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    Summary
    EudraCT Number:2020-002960-30
    Sponsor's Protocol Code Number:LP0133-1401
    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:2021-08-30
    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 number2020-002960-30
    A.3Full title of the trial
    A phase 3 clinical trial to confirm efficacy and evaluate safety of twice-daily delgocitinib cream 20 mg/g compared with cream vehicle for a 16-week treatment period in adult subjects with moderate to severe chronic hand
    eczema (DELTA 1)
    Studio clinico di fase 3 per confermare l'efficacia e valutare la sicurezza di delgocitinib crema 20 mg/g due volte al giorno rispetto alla crema veicolo per un periodo di trattamento di 16 settimane in soggetti adulti con eczema cronico alle mani da moderato a grave (DELTA 1).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema.
    Efficacia e sicurezza di delgocitinib crema negli adulti con eczema cronico alle mani da moderato a grave.
    A.3.2Name or abbreviated title of the trial where available
    DELTA-1
    DELTA-1
    A.4.1Sponsor's protocol code numberLP0133-1401
    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 support
    B.4.2Country
    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.5.4Telephone number000000
    B.5.5Fax number000000
    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.2.1.1.1Trade name Delgocitinib cream
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    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 della mano
    E.1.1.1Medical condition in easily understood language
    Hand eczema
    Eczema della mano
    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 confirm the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult subjects with moderate to severe CHE
    Confermare l'efficacia delle applicazioni due volte al giorno di delgocitinib crema 20 mg/g rispetto alla crema veicolo nel trattamento di soggetti adulti con CHE da moderato a grave.
    E.2.2Secondary objectives of the trial
    - To confirm the health-related quality of life and efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult subjects with moderate to severe CHE.
    - To evaluate the safety of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult subjects with moderate to severe CHE.
    - Confermare la qualità della vita correlata alla salute e l'efficacia delle applicazioni due volte al giorno di delgocitinib crema 20 mg/g rispetto alla crema veicolo nel trattamento di soggetti adulti con CHE da moderato a grave.
    - Valutare la sicurezza delle applicazioni due volte al giorno di delgocitinib crema 20 mg/g rispetto alla crema veicolo nel trattamento di soggetti adulti con CHE da moderato a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 years or above at screening.
    • Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
    • Disease severity graded as moderate to severe at screening and baseline according to IGA CHE (i.e. an IGA CHE score of 3 or 4).
    • HESD itch score (weekly average) of =4 points at baseline.
    • Subjects who have a documented recent history of inadequate response to treatment with TCS (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
    • Subjects adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
    • A woman of childbearing potential must use at least an acceptable method of birth control throughout the trial up until the last application of IMP.
    • Età pari o superiore a 18 anni allo screening.
    • Diagnosi di CHE, definito come eczema alle mani che persiste da più di 3 mesi o che si è ripresentato due o più volte negli ultimi 12 mesi.
    • Gravità della malattia classificata da moderata a grave allo screening e al basale secondo l'IGA-CHE (ovvero un punteggio IGA-CHE di 3 o 4).
    • Punteggio HESD del prurito (media settimanale) =4 punti al basale.
    • Soggetti che presentano un'anamnesi recente documentata di risposta inadeguata al trattamento con corticosteroidi topici (CST) (in qualsiasi momento nell'anno precedente alla visita di screening) o per i quali sia
    documentato che i CST siano altrimenti sconsigliabili dal punto di vista medico (ad esempio a causa di importanti effetti collaterali o rischi per la sicurezza).
    • Soggetti aderenti alla cura della pelle standard non farmacologica,incluso l'evitare l'uso di sostanze irritanti e allergeni noti e rilevanti.
    • Una donna in età fertile deve utilizzare almeno un metodo di controllo delle nascite accettabile durante tutto lo studio fino all'ultima applicazione di IMP.
    E.4Principal exclusion criteria
    -Concurrent skin diseases on the hands, e.g. tinea manuum.
    -Active AD requiring medical treatment in regions other than the hands and feet.
    -Active psoriasis on any part of the body.
    -Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
    -Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
    -Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid
    eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
    -Use of tanning beds, phototherapy (e.g. UVB, UVA1, PUVA), or bleach baths on the hands within 28 days prior to baseline.
    -Previous or current treatment with JAK inhibitors (including delgocitinib/ LEO 124249), systemic or topical.
    -Cutaneously applied treatment with immunomodulators (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline.
    -Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
    -Other transdermal or cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline.
    -Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
    -Treatment with any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, and dupilumab)
    •Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
    •Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
    -Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the
    subject's ability to participate in the trial. Clinically significant infections are defined as
    •A systemic infection.
    •A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
    -History of any known primary immunodeficiency disorder including a positive HIV virus test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal
    report.
    -Any disorder which is not stable and could:
    •Affect the safety of the subject throughout the trial.
    •Impede the subject's ability to complete the trial.
    Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, and major physical impairment.
    -Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.
    • Malattie della pelle concomitanti sulle mani, ad esempio tinea manuum.
    • Dermatite atopica (DA) attiva che richieda un trattamento medico in aree diverse da mani e piedi.
