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    Summary
    EudraCT Number:2013-001754-10
    Sponsor's Protocol Code Number:OLFUS-VIPES
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-07
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-001754-10
    A.3Full title of the trial
    Open-label follow-up study of the VIPES study to evaluate long-term efficacy and safety of the Viaskin Peanut
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Follow-up study to evaluate long-term efficacy and safety of Viaskin Peanut patch in desensitization to peanut
    A.3.2Name or abbreviated title of the trial where available
    OLFUS-VIPES
    A.4.1Sponsor's protocol code numberOLFUS-VIPES
    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 S.A
    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 pointClinical trials officer
    B.5.3 Address:
    B.5.3.1Street AddressGreen Square - Bâtiment D - 80/84 rue des Meuniers
    B.5.3.2Town/ cityBagneux
    B.5.3.3Post code92220
    B.5.3.4CountryFrance
    B.5.4Telephone number0033155427874
    B.5.5Fax number0033972364971
    B.5.6E-mailclindev@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.3.1Product nameViaskin Peanut
    D.3.2Product code DBV712
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    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 INNpeanut allergen extract
    D.3.9.3Other descriptive namepeanut allergen extract
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number64.5 to 99.8
    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 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
    Treatment of peanut allergy in adults and children age 7 years and older with documented hypersensitivity to peanut. The induction of clinical desensitization to peanut in patients allergic to peanut should reduce the risk of anaphylaxis in case of accidental exposure to small amounts of peanut proteins.
    E.1.1.1Medical condition in easily understood language
    Peanut allergy
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10034202
    E.1.2Term Peanut 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 efficacy of Viaskin Peanut after up to 36 months of Epicutaneous Immunotherapy (EPIT) in peanut-allergic subjects.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of long-term treatments with Viaskin Peanut.
    To evaluate the sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after EPIT with Viaskin Peanut.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult and pediatric subjects (≥7 years) who completed the VIPES study, with a mandatory and documented Double-Blind Placebo-Controlled Food Challenge (DBPCFC) at Month 12 in the VIPES study.
    E.4Principal exclusion criteria
    1. Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for more than two doses of epinephrine.
    2. Pregnancy or lactation.
    3. Females of childbearing potential planning a pregnancy in the coming 2 to 3 years.
    4. Subjects who became allergic to chocolate or who do not want to consume the chocolate study challenge vehicle anymore.
    5. Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the food challenge formula used during the VIPES study.
    6. Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to skin prick testing or food challenges.
    7. Subjects with asthma that has evolved and now fulfills any of the criteria defined as follows:
    a. uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled β2-agonists.
    b. at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months.
    c. prior intubation for asthma in the past year.
    8. Subjects receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
    9. Subjects receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy.
    10. Subjects receiving or planning to receive any type of immunotherapy to any food (e.g. oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) during their participation in the study.
    11. Subjects receiving or planning to receive any aeroallergen immunotherapy during their participation in the study.
    12. Allergy or know history of reaction to Tegaderm® with no possibilities to use an alternative dressing approved by the sponsor.
    13. Subjects suffering from generalized dermatologic disease (e.g. severe atopic dermatitis, uncontrolled generalized eczema, ichthyosis vulgaris) with no intact zones to apply the Viaskin® patches.
    14. Subjects or parent(s)/guardian(s) of subjects with obvious excessive anxiety and unlikely to cope with the conditions of a food challenge.
    15. Past or current disease(s) which, in the opinion of the Investigator or the Sponsor, may affect the subject’s participation in this study, including but not limited to active eosinophilic gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (e.g. hypertension, psychiatric, cardiac), or other disorders (e.g. liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders).
    16. Any new disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.
    17. A history of drug or alcohol abuse while in the VIPES study.
    18. A history of non compliance in the VIPES study. Non compliance is defined as subjects not applying the patch at all for 60 days or more (this can be either consecutive or intermittent non application of the patches) during the whole VIPES study duration.
    19. Subjects unable to follow the protocol requirements.
    20. Participation in another clinical intervention study in the past year, other than the VIPES study.
    21. Subjects on any experimental drugs in the past year, other than those used in the VIPES study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints:
    1/ Proportion of subjects with a peanut protein eliciting dose equal to or greater than 1000 mg peanut or with a ≥10-fold increase of the eliciting dose compared to their baseline eliciting dose observed in the VIPES study.
    2/ The proportion of subjects unresponsive (i.e. showing no objective symptoms during DBPCFC) to a cumulative dose of 1440 mg peanut protein or above.
    3/ The proportion of subjects with a sustained unresponsiveness (i.e. showing no objective symptoms during DBPCFC after a period of 2 months without treatment) to a cumulative dose of 1440 mg peanut protein or above at Month 26.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1/ Month 12 and month 24
    2/ Month 12 and month 24
    3/ Month 26
    E.5.2Secondary end point(s)
    Safety endpoints:
    Adverse events (AEs) by system organ class, severity and relatedness to Viaskin® Peanut (all subjects and by age strata).
    Serious AEs (SAEs) by system organ class, severity and relatedness to Viaskin® Peanut (all subjects and by age strata).
    Systemic allergic symptoms and relatedness to Viaskin® Peanut (all subjects and by age strata).
    Severity of AEs or SAEs elicited during the study and the DBPCFCs (all subjects).
    Laboratory data, physical examinations and vital signs (all subjects).
    Spirometry results (all subjects).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Initial visit and 6, 12, 18, 24, 26 months
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    France
    Netherlands
    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 the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 180
    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: 110
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 70
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 220
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
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