Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43233   clinical trials with a EudraCT protocol, of which   7153   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-000984-15
    Sponsor's Protocol Code Number:PQBirch204
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-04
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-000984-15
    A.3Full title of the trial
    A multi-centre, double-blind, placebo-controlled study to explore the safety and efficacy of Birch Modified Allergen Tyrosine adsorbed + MPL (POLLINEX® Quattro Plus 1.0 mL Birch [PQ Birch]) in subjects with seasonal allergic rhinoconjunctivitis due to birch pollen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this phase II placebo controlled study is to assess the safety and efficacy on conjunctival provocation test (CPT) of different short courses of PQ Birch treatment, as part of the clinical development programme of this product.
    A.4.1Sponsor's protocol code numberPQBirch204
    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 SponsorAllergy Therapeutics (UK) Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportAllergy Therapeutics (UK) Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBencard Allergie GmbH
    B.5.2Functional name of contact pointClinical Research Management
    B.5.3 Address:
    B.5.3.1Street AddressMesserschmittstraße 4
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80992
    B.5.3.4CountryGermany
    B.5.4Telephone number+490893681198
    B.5.5Fax number+490893681197
    B.5.6E-maildenise.lee@allergytherapeutics.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 namePollinex Quattro Birch (300 SU/mL)
    D.3.4Pharmaceutical form Suspension for injection
    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.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU Standardised Unit(s) (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.IMP: 2
    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 namePollinex Quattro Birch (800 SU/mL)
    D.3.4Pharmaceutical form Suspension for injection
    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.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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.IMP: 3
    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 namePollinex Quattro Birch (900 SU/mL)
    D.3.4Pharmaceutical form Suspension for injection
    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.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    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.IMP: 4
    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 namePollinex Quattro Birch (2000 SU/mL)
    D.3.4Pharmaceutical form Suspension for injection
    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.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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.IMP: 5
    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 namePollinex Quattro Birch (2400 SU/mL)
    D.3.4Pharmaceutical form Suspension for injection
    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.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2400
    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.IMP: 6
    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 namePollinex Quattro Birch (6000 SU/mL)
    D.3.4Pharmaceutical form Suspension for injection
    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.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    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
    Seasonal allergic rhinoconjunctivitis due to birch pollen
    E.1.1.1Medical condition in easily understood language
    Hay fever due to birch pollen
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 100000004853
    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 of this study is to compare the difference between six individual POLLINEX® Quattro (PQ) Birch dose regimen of 5000 SU, 5100 SU, 15000 SU, 15300 SU, 20100 SU and 27300 SU (cumulative doses), and placebo, with regard to the change seen from baseline to post-treatment in TSS recorded following a CPT.
    E.2.2Secondary objectives of the trial
    Efficacy:
    • To compare the effect of treatment with nearly identical cumulative doses of PQ Birch when administered as 4 versus 6 injections on TSS following CPT.
    • To assess the change in immunological responses following different short course PQ Birch treatments, as reflected by the levels of allergen specific immunoglobulins.
    Safety/Tolerability:
    • To assess the safety and tolerability of different short course PQ Birch treatments, including the frequency of adverse events (AE), adverse reaction complexes (ARCs); the total of treatment related injection site and systemic AEs experienced by a subject within a 24 hour period after an injection) and changes in routine clinical laboratory values (chemistry, haematology, urinalysis) and vital signs.
    • To assess the proportion of subjects not completing a treatment regimen due to AEs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged 18 to 60 years inclusive at the time of signing the consent form.
    2. Female subjects are allowed to participate in the study if they are:
    -Not of childbearing potential defined as: postmenopausal (defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause) or
    -Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation).
    -Non-pregnant, non-lactating with negative urinary pregnancy test at all visits leading up to randomisation and who use at least one of the following effective contraception options:
    • Established use (≥ 90 days prior to the study) of hormonal contraceptive. If < 90 days, additional use of one other effective contraception method until 90 days exceeded or,
    • Placement of an intrauterine device or intrauterine system or,
    • Use of double barrier methods of contraception (e.g. male condom with diaphragm, male condom with cervical cap) or,
    • Successful male sterilization of the sole partner (subject must verbally confirm that appropriate post-vasectomy documentation of the absence of sperm in the ejaculate was provided after the procedure) or,
    • True abstinence, when in line with the preferred and usual lifestyle of the subject. Periodic abstinence, such as calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception.
    3. Good general health, as determined by the investigator, based on a medical evaluation, including medical history, physical examination and laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
    4. Positive history of moderate to severe seasonal allergic rhinoconjunctivitis ascribed to birch pollen exposure, requiring treatment for at least the last 2 years prior to the study and severe symptoms of allergic rhinoconjunctivitis in the past birch pollen season as determined by a score of ≥ 5 on the Disease Severity Questionnaire (DSQ).
    5. A positive SPT for birch (wheals of ≥ 3 mm greater than the negative control and histamine (wheal [longest diameter] ≥ 3 mm greater than the negative control) and a negative SPT to the negative control (redness with wheal < 2 mm is acceptable) at screening.
    6. Birch-specific IgE ≥ 2 as documented by a CAP or equivalent specific IgE test at screening.
    7. Positive CPT at Visit 1 or 1a (TSS ≥ 6, adjusted for reference eye score), and positive CPT at Visit 2 to the same birch extract allergen concentration reached at Visit 1. Note: If CPT at Visit 2 is negative, increase allergen concentration step-wise according to procedure until positive test is achieved. If the result can be verified at a second CPT visit within 6-8 days of Visit 2 (i.e. Visit 2a), the subject may be included.
    8. Forced expiratory volume (FEV) in 1 second (FEV1) ≥ 80% of predicted, with a FEV1/forced vital capacity (FVC) ratio ≥ 70% at screening.
    9. The use of medications not excluded in Exclusion Criterion 13will be permitted if they are not expected to interfere with the ability of the subject to participate in the study and provided they have been on a stable regimen (i.e., the same dosage and administration) for 6 weeks prior to Screening.
    10. Understands the implications of trial participation, provide written informed consent, and demonstrate willingness to comply with instructions and attend required study visits.
    E.4Principal exclusion criteria
    1. History of immunological disