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    Summary
    EudraCT Number:2014-004341-27
    Sponsor's Protocol Code Number:MK-3641-008
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-01
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2014-004341-27
    A.3Full title of the trial
    A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ragweed Efficacy and Safety Pediatric Trial
    A.3.2Name or abbreviated title of the trial where available
    Ragweed Efficacy and Safety Pediatric Trial
    A.4.1Sponsor's protocol code numberMK-3641-008
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/266/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck, Sharp & Dohme d.o.o.
    B.5.2Functional name of contact pointGlobal Clinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street AddressIvana Lucica 2a
    B.5.3.2Town/ cityZagreb
    B.5.3.3Post code10000
    B.5.3.4CountryCroatia
    B.5.4Telephone number+385166 11 333
    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 RAGWITEK®
    D.2.1.1.2Name of the Marketing Authorisation holderALK-Abelló A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameShort Ragweed Pollen Allergenic Extract
    D.3.2Product code MK-3641
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmbrosia artemisiifolia
    D.3.9.2Current sponsor codeMK-3641
    D.3.9.3Other descriptive nameAMBROSIA ARTEMISIIFOLIA
    D.3.9.4EV Substance CodeSUB127622
    D.3.10 Strength
    D.3.10.1Concentration unit AgU antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 Yes
    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 placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rhinoconjunctivitis due to ragweed allergy
    E.1.1.1Medical condition in easily understood language
    Ragweed allergic rhinitis
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of MK-3641 sublingual immunotherapy tablet (12 Amb a 1-U) versus placebo in the treatment of children 5 to 17 years of age with ragweed-induced rhinoconjunctivitis, with or without asthma, based on the Total Combined Score (TCS) [sum of rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS)] averaged over the peak ragweed season (RS)
    E.2.2Secondary objectives of the trial
    To compare the following between the MK-3641 (12 Amb a 1 U) and placebo groups:
    1.Average TCS during the entire RS ;
    2.Average rhinoconjunctivitis DSS during the peak RS;
    3.Average rhinoconjunctivitis DMS during the peak RS.

    To assess the overall safety of MK-3641 (12 Amb a 1 U) in children 5 to 17 years of age with ragweed-induced rhinoconjunctivitis, with or without asthma.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood and/or saliva) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    In order to be eligible for participation in this trial, the subject must:
    1.Have a legal representative who provides written informed consent for the trial on the subject’s behalf. The legal representative may also provide consent for Future Biomedical Research on the subject’s behalf. The subject, depending on their age and ability to understand the nature and intent of the study, must also assent to participate in the study main trial and to Future Biomedical Research.
    2.Be ≥4 to ≤17 years of age on the day informed consent is obtained, however, the subject must be ≥5 years old at the Randomization Visit. The subject may be of either gender and any race/ethnicity.
    3.Have a clinical history of significant ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis of ≥1 year (at least 1 season for ages 4 to 6 years) or ≥2 years (at least 2 seasons for ages 7 to 17 years) duration diagnosed by a physician (with or without asthma) and have received treatment for the condition during the
    previous ragweed season.
    4.Have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit.
    5.Have a specific IgE against Ambrosia artemisiifolia ≥ IgE Class 2 (0.7 kU/L) at the Screening Visit.
    6.Have a forced expiratory volume in 1 second (FEV1) ≥80% of predicted value at the Screening and Randomization Visits.
    Note: A subject who is ≤7 years old and cannot perform reproducible FEV1 maneuvers, despite coaching, does not need to meet this criterion.
    7.Be able to read, understand, and complete the questionnaires and diaries (or can have help from the parent/guardian).
    8.If female, agree to remain abstinent or use (or have their partner use) an acceptable method of birth control.

    Refer to protocol for complete list of inclusion criteria.
    E.4Principal exclusion criteria
    The subject must be excluded from participating in the trial if the subject:
    1.Has a clinical history of symptomatic seasonal allergic rhinitis (and/or asthma) due to another allergen, which has required regular medication during, or potentially overlapping, the ragweed season.
    2.Has a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the subject is regularly exposed during the ragweed season which would interfere with assessment of the treatment effect.
    3.Has any nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis).
    4.Has asthma requiring high daily doses of inhaled corticosteroids within the 6 months prior to the Screening Visit.
    5.Is one of the following:
    • >7 years old and cannot perform reproducible FEV1 maneuvers despite coaching;
    • ≤7 years old who cannot perform reproducible FEV1 maneuvers despite coaching and has current symptoms of asthma characterized by recurrent episodes of wheezing, or episodes of cough, wheeze, difficulty in breathing, or chest tightness.
    6.Has severe, unstable, or uncontrolled asthma, as judged by the clinical investigator, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta-agonists) at any time within the last 3 months prior to the Screening or Randomization Visits.
    7.Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen.
    8.Has a diagnosis of eosinophilic esophagitis.
    9.Has a history of chronic urticaria and/or chronic angioedema.
    10.Has a clinical history of chronic sinusitis during the 2 years prior to the Screening or Randomization Visits.
    11.Has current severe atopic dermatitis.
    12.Has a history of allergy, hypersensitivity, or intolerance to the ingredients of the investigational medicinal products (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine.
    13.Has previously received MK-3641.
    14.Is unable to meet medication washout requirements.

    Refer to protocol for complete list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study, the Total Combined Score (TCS), is a combination of (sum of) the rhinoconjunctivitis daily symptom score (DSS) and the rhinoconjunctivitis daily medication score (DMS) averaged over the peak ragweed season.
    E.5.1.1Timepoint(s) of evaluation of this end point
    peak ragweed season
    E.5.2Secondary end point(s)
    •Average Total Combined Score (TCS) during the Entire Ragweed Season (RS)
    •Average rhinoconjunctivitis Daily Symptom Score (DSS) during the Peak Ragweed Season
    •Average rhinoconjunctivitis Daily Medication Score (DMS) during the Peak Ragweed Season
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Entire Ragweed Season
    •Peak Ragweed Season
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Russian Federation
    Serbia
    Ukraine
    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.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 1000
    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: 350
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 650
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-02-01. Yes
    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
    Pediatric subjects
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state79
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 1000
    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)
    Once a subject has ended participation in the study, he/she will revert to usual care according to his/her own personal 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 Decision2015-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-19
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