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    Summary
    EudraCT Number:2012-005227-33
    Sponsor's Protocol Code Number:PILIT_2013
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-005227-33
    A.3Full title of the trial
    Effect of Intralymphatic Immunotherapy on Basophil Response and Plasma Cell Kinetics in Allergic Patients
    Effekt af intralymfatisk immunterapi på basophil response og plasma celle kinetik hos allergiske patienter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of allergy vaccination given as injections into lymph nodes on the immune system of allergic patients
    Effekten af allergivaccination der gives som indsprøjtning i lymfeknuder på immunsystemet af patienter med allergi
    A.3.2Name or abbreviated title of the trial where available
    PILIT
    A.4.1Sponsor's protocol code numberPILIT_2013
    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 SponsorDepartment of Respiratory Diseases, Aarhus University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegion Midtjylland
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Respiratory Diseases
    B.5.2Functional name of contact pointPILIT
    B.5.3 Address:
    B.5.3.1Street AddressNoerrebrogade 44
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004578462106
    B.5.6E-mailhans.jurgen.hoffmann@ki.au.dk
    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 Alutard SQ phleum pratense (ALK 225)
    D.2.1.1.2Name of the Marketing Authorisation holderALK-abelló
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameALK 225, Alutard SQ phleum pratense
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgrass pollen extract
    D.3.9.3Other descriptive name12 GRASS POLLEN MIXTURE
    D.3.9.4EV Substance CodeSUB49501
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    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 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 placeboInjection
    D.8.4Route of administration of the placeboIntralymphatic use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntralymphatic use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    allergic rhino-conjunctivitis
    allergisk høfeber
    E.1.1.1Medical condition in easily understood language
    hayfever
    høfeber
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10039085
    E.1.2Term Rhinitis allergic
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10010744
    E.1.2Term Conjunctivitis allergic
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We would like to evaluate the effect of Intralymphatic Immunotherpy (ILIT) on patients with rhinoconjunctivitis due to grass pollen allergy.
    1. Is the clinical effect comparable to that of Subcutaneous Immunotherapy (SCIT) measured in BasoSCIT (funded by Lundbeck grant R32-A1482)
    2. Does a booster injection after one year confer additional symptom relief
    3. Can enumerating plasma cells one week after injection monitor ILIT?
    4. Is the effect on Basophil activation (BAT EC50) a useful tool to document clinical effect?
    E.2.2Secondary objectives of the trial
    Establish a new method of immunotherapy, intralymphatic immunotherapy at the Allergy Center, Dept. of Respiratory Diseases, Aarhus University Hospital
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    We have planned to do a pilot-study, before starting the main study, to establish the technical procedures needed in the main study: intralymphatic injections, flow-cytometric cell investigation
    E.3Principal inclusion criteria
    history of seasonal rhino-conjunctivitis during the grass pollen season
    positive skin prick test for grass pollen extract
    informed consent given
    E.4Principal exclusion criteria
    severe comorbidity
    uncontrolled asthma bronchiale
    pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    - a significant decrease in allergic symptoms during grass pollen season
    -a decrease in basophil sensitivity measured by basophil activation test (10 fold)
    -detection of specific plasma cells one week after injections
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. during the grass pollen seasons in 2014 and 2015
    2. 3 weeks after injections
    3. 1 week after injections
    E.5.2Secondary end point(s)
    -a possible positive effect of a booster injection after one year
    -changes in specific immunoglobulins (IgE, IgX)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. season 2015
    2. measurements performed througout the whole study, 2013-2015
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 42
    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 state42
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 42
    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 Decision2013-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-01
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