    • Psoriasi attiva in qualsiasi parte del corpo.
    • Eczema ipercheratosico alle mani in combinazione con un'anamnesi di psoriasi in qualsiasi parte del corpo.
    • Infezione clinicamente significativa (ad esempio eczema impetiginoso) alle mani.
    • Trattamento sistemico con farmaci immunosoppressori (ad esempio metotrexato, ciclosporina, azatioprina), farmaci immunomodulatori, retinoidi (ad esempio alitretinoina) o corticosteroidi nei 28 giorni
    precedenti al basale (sono ammessi colliri steroidei e steroidi inalatori o intranasali corrispondenti a un massimo di 1 mg di prednisolone per congiuntivite allergica, asma o rinite).
    • Uso di lettini abbronzanti, fototerapia (ad esempio UVB, UVA1, PUVA) o bagni in candeggina alle mani nei 28 giorni precedenti al basale.
    • Trattamento precedente o in atto con inibitori JAK (incluso delgocitinib/LEO 124249), sistemici o topici.
    • Trattamento applicato per via cutanea con immunomodulatori (ad esempio inibitori delle PDE-4, pimecrolimus, tacrolimus) o corticosteroidi topici sulle mani nei 14 giorni precedenti al basale.
    • Uso di antibiotici sistemici o applicati per via cutanea sulle mani nei 14 giorni precedenti al basale.
    • Altra terapia transdermica o cutanea applicata sulle mani (eccetto l'uso di emollienti del soggetto) nei 7 giorni precedenti al basale.
    • Trattamenti applicati per via cutanea in aree diverse dalle mani, che potrebbero interferire con le valutazioni dello studio clinico o rappresentare un problema per la sicurezza nei 7 giorni precedenti al basale.
    • Trattamento con qualsiasi terapia biologica in commercio o farmaco biologico sperimentale (inclusi immunoglobuline, anti-IgE e dupilumab):
    o Qualsiasi agente di deplezione delle cellule, tra cui rituximab: nei 6 mesi precedenti al basale o fino a quando la conta linfocitaria non ritorni alla normalità, a seconda di quale sia il periodo più lungo.
    o Altri agenti biologici: nei 3 mesi o nelle 5 emivite, a seconda di quale sia il periodo più lungo, precedenti al basale.
    • Infezione clinicamente significativa nei 28 giorni precedenti al basale che, secondo il parere dell'Investigator (sperimentatore), potrebbe compromettere la sicurezza del soggetto nello studio, interferire con la
    valutazione dell'IMP o ridurre la capacità di partecipazione del soggetto allo studio. Le infezioni clinicamente significative sono definite come:
    o Infezione sistemica.
    o Grave infezione della pelle che richieda il trattamento per via parenterale (per via endovenosa o intramuscolare) con antibiotici, antivirali o antimicotici.
    • Anamnesi di qualsiasi disturbo accertato da immunodeficienza primaria, comprendente un test per HIV positivo allo screening o l'assunzione da parte del soggetto di farmaci antiretrovirali come determinato dall'anamnesi medica e/o riferito verbalmente dal soggetto.
    • Qualsiasi disturbo che non sia stabile e che potrebbe:
    o Influire sulla sicurezza del soggetto durante lo studio.
    o Compromettere la capacità del soggetto di completare lo studio.
    Gli esempi includono, tra gli altri, i disturbi cardiovascolari, gastrointestinali, epatici, renali, neurologici, muscoloscheletrici, infettivi, endocrini, metabolici, ematologici, immunologici e psichiatrici nonché grave compromissione fisica.
    • Sierologia positiva per l'antigene di superficie dell'epatite B o per gli anticorpi del virus dell'epatite C allo screening.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    IGA-CHE TS at Week 16
    Endpoint primario:
    IGA-CHE TS alla Settimana 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Settimana 16
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    • HECSI 75 at Week 16.
    • HECSI 75 at Week 8.
    • HECSI 90 at Week 16.
    • IGA CHE TS at Week 8.
    • IGA CHE TS at Week 4.
    • Percentage change in HECSI score from baseline to Week 16.
    Endpoint chiave secondari:
    • HECSI 75 alla settimana 16.
    • HECSI 75 alla settimana 8.
    • HECSI 90 alla settimana 16.
    • IGA CHE TS alla settimana 8.
    • IGA CHE TS alla settimana 4.
    • Variazione percentuale del punteggio HECSI dal basale alla settimana 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between Week 0 and 16, as specified for each endpoint
    Tra la settimana 0 e la 16, come specificato per ogni 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 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) 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days16
    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: 405
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 348
    F.4.2.2In the whole clinical trial 450
    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)
    Eligible subjects who complete the Week 16 visit (and who do not permanently discontinue IMP prior to Week 16) will be invited to continue in the LTE trial (conducted under a separate clinical trial protocol)
    I soggetti idonei che completano la visita della settimana 16 (e che non interrompono definitivamente l'IMP prima della settimana 16) saranno invitati a continuare lo studio LTE (condotto secondo un protocollo di sperimentazione clinica separato)
    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 Decision2021-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-24
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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