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    Summary
    EudraCT Number:2016-004997-16
    Sponsor's Protocol Code Number:R668-AD-1652
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-004997-16
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of dupilumab administered concomitantly with topical corticosteroids in patients, ≥6 years to <12 years of age, with severe atopic dermatitis

    PIP number: P/069/2017
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized study to investigate the efficacy and safety of dupilumab administered with topical corticosteroids in patients ≥6 to <12 years with severe atopic dermatitis
    A.4.1Sponsor's protocol code numberR668-AD-1652
    A.5.4Other Identifiers
    Name:IND NumberNumber:107969
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/219/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 Yes
    D.2.1.1.1Trade name Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holderRegeneron Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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/REGN668
    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.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeSAR231893/REGN668
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB130625
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Yes
    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/REGN668
    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.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeSAR231893/REGN668
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB130625
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    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 / Eczema
    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 21.1
    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 demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in patients ≥6 years to <12 years of age with severe atopic dermatitis (AD).
    E.2.2Secondary objectives of the trial
    To assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to <12 years of age with severe AD.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Pharmacogenomic sub-study.
    E.3Principal inclusion criteria
    1. Male or female ≥6 to <12 years of age at time of screening visit
    2. Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
    3. Chronic AD diagnosed at least 1 year prior to the screening visit
    4. IGA = 4 at screening and baseline visits
    5. EASI ≥21 at the screening and baseline visits
    6. BSA ≥15% at screening and baseline visits
    7. Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
    8. At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily during the 7 consecutive days immediately before the baseline visit
    E.4Principal exclusion criteria
    1. Participation in a prior dupilumab clinical study
    2. Treatment with a systemic investigational drug before the baseline visit
    3. Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
    4. Treatment with crisabarole within 2 weeks prior to the baseline visit
    5. History of important side effects of medium potency topical corticosteroids (eg, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient’s treating physician
    6. Treatment with a TCI within 2 weeks prior to the baseline visit
    7. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
    a. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
    b. Phototherapy for AD
    8. Treatment with biologics, as follows:
    a. Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
    b. Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
    9. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
    10. Body weight <15 kg at baseline
    11. Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
    12. Regular use (more than 2 visits per week) of a tanning booth/parlor within 8 weeks of the baseline visit
    13. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit
    14. Established diagnosis of a primary immunodeficiency disorder
    15. History of past or current tuberculosis or other mycobacterial infection
    16. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit
    17. Established diagnosis of hepatitis B viral infection at the time of screening or is positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at the time of screening
    18. Established diagnosis of hepatitis C viral infection at the time of screening or is positive for hepatitis C antibody at the screening visit
    19. On current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis, or hepatic failure, or has evidence of liver disease as indicated by persistent (confirmed by repeated tests ≥2 weeks apart) elevated transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) more than 3 times the upper limit of normal (ULN) during the screening period
    20. Presence of any 1 or more of the following abnormalities in laboratory test results at screening:
    • Platelets ≤100 × 103/μL
    • Neutrophils <1.5 × 103/μL
    • Creatine phosphokinase (CPK) >5 × ULN
    • Serum creatinine >1.5 × ULN
    21. Presence of skin comorbidities that may interfere with study assessments. This includes, but is not limited to, conditions like scabies, seborrheic dermatitis, cutaneous T cell lymphoma, psoriasis, etc.
    22. History of malignancy before the baseline visit
    23. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
    24. Severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients with EASI-75 (≥75% improvement from baseline) at week 16
    2. Proportion of patients with IGA 0 or 1 (on a 5-point scale) at week 16


    E.5.1.1Timepoint(s) of evaluation of this end point
    Ad 1: at week 16
    Ad 2: at week 16
    E.5.2Secondary end point(s)
    Key secondary endpoints
    1. Percent change in EASI score from baseline to week 16
    2. Percent change from baseline to week 16 in weekly average of daily worst itch score

    Other secondary endpoints:
    1. Change from baseline to week 16 in weekly average of daily worst itch score
    2. Proportion of patients with EASI-50 at week 16
    3. Proportion of patients with EASI-90 at week 16
    4. Change from baseline to week 16 in percent Body Surface Area (BSA) affected by AD
    5. Percent change from baseline to week 16 in SCORing AD (SCORAD)
    6. Proportion of patients with improvement (reduction) of weekly average of daily worst itch score ≥4 from baseline at week 16
    7. Proportion of patients with improvement (reduction) of weekly average of daily worst itch score ≥3 from baseline at week 16
    8. Time to onset of effect on pruritus during the 16-week treatment period (≥4 point reduction of weekly average of daily worst itch score from baseline)
    9. Time to onset of effect on pruritus during the 16-week treatment period (≥3 point reduction of weekly average of daily worst itch score from baseline)
    10. Change from baseline to week 16 in Children’s Dermatology Life Quality Index (CDLQI)
    11. Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM)
    12. Change from baseline to week 16 in Dermatitis Family Index (DFI)
    13. Change from baseline to week 16 in Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric anxiety short form scale score
    14. Change from baseline to week 16 in PROMIS pediatric depressive symptoms short form scale score
    15. Topical treatment for AD – proportion of TCS medication-free days from baseline to week 16
    16. Mean weekly dose of TCS in grams for low and medium potency TCS from baseline to week 16
    17. Mean weekly dose of TCS in grams for high potency TCS from baseline to week 16
    18. Incidence of skin-infection treatment-emergent adverse events (TEAEs) (excluding herpetic infections) through week 16
    19. Incidence of serious TEAEs through week 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    The key secondary endpoints:
    Ad 1: from baseline to week 16
    Ad 2: baseline to week 16

    Other secondary endpoints:
    Ad 1: from baseline to week 16
    Ad 2: at week 16
    Ad 3: at week 16
    Ad 4: from baseline to week 16
    Ad 5: from baseline to week 16
    Ad 6: from baseline to week 16
    Ad 7: from baseline to week 16
    Ad 8: from baseline to week 16
    Ad 9: from baseline to week 16
    Ad 10: from baseline to week 16
    Ad 11: from baseline to week 16
    Ad 12: from baseline to week 16
    Ad 13: from baseline to week 16
    Ad 14: from baseline to week 16
    Ad 15: from baseline to week 16
    Ad 16: from baseline to week 16
    Ad 17: from baseline to week 16
    Ad 18: through week 16
    Ad 19: through week 16
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Czech Republic
    Germany
    Poland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 Last Subject
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 330
    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: 330
    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 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 state93
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 330
    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 patients may have a chance to participate in Open-Label Extension
    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 Decision2018-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-09
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