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    Summary
    EudraCT Number:2015-004458-16
    Sponsor's Protocol Code Number:R668-AD-1526
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-10-28
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-004458-16
    A.3Full title of the trial
    Randomized, Double-blind, Placebo-controlled Study to Investigate the
    Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of
    Age, With Moderate-to-severe Atopic Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Dupilumab in Patients ≥12 to <18 Years of Age, With
    Moderate-to-Severe Atopic Dermatitis
    A.4.1Sponsor's protocol code numberR668-AD-1526
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03054428
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/169/2014
    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 Rd.
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    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 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 REGN668/SAR231893
    D.3.4Pharmaceutical form Solution for injection
    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 codeREGN668/SAR231893
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatits
    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 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
    The primary objective of the study is to demonstrate the efficacy of dupilumab as a monotherapy in patients ≥12 years to <18 years of age with moderate-to-severe AD.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the safety of dupilumab as a monotherapy in patients ≥12 years to <18 years of age with moderate-to-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
    The purpose of the genomic analyses is to identify genomic associations with clinical or biomarker response, other clinical outcome measures and possible AEs.
    E.3Principal inclusion criteria
    • Male or female ≥12 to <18 years of age at time of screening visit
    • Diagnosis of AD according to the American Academy of Dermatology
    consensus criteria at screening visit
    • IGA ≥3 at screening and baseline visit
    • EASI ≥16 at the screening and baseline visit
    • Baseline Pruritus NRS average score for maximum itch intensity ≥4
    • ≥10% BSA of AD involvement at the screening and baseline visits
    • With documented recent history (within 6 months before the screening
    visit) of inadequate response to topical AD medication(s) or for whom
    topical treatments is medically inadvisable
    E.4Principal exclusion criteria
    • Participation in a prior dupilumab clinical study
    • Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors
    (TCI) within 2 weeks before the baseline visit
    • Having used immunosuppressive/immunomodulating drugs within 4 weeks
    before the baseline visit
    • Body weight <30 kg at baseline
    • Active chronic or acute infection requiring treatment with systemic
    antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before
    the baseline visit
    • Known or suspected immunodeficiency, known history of human
    immunodeficiency virus (HIV) infection or HIV seropositivity at the
    screening visit, established diagnosis of HBV infection or HBV
    seropositivity at screening, established diagnosis of HCV infection or HCV
    seropositivity at screening
    • History of malignancy before the baseline visit
    • Diagnosed active endoparasitic infections or at high risk of these infections
    • Patient is female who is pregnant, breastfeeding, or planning to become
    pregnant or breastfeed during the study
    • Patient is female of childbearing potential and sexually active, who is
    unwilling to use adequate methods of contraception throughout the
    duration of the study and for 120 days after the last dose of study drug
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with Investigator Global Assessment (IGA) 0 to 1 (on a 5-point scale)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    E.5.2Secondary end point(s)
    - Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline)
    - Percent change in EASI score
    - Percent change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS)
    - Proportion of participants with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥3
    - Proportion of participants with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥4
    - Proportion of patients with EASI-50 (≥50% improvement from baseline)
    - Proportion of patients with EASI-90 (≥90% improvement from baseline)
    - Time to onset of effect on pruritus during the 16-week treatment period (≥3 point reduction of weekly average of peak Pruritus NRS from baseline
    - Time to onset of effect on pruritus during the 16-week treatment period (≥4 point reduction of weekly average of peak Pruritus NRS from baseline
    - Change in percent body surface area (BSA) affected by AD
    - Percent change in SCORing Atopic Dermatitis (SCORAD)
    - Change in Children's Dermatology Life Quality Index (CDLQI)
    - Change in Patient Oriented Eczema Measure (POEM)
    - Change in weekly average of daily peak Pruritus NRS
    - Percent change in weekly average of daily peak Pruritus NRS
    - Change in Hospital Anxiety and Depression Scale (HADS)
    - Proportion of participants with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥4
    - Incidence of skin-infection treatment-emergent adverse events (TEAEs) (excluding herpetic infections)
    - Incidence of serious TEAEs
    [Time Frame: Baseline to week 16]
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to 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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 240
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 240
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatric subjects
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 240
    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)
    Standard therapy
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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