventistico, ad
    eccezione degli studi originari.
    E.5 End points
    E.5.1Primary end point(s)
    Number of treatment-emergent AEs from baseline up to Week 38
    Numero di eventi avversi (EA)
    emergenti dal trattamento dal
    basale fino alla Settimana 38.
    E.5.1.1Timepoint(s) of evaluation of this end point
    38 weeks
    38 settimane
    E.5.2Secondary end point(s)
    IGA-CHE score at each scheduled visit from baseline up to Week 36.
    • IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit
    from baseline up to Week 36.
    • HECSI score at each scheduled visit from baseline up to Week 36.
    • HECSI-75 at each scheduled visit from baseline up to Week 36.
    • HECSI-90 at each scheduled visit from baseline up to Week 36.
    Punteggio IGA-CHE1 a ogni visita
    programmata dal basale fino alla
    Settimana 36.
    • Punteggio IGA-CHE di 0 (pelle
    intatta) o 1 (pressoché intatta) a
    ogni visita programmata dal basale
    fino alla Settimana 36.
    • Punteggio HECSI2 a ogni visita
    programmata dal basale fino alla
    Settimana 36.
    • Punteggio HECSI-75 a ogni visita
    programmata dal basale fino alla
    Settimana 36.
    • Punteggio HECSI-90 a ogni visita
    programmata dal basale fino alla
    Settimana 36
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint for evaluation described in each endpoint.
    Timepoint per la valutazione descritto in ciascun endpoint.
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Canada
    Belgium
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    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
    LPLV
    LPLV
    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 months1
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days2
    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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 485
    F.4.2.2In the whole clinical trial 600
    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 Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
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