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    Summary
    EudraCT Number:2018-004073-27
    Sponsor's Protocol Code Number:18082A0002
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-004073-27
    A.3Full title of the trial
    Dupilumab impact on skin resident memory T cells
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dupilumab impact on skin resident memory T cells
    A.3.2Name or abbreviated title of the trial where available
    DupiTrem
    A.4.1Sponsor's protocol code number18082A0002
    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 SponsorARCI (trade name LYON RECHERCHE CLINIQUE : LyREC)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportARCI (trade name LYON RECHERCHE CLINIQUE : LyREC)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARCI (trade name LYON RECHERCHE CLINIQUE : LyREC)
    B.5.2Functional name of contact pointClinical Research Unit
    B.5.3 Address:
    B.5.3.1Street AddressCentre Hospitalier Lyon Sud – Pav 1 K – 165 chemin du Grand Revoyet
    B.5.3.2Town/ cityPierre-Bénite
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+330478861859
    B.5.5Fax number+330472666471
    B.5.6E-mailsophie.gilibert@lyonrechercheclinique.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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) 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 Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Betneval 0.1% cream
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Dermoval 0.05% cream
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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
    Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic Dermatitis
    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 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
    To phenotype the immune cells that are present in the skin and the blood of AD patients (D0) and persist one and six months after dupilumab or TCS treatment (D28 and D168).
    E.2.2Secondary objectives of the trial
    - To correlate the phenotype of immune cells present in the skin and the blood at D0, D28 and D168, and the magnitude of clinical symptoms (as measured using IGA, EASI, SCORAD, lesional area score and life quality index (DLQI))
    - To correlate the phenotype of immune cells present in the skin and the blood, and the clinical efficacy of dupilumab and TCS treatments (together and individually) at D28 and D168.
    - To correlate the phenotype of immune cells present in the skin and the blood at D0, D28 and D168, and the frequency of AD relapse during the 3 months follow-up period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject over 18 years of age
    • For woman with childbearing potential ;
    • Use of a highly effective method of birth control from at least 1 month prior to study enrollment until the last visit
    • Negative urine pregnancy test at inclusion visit
    • Subject diagnosed with moderate-to-severe AD, defined as SCORAD≥20 and/or EASI≥7 (Eichenfield et al., 2014)
    • Subject with I, II, III or IV skin phototype (according to Fitzpatrick scale)
    • Subject accepting skin prick-tests and skin biopsies
    • Subject having a least one non lesional area on the body (off head and neck, feet and hands)
    • Subject eligible for systemic treatment
    • Failure, intolerance or contraindication to available systemic treatments (i.e. cyclosporine/ methotrexate)
    E.4Principal exclusion criteria
    • Pregnancy or breast-feeding women, or planning to become pregnant or breastfeed during the study
    • Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of AD
    • History of allergic reaction to local anesthetic product
    • History of wound healing disorders (e.g. hypertrophic scars, keloids)
    • Subject with known active infection to HBV, HCV or HIV
    • Subject with known blood dyscrasia
    • Subject having an allergen immunotherapy within 3 months before study
    • Subject treated by antihistamine 5 days before study. Please note, antihistamine administered to treat allergic rhino conjunctivitis is allowed after V1.
