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    Summary
    EudraCT Number:2020-001518-40
    Sponsor's Protocol Code Number:LPS16764
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-08-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-001518-40
    A.3Full title of the trial
    Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in pediatric patients with moderate to severe atopic dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dupilumab-PEdiatric skin barrier function and LIpidomics STudy in patients with Atopic Dermatitis
    A.3.2Name or abbreviated title of the trial where available
    PELISTAD
    A.4.1Sponsor's protocol code numberLPS16764
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1244-1409
    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 Recherche & Developpement
    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 Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis Recherche & Développement
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street Address410 Thames Valley Park Drive
    B.5.3.2Town/ cityReading
    B.5.3.3Post codeRG6 1PT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448450230441
    B.5.6E-mailuk-medicalinformation@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 in pre-filled syringe
    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 milligram(s)
    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 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 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.IMP: 2
    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 in pre-filled syringe
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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 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
    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 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
    Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric patients with moderate to severe atopic dermatitis (AD) treated with dupilumab
    E.2.2Secondary objectives of the trial
    Evaluate changes in skin barrier function with TEWL assessed after STS in predefined lesional and non lesional skin in pediatric patients with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers.
    Evaluate time course of change in skin barrier function with TEWL assessed before and after STS in predefined lesional and non-lesional skin in pediatric patients with moderate to severe AD during dupilumab treatment phase and follow-up period in reference to normal skin of healthy volunteers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be between ≥6 to <12 years of age (inclusive), at the time of signing the informed consent
    - 15 kg ≤ body weight <60 kg.
    Atopic dermatitis patients:
    - Male or female pediatric patients.
    - Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
    -Investigator Global Assessment (IGA) score of ≥3 (for US patients) or IGA ≥4 (for EU patients) at screening (on the 0-4 scale) depending on approved label indication in the country.
    - Patients with moderate to severe AD those are eligible to be treated with dupilumab according to product label.
    - Patients with AD must have active lesions on the upper limbs or lower limbs (including trunk, if needed), with severity for lesion erythema or edema/papulation ≥2 at screening on the 0-3 scale of the ISS.
    - Participants should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible.
    Healthy volunteers:
    - Age and gender matched (match on age ±2 years) to a selected AD patient by study site.
    E.4Principal exclusion criteria
    - Previous treatment with dupilumab within 6 months prior to screening.
    - Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the Investigator (ie, skin atrophy, ichthyosis, tinea infection, contact dermatitis).
    - Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments.
    - Hypersensitivity to the active substance or to any of the excipients of dupilumab.
    - Ocular disorder that in the opinion of the Investigator could adversely affect the individual’s risk for study participation. Examples include -but are not limited to- individuals with a history of active cases of herpes keratitis; Sjogren’s syndrome, keratoconjunctivitis sicca, or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine.
    - Healthy volunteers with a personal history of an atopic condition.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in TEWL after 5 STS assessed on lesional skin in AD patients ; Percent change from baseline in TEWL after 5 STS assessed on lesional skin in AD patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 16
    E.5.2Secondary end point(s)
    1 - Percent change from baseline in TEWL after 20 STS assessed on lesional skin in AD patients.
    Absolute change from baseline in TEWL after 20 STS assessed on lesional skin in AD patients
    2 - Percent change from baseline in TEWL after 20 STS assessed on non-lesional skin in AD patients.
    Absolute change from baseline in TEWL after 20 STS assessed on non-lesional skin in AD patients.
    3 - Percent change from baseline in TEWL after 20 STS assessed on normal skin in healthy volunteers
    Absolute change from baseline in TEWL after 20 STS assessed on normal skin in healthy volunteers
    4 - Percent change from baseline in TEWL after 15 STS assessed on lesional skin in AD patients.
    Absolute change from baseline in TEWL after 15 STS assessed on lesional skin in AD patients.
    5 - Percent change from baseline in TEWL after 15 STS assessed on non-lesional skin in healthy volunteers
    Absolute change from baseline in TEWL after 15 STS assessed on non-lesional skin in healthy volunteers
    6 - Percent change from baseline in TEWL after 15 STS assessed on normal skin in healthy volunteers
    Absolute change from baseline in TEWL after 15 STS assessed on normal skin in healthy volunteers
    7 - Percent change from baseline in TEWL after 10 STS assessed on lesional skin in AD patients.
    Absolute change from baseline in TEWL after 10 STS assessed on lesional skin in AD patients
    8 - Percent change from baseline in TEWL after 10 STS assessed on non-lesional skin in AD patients.
    Absolute change from baseline in TEWL after 10 STS assessed on non- lesional skin in AD patients
    9 - Percent change from baseline in TEWL after 10 STS assessed on normal skin in healthy volunteer
    Absolute change from baseline in TEWL after 10 STS assessed on normal skin in healthy volunteer
    10 - Percent change from baseline in TEWL after 5 STS assessed on non-lesional skin in AD patients
    Absolute change from baseline in TEWL after 5 STS assessed on non-lesional skin in AD patients
    11 - Percent change from baseline in TEWL after 5 STS assessed on normal skin in healthy volunteers
    Absolute change from baseline in TEWL after 5 STS assessed on normal skin in healthy volunteers
    12 - Percent change in TEWL before STS on lesional skin in AD patients over time.
    Absolute change in TEWL before STS on lesional skin in AD patients over time
    13 - Percent change in TEWL before STS on non-lesional skin in AD patients over time.
    Absolute change in TEWL before STS on non-lesional skin in AD patients over time.
    14 - Percent change in TEWL before STS on normal skin in healthy volunteers over time
    Absolute change in TEWL before STS on normal skin in healthy volunteers overtime
    15 - Percent change in TEWL area under the curve (TEWL AUC: a composite measure before and after 5, 10, 15, and 20 STS) for skin barrier function in lesional skin in AD patients over time.
    Absolut change in TEWL area under the curve (TEWL AUC: a composite measure before and after 5, 10, 15, and 20 STS) for skin barrier function in lesional skin in AD patient overtime
    16 - Percent change in TEWL AUC (a composite measure before and after 5, 10, 15, and 20 STS) for skin barrier function in non-lesional skin in AD patient over time.
    Absolute change in TEWL AUC (a composite measure before and after 5, 10, 15, and 20 STS) for skin barrier function in non-lesional skin in AD patient over time
    17 - Percent change in TEWL AUC (a composite measure before and after 5, 10, 15, and 20 STS) for skin barrier function in normal skin in healthy volunteers over time
    Absolute change in TEWL AUC (a composite measure before and after 5, 10, 15, and 20 STS) for skin barrier function in normal skin in healthy volunteers over time
    18 - Percent change in TEWL after STS assessed on lesional skin in AD patients over time.
    Absolute change in TEWL after STS assessed on lesional skin in AD patients over time.
    19 - Percent change in TEWL after STS assessed on non-lesional skin in AD patients over time.
    Absolute change in TEWL after STS assessed on non-lesional skin in AD patients over time.
    20 - Percent change in TEWL after STS assessed on normal skin in healthy volunteers over time.
    Absolute change in TEWL after STS assessed on normal skin in healthy volunteers over time.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 : Baseline to week 16
    12, 13, 14, 15, 16, 17, 18, 19, 20 : Baseline to week 28
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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
    United Kingdom
    United States
    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 months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 48
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants between 6 to 11 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 48
    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 Decision2020-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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