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    The EU Clinical Trials Register currently displays   37995   clinical trials with a EudraCT protocol, of which   6234   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2016-000955-28
    Sponsor's Protocol Code Number:R668-AD-1539
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-10
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2016-000955-28
    A.3Full title of the trial
    A phase 2/3 study investigating the pharmacokinetics, safety, and efficacy of Dupilumab in patients aged ≥6 months to <6 years 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
    Safety, pharmacokinetics and efficacy of Dupilumab in patients ≥6 months to <6 years with severe atopic dermatitis
    A.3.2Name or abbreviated title of the trial where available
    Liberty AD PRESCHOOL
    A.4.1Sponsor's protocol code numberR668-AD-1539
    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
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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 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
    Investigating the pharmacokinetics, safety and efficacy of dupilumab in patients aged ≥6 months to <6 years with severe atopic dermatitis. Part A of the study is to characterise safety and pharmacokinetics of a single dose of dupilumab. Part B is to demonstrate efficacy from multiple doses of dupilumab.
    E.2.2Secondary objectives of the trial
    Investigating the safety, efficacy and immunogenicity of dupilumab for patients aged ≥6 months to <6 years with severe atopic dermatitis. Secondary objective of Part A of the study is to investigate efficacy and immunogenicity of a single dose of dupilumab. Secondary objective of Part B is to assess the safety and immunogenicity of multiple doses of dupilumab over 16 weeks.
    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
    2. Vaccine sub-study (for Part B only)
    E.3Principal inclusion criteria
    1. Diagnosis of AD according to the American Academy of Dermatology consensus criteria at the screening visit
    2. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s)
    3. IGA = 4 at screening and baseline visits
    4. EASI ≥21 at screening and baseline visits
    5. Body Surface Area (BSA) ≥15% at screening and baseline visits
    E.4Principal exclusion criteria
    1. Participation in a prior dupilumab clinical study
    2. History of important side effects of medium potency topical corticosteroids (only applicable for part B of the study)
    3. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
    4. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
    5. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
    6. 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
    7. History of malignancy at any time before the baseline visit.
    8. Diagnosed active endoparasitic infections or at high risk of these infections
    9. 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)
    Part A:
    1. Concentration of total dupilumab in serum over time and PK parameters
    2. The incidence and severity of treatment-emergent adverse events (TEAEs) through the end of part A.

    Part B:
    1. The proportion of patients with an IGA score of 0 to 1
    2. For European Medicines Agency - EMA only: Proportion of patients with Eczema Area and Severity Index (EASI) -75 (≥75% improvement from baseline)
    3. For EMA only: Proportion of patients with an IGA score of either 0 or 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A:
    Ad 1: To week 4
    Ad 2: To week 4

    Part B:
    Ad 1: Week 16
    Ad 2: From baseline to week 16
    Ad 3: Week 16
    E.5.2Secondary end point(s)
    Part A:
    1. The incidence of serious adverse events (SAEs) and severe TEAEs
    2. Percent change in EASI score from baseline to week 4
    3. Percent change in SCORing Atopic Dermatitis (SCORAD)
    4. Proportion of patients with an IGA score of either 0 or 1
    5. Determine immunogenicity titer

    Part B:
    1. Not applicable for EMA: Proportion of patients with EASI-75 (≥75% improvement from baseline)
    2. Percent change in EASI score
    3. Reduction in pruritus (appropriate measure and endpoint definition in this patient population to be determined)
    4. Proportion of patients with EASI-50
    5. Proportion of patients with EASI-90
    6. Change in percent Body Surface Area (BSA) affected by AD
    7. Percent change in SCORAD
    8. Change Childrens’ Dermatology Life Quality Index (CDLQI) for patients ≥4 years of age
    9. Change in Infants’ Dermatology Quality of Life Index (IDQOL) for patients <4 years of age
    10. Change in Dermatitis Family Index (DFI)
    11. Change in Patient Oriented Eczema Measure (POEM)
    12. Topical treatment for AD – proportion of medication-free days
    13. Mean weekly dose of Topical corticosteroids
    14. Mean of caregiver missed workdays
    15. Incidence of skin infection TEAEs
    16. Incidence of SAEs through week 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A:
    Ad 1: Baseline to week 4
    Ad 2: Baseline to week 4
    Ad 3: Baseline to week 4
    Ad 4: At week 4
    Ad 5: To week 4

    Part B:
    Ad 1: At week 16
    Ad 2: From baseline to week 16
    Ad 3: At week 16
    Ad 4: At week 16
    Ad 5: At 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: To week 16
    Ad 14: From baseline to week 16
    Ad 15: To week 16
    Ad 16: 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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Vaccine response
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Controlled, Randomised, Double-blind, Parallel group - Yes (only for part B of the study)
    Single ascending-dose, Sequential cohort study staggered by age
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Czech Republic
    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 of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 280
    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) Yes
    F. of subjects for this age range: 100
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 180
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 280
    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 Decision2018-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
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