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    Summary
    EudraCT Number:2019-003078-24
    Sponsor's Protocol Code Number:R668-EE-1877
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-01
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-003078-24
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (EoE KIDS)
    A.4.1Sponsor's protocol code numberR668-EE-1877
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04394351
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/059/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegeneron Pharmaceuticals
    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
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals
    B.5.2Functional name of contact pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Rd.
    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 holdersanofi-aventis groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 codeREGN668
    D.3.9.4EV Substance CodeSUB130625
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Eosinophilic Esophagitis
    E.1.1.1Medical condition in easily understood language
    A chronic allergic/immune condition characterized by inflammation of
    the esophagus
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10064212
    E.1.2Term Eosinophilic oesophagitis
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    •To demonstrate efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS)
    •To evaluate safety, tolerability, & immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE
    •To evaluate effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation
    •To study effects of dupilumab on the type 2 inflammation gene expression signature
    •To evaluate concentration-time profile of functional dupilumab in serum
    •To assess efficacy of long-term (52 weeks) dupilumab treatment
    •To assess safety, tolerability, and immunogenicity of long-term dupilumab treatment
    •To evaluate impact of dupilumab treatment on EoE signs & symptoms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    •A documented diagnosis of eosinophilic esophagitis (EoE)
    •Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration (peak eosinophil count ≥15
    eos/hpf; [400 x])
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    •Body weight <5 kg or ≥60 kg at screening
    •Other causes of esophageal eosinophilia
    •Active Helicobacter pylori
    •History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
    •Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
    •Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
    •History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopy procedure
    •Active parasitic infection or suspected parasitic infection
    •Known or suspected immunodeficiency disorder

    NOTE: Other protocol defined inclusion/exclusion criteria apply
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving peak esophageal intraepithelial eosinophil count ≤6 eos/hpf (400×)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    E.5.2Secondary end point(s)
    1.Proportion of patients achieving peak esophageal intraepithelial eosinophil count ≤6 eos/hpf (400×) [ Time Frame: At week 52 ]
    2.Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf [ Time Frame: At week 16 ]
    3.Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf [ Time Frame: At week 52 ]
    4.Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf) [ Time Frame: At week 16 ]
    5.Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf) [ Time Frame: At week 52 ]
    6.Absolute change in mean eosinophilic esophagitis (EoE) Histology Scoring System (EoE-HSS) [ Time Frame: At week 16 ]
    7.Absolute change in mean eosinophilic esophagitis (EoE) Histology Scoring System (EoE-HSS) [ Time Frame: At week 52 ]
    8.Absolute change in Eosinophilic Esophagitis-Endoscopic Reference (EoE EREFS) [ Time Frame: At week 16 ]
    9.Absolute change in Eosinophilic Esophagitis-Endoscopic Reference (EoE EREFS) [ Time Frame: At week 52 ]
    10.Change in the type 2 inflammation transcriptional signature [ Time Frame: At week 16 ]
    11.Change in the type 2 inflammation transcriptional signature [ Time Frame: At week 52 ]
    12.Change in the proportion of days with 1 or more EoE signs as measured by the Pediatric EoE Sign/Symptom Questionnaire- caregiver version (PESQ-C) [ Time Frame: At week 16 ] For patients aged ≥1 to <12 years
    13.Change in the proportion of days with 1 or more EoE signs as measured by the PESQ-C [ Time Frame: At week 52 ] For patients aged ≥1 to <12 years
    14.Change in the proportion of total segments within a day with 1 or more EoE signs as measured by PESQ-C [ Time Frame: At week 16 ] For patients aged ≥1 to <12 years
    15.Change in the proportion of total segments within a day with 1 or more EoE signs as measured by PESQ-C [ Time Frame: At week 52 ] For patients aged ≥1 to <12 years
    16.Change in the proportion of days with 1 or more EoE symptoms as measured by the Pediatric EoE Sign/Symptom Questionnaire-patient version (PESQ-P) [ Time Frame: At week 16 ] For patients aged ≥8 to <12 years
    17.Change in the proportion of days with 1 or more EoE symptoms as measured by PESQ-P [ Time Frame: At week 52 ] For patients aged ≥8 to <12 years
    18.Change in the proportion of total segments within a day with 1 or more EoE symptoms as measured by PESQ-P [ Time Frame: At week 16 ] For patients aged ≥8 to <12 years
    19.Change in the proportion of total segments within a day with 1 or more EoE symptoms as measured by PESQ-P [ Time Frame: At week 52 ] For patients aged ≥8 to <12 years
    20.Change in total score as measured by the PEESSv2.0-caregiver version questionnaire [ Time Frame: At week 16 ] For patients aged ≥1 to <12 years
    21.Normalized Enrichment Scores (NES) for the relative change in the EoE diagnostic panel (EDP) transcriptome signature [ Time Frame: At week 16 ]
    22.NES for the relative change in the EDP transcriptome signature [ Time Frame: At week 52 ]
    23.NES for the relative change in the type 2 inflammation transcriptome signature [ Time Frame: At week 16 ]
    24.NES for the relative change in the type 2 inflammation transcriptome signature [ Time Frame: At week 52 ]
    25.Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: At week 16 ]
    26.Incidence of TEAEs [ Time Frame: At week 52 ]
    27.Incidence of treatment-emergent serious adverse events (SAEs) [ Time Frame: At week 16 ]
    28.Incidence of treatment-emergent SAEs [ Time Frame: At week 52 ]
    29.Incidence of treatment-emergent adverse events of special interest (AESIs) [ Time Frame: At week 16 ]
    30.Incidence of treatment-emergent AESIs [ Time Frame: At week 52 ]
    31.Incidence of TEAEs leading to permanent discontinuation of study treatment [ Time Frame: At week 16 ]
    32.Incidence of TEAEs leading to permanent discontinuation of study treatment [ Time Frame: At week 52 ]
    33.Incidence of treatment-emergent Anti-drug antibody (ADA) responses and titer [ Time Frame: At week 16 ]
    34.Incidence of treatment-emergent ADA responses and titer [ Time Frame: At week 52 ]
    35.Concentration of functional dupilumab in serum [ Time Frame: Up to week 52 ]
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 52; At week 16; Up to week 52
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 years3
    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: 60
    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.1.1.4.1Number of subjects for this age range: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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