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    Summary
    EudraCT Number:2020-002962-15
    Sponsor's Protocol Code Number:LP0133-1403
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-06
    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 ConcernedFrance - ANSM
    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)
    Essai clinique de phase 3, extension des essais DELTA 1 et DELTA 2, pour évaluer l'innocuité à long terme d'un traitement avec la crème de delgocitinib à 20 mg/g appliqué deux fois par jour selon les besoins pendant une durée maximale de 36 semaines chez des sujets adultes atteints d'eczéma chronique des mains (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
    Essai d'extension multicentrique en ouvert chez des patients ayant terminé les essais LP0133-1401 (DELTA 1) ou LP0133-1402 (DELTA 2)
    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.3.9.3Other descriptive nameLEO 124249A, JTE052
    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 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 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 Chronique des mains
    E.1.1.1Medical condition in easily understood language
    Hand Eczema
    Eczema des mains
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    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 twice-daily applications of delgocitinib cream 20 mg/g.
    Évaluer la sécurité à long terme d'un traitement à la demande avec des applications biquotidiennes de la crème de delgocitinib à 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.
    Évaluer l'efficacité à long terme d'un traitement à la demande avec des applications biquotidiennes de la crème de delgocitinib à 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.
    - Formulaire de consentement éclairé daté et signé avant toute procédure figurant au protocole.
    - La visite d'inclusion dans cet essai d'extension doit coïncider avec la visite de la semaine 16 (visite de fin de traitement) dans l'essai parent.
    -Les patients doivent avoir satisfait aux critères d'admissibilité lors de la sélection et de l'inclusion dans l'essai parent.
    - Les patients doivent avoir terminé la période de traitement dans l'essai parent (à évaluer lors de la visite d'inclusion dans cet essai d'extension).
    - Les patients doivent avoir respecté le protocole d’essai clinique de l’étude parent selon l'avis de l’investigateur.
    - Les femmes en âge de procréer* doivent utiliser une méthode contraceptive acceptable** tout au long de l'essai jusqu'à la visite de fin de traitement/d'arrêt prématuré.
    - Pour la France, les patients devront bénéficier d’un régime de sécurité sociale.
    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.
    - Patients ayant interrompu prématurément le traitement par le ME ou ayant commencé un traitement de secours dans l'essai parent.
    -Les patients ayant présenté un quelconque événement indésirable (EI) au cours de la participation à l'essai parent, qui, selon le jugement de l'investigateur, empêche la poursuite du traitement par la crème de delgocitinib à 20 mg/g.
    - Tout état médical ou psychiatrique qui pourrait faire courir un risque excessif au patient en participant à l'essai, ou qui, selon le jugement de l'investigateur, rend le patient inapproprié pour participer à l'essai.
    -Participation en cours à une autre étude clinique interventionnelle, à l'exception de l'essai parent.
    E.5 End points
    E.5.1Primary end point(s)
    Number of treatment-emergent AEs from baseline up to Week 38.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 38
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint for evaluation described in each 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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned12
    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 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
    Russian Federation
    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
    Last visit of the last subject - LVLS
    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 state53
    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
    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 Decision2021-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-18
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