    • Subject treated with an investigational drug within 8 weeks or within 5 half-life (if known), whichever is longer, before the baseline visit
    • Subject treated with cyclosporine, methotrexate oral corticosteroids, azathioprine, mycophenolate-mofetil, and/or any other systemic immunosupperessor/immunomodulator within 4 weeks before the study
    • Subject treated by a biologic therapy within 5 half-life before the study
    • Subject treated with ultraviolet therapy within 4 weeks before study
    • Subject treated with a live (attenuated) vaccine within 12 weeks before baseline visit
    E.5 End points
    E.5.1Primary end point(s)
    We will follow the evolution of the number (per biopsy or per mL of blood) and/or frequency (among live hematopoietic cells CD45+) of the following populations:
    - CD8+ T cells (TCRab+ CD8b+),
    - CD4+FoxP3- T cells (TCRab+ CD4+ FoxP3-),
    - Tregs (TCRab+ CD4+ FoxP3+),
    - B cells (CD19+ HLADR+),
    - gd T cells (TCRgd+),
    - iNKT (TCRabint CD161+ TCRVa24+ CD56+),
    - NK cells (CD56+ NKP46+ CD14- CD16+ CD7+),
    - ILC (Lineage- CD94- CD34- CD127+ CRTH2+/- NKP44+/- CD103+/-),
    - Neutrophils (CD16+ CD66a+ CD66b+ CRTH2-),
    - Eosinophils (CD16low CD66b+ CRTH2+),
    - Basophils (CD19- HLADR- FcRI+ CD123+ CRTH2+),
    - Mast cells (HLADR- CD123- FcRI+ CD117+),
    - Langerhans cells (CD207+ HLADR+ CD11clow),
    - plasmacytoid DCs (HLADR+ CD123+ CRTH2+ BDCA2+),
    - cDC1 (HLADR+ CD11c+ XCR1+ CD14- CD16-),
    - cDC2 (HLADR+ CD11c+ SIRPa+ CD14- CD16-),
    - Monocytes (HLADR+/- CD11c+ CD14+/- CD16+/-),
    - Macrophages (HLADR+/- CD11c+/- CD64+ F4/80+),
    - TH2 Trm cells (TCRab+ CD4+ CD103+/- CD69+/- CD49a+/- CCR7- GATA-3+ Tbet-RORt- IL-4+/- IL-13+/- IL-5+/-),
    - ILC2 (Lineage- CD103+/- CD69+/- CD49a+/- CCR7- CD94- CD34- CD127+ CRTH2+ IL-4+/- IL-13+/- IL-5+/-),
    - IL-4/IL-13-producing hematopoietic cells (CD45+ IL-4+/- IL-13+/-),
    - Other Trm cells (TCRab+ CD4- CD8+/- CD103+/- CD69+/- CD49a+/- CCR7- Tbet+/- RORt+/- IFN+/- TNF+/- IL17a+/- IL4+/- IL-13+/- IL-5+/- IL-9+/- IL-10+/- IL-21+/- IL-22+/- IL-31+/-).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, day 28 and day 168.
    E.5.2Secondary end point(s)
    Endpoints for secondary objective 1:
    Correlations will be searched between each immunological parameter and:
    - each clinical score (IGA, EASI, SCORAD, lesional area score) and their evolution as a continuous quantitative variable,
    - quality of life index as a continuous quantitative variable.
    Then, correlations will also be searched between a cluster of relevant immunological parameters and clinical parameters cited above.
    Endpoints for secondary objective 2:
    Correlations will be searched between each immunological parameter and:
    - change in clinical score (IGA, EASI, SCORAD), as a qualitative variable with 2 modalities (good responders vs bad responders)
    - quality of life index, as a qualitative variable with 2 modalities (good responders vs bad responders)
    Then, correlations will also be searched between a cluster of relevant immunological parameters and clinical parameters cited above.
    During this study, all patients reaching the following criteria will be considered as good responders:
    - 1st criteria: IGA ≤1 or a 2-point change from the baseline IGA
    - 2nd criteria: EASI75 (75% improvement from the baseline EASI)
    - 3rd criteria: SCORAD75 (75% improvement from the baseline SCORAD)
    - 4th criteria: 4-point decrease from the baseline DLQI.
    Correlations will be searched between each immunological parameter and:
    - the development of new AD lesions in the 3 following months, as qualitative variable with 2 modalities (relapse vs not relapse),
    - the interval of time between the end of treatment and AD relapse, as a continuous variable.
    Then, correlations will be also searched between a cluster of relevant immunological parameters and clinical parameters cited above.
    AD relapse will be defined as the necessity to re-apply rescues TCS for patients with IGA≤1 at the end of the treatment period (6 months).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, day 28 and day 168.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Physiopathological exploratory study.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    E.8.9.1In the Member State concerned days
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state20
    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)
    No exclusion period is planned after the end of the study. At end of the study, patient will be provided with treatment and care adapted to their medical state.
    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 Decision2019-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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