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    Summary
    EudraCT Number:2019-004523-21
    Sponsor's Protocol Code Number:V1605-201
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-09
    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
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2019-004523-21
    A.3Full title of the trial
    A Phase 2 Study to Evaluate the Sensitivity and Specificity of DBV1605, a Ready to Use Atopy Patch Test for the Diagnosis of Non-Immunoglobulin E Mediated Cow’s Milk Allergy in Children.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess DBV1605 for the diagnosis of cow's milk allergy in children.
    A.3.2Name or abbreviated title of the trial where available
    APTITUDE
    A.4.1Sponsor's protocol code numberV1605-201
    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 SponsorDBV Technologies S.A.
    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 supportDBV Technologies SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDBV Technologies S.A.
    B.5.2Functional name of contact pointDBV Technologies S.A.
    B.5.3 Address:
    B.5.3.1Street Address177-181 avenue Pierre Brossolette
    B.5.3.2Town/ cityMontrouge
    B.5.3.3Post code92120
    B.5.3.4CountryFrance
    B.5.6E-mailaptitude.study@dbv-technologies.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.3.2Product code DBV1605 active and control patch
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMilk allergen extract
    D.3.9.3Other descriptive nameCOW MILK EXTRACT
    D.3.9.4EV Substance CodeSUB84552
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number144 to 216
    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 Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Immunoglobulin E Mediated Cow’s Milk Allergy
    E.1.1.1Medical condition in easily understood language
    Cow’s Milk Allergy
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011240
    E.1.2Term Cow's milk allergy
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the diagnostic performance of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow’s milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA based on the sensitivity and the
    specificity.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to:
    • Estimate the specificity of DBV1605 in a control group of subjects;
    • Assess the diagnostic performance of DBV1605 in different subgroups of interest;
    • Assess the adhesion and application duration of the DBV1605 patch;
    • Assess the safety of a single 48-hour application of DBV1605.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    DISEASE GROUP
    • Male or female subjects aged 1 month to 5 years at Screening Visit,
    • Subjects with a history of symptoms that are consistent with non-IgE mediated CMA as per Investigator’s assessment, by either:
    o Two or more gastrointestinal symptoms (vomiting, diarrhea, persistent distress/colic, regurgitation, constipation), that lasted at least 1 week within 1
    month prior to Screening Visit
    o Blood in stool,
    • Subjects with any type of diet containing regular cow’s milk protein (e.g. cow’s milk consumption, cow’s milk partial elimination, partially hydrolyzed milk) within 1 month prior to Screening Visit,
    • Subjects with a negative cow’s milk SPT: mean wheal diameter <3 mm and negative control <1 mm.
    Subjects may be included in the disease group if they do not meet, among other criteria, any of the following exclusion criteria:
    • Subjects with an established diagnosis of non-IgE mediated CMA made by a physician after appropriate diagnostic testing including cow’s milk protein challenge,
    • Breast-fed subject at Screening Visit,
    • Subjects with a history of confirmed food protein-induced enterocolitis syndrome,
    • Subjects with a convincing history of IgE-mediated CMA.
    CONTROL GROUP
    Subjects may be included in the control group only if they meet, among other criteria, the following inclusion criteria:
    • Male or female subjects aged 1 month to 5 years at Visit 1,
    • Subjects having no medical history of any type of allergy, including no history of IgE-mediated allergic reactions to cow’s milk and with no medical history of any food allergy in their family (parents, sibling),
    • Subjects who tolerate at least 200 mL of cow’s milk or equivalent dairy foods daily within 1 month prior to Visit 1.
    • Subjects with negative cow’s milk SPT: mean wheal diameter <3 mm and negative control <1 mm.
    Subjects may be included in the control group if they do not meet, among other criteria, any of the following exclusion criteria:
    • Subjects with history of persistent gastro-intestinal symptoms including vomiting, diarrhea, distress/colic, regurgitation, constipation, blood in stool, for at least 4 consecutive weeks within the previous year.
    • Breast-fed subjects at Visit 1.
    E.4Principal exclusion criteria
    (The full list of the disease group and the Control group's exclusion criteria is within the study protocol)

    DISEASE GROUP
    1 Subjects with an established diagnosis of non-IgE mediated CMA made by a physician after appropriate diagnostic testing including cow’s milk protein challenge.
    2 Breast-fed subjects at Screening Visit.
    3 Subjects on a cow’s milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula within 1 month of Screening Visit.
    4 Subjects with a history of confirmed FPIES.
    5 Any contraindication to a cow’s milk challenge, in particular subjects with a history of severe anaphylactic reaction to cow’s milk. Severe anaphylaxis is defined as Grade 3 of the Anaphylaxis Staging System, including:
    • Severe hypoxia, persistent hypotension or more than 20% drop in blood pressure, neurological compromise, or
    • Cyanosis or SpO2 ≤ 92% at any stage, confusion, cardiovascular collapse, loss of consciousness, bradycardia, cardiac arrest.
    6 Subjects with a convincing history of IgE-mediated CMA.
    10 Known hypersensitivity to any of the DBV1605 components (except to milk proteins).
    11 Known hypersensitivity to any component of the food challenge formula (except to milk proteins).
    12 A history of any immunotherapy for CMA.
    15 Any disorder in which epinephrine is contraindicated such as congenital cardiac malformation, uncontrolled hypertension, or serious ventricular arrhythmias.
    17 Intake of leukotriene receptor antagonists or 5-lipooxygenase inhibitors within 30 days prior to Screening Visit.
    18 Treatment with antihistamines within 1 to 7 days (depending on half-life and specified in APPENDIX 3) prior to Screening Visit or inability to discontinue antihistamines for the minimum wash-out periods required prior to SPT or food challenges.
    19 Treatment with topical steroid applied on the back within 30 days prior to Screening Visit.
    E.5 End points
    E.5.1Primary end point(s)
    The sensitivity and the specificity of DBV1605 based on skin reactivity readings after 48 hours and 72 hours will be compared to the results of the DBPCFC in subjects of the disease group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The DBV1605 patch test will be considered positive if, after 48 hours and/or 72 hours following application:
    • The skin reactivity under the control patch is rated Grades 0 or 1, and
    • The skin reactivity under the active patch is rated at least 1 grade higher than the control patch.
    The DBV1605 patch test will be considered negative if after both 48 hours and 72 hours:
    • The skin reactivity under the control patch is rated Grades 0 or 1, and
    • The skin reactivity under the active patch is rated the same grade as the control patch or 1 grade lower than the control patch.
    E.5.2Secondary end point(s)
    In the disease group of subjects:
    • DBV1605 sensitivity and specificity after readings at 48 hours;
    • DBV1605 sensitivity and specificity after readings at 72 hours;
    • DBV1605 sensitivity and specificity considering the test positive if, after 48 hours and/or 72 hours following application:
    o The skin reactivity under the control patch is rated Grades 0 or 1, and
    o The skin reactivity under the active patch is rated at least 2 grades higher than the control patch.
    In addition, other indicators of DBV1605 diagnostic performance could be explored, and subgroups could be considered for the analysis. The following secondary analyses will be conducted in the control group to confirm the results observed in the disease group:
    • DBV1605 specificity after readings at 48 hours and 72 hours in the control group.
    The adhesion of DBV1605 will be assessed with:
    • The proportions of patches with adhesion scored Grade 0 or 1 and the proportions of patches with adhesion scored higher than 1 at application;
    • The proportions of patches with adhesion scored Grade 0 or 1 and the proportions of patches with adhesion scored higher than 1 at removal.
    The duration of DBV1605 application will be assessed with:
    • The proportions of patches without detachment of the occlusive chamber as assessed by the parents/guardians at different timepoints: 24 hours ±1 hour, 36 hours ±1 hour and 48 hours ±1 hour;
    • The proportions of patches present at the application site more than 36 hours after application, excluding voluntary removal;
    • The mean duration of patch application until removal or detachment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    DBV1605 sensitivity and specificity readings at after 48 hours and 72 hours. The test will be considered positive if, after 48 hours and/or
    72 hours following application:
    o The skin reactivity under the control patch is rated Grades 0 or 1, and
    o The skin reactivity under the active patch is rated at least 2 grades higher than the control patch.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    active and control patch of the same IMP
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Italy
    Lithuania
    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 years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days28
    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: 230
    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: 180
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    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 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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 230
    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)
    Subjects will receive medical standard of care according to the judgment of the treating physician.
    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 Decision2020-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-27
    P. End of Trial
    P.End of Trial StatusOngoing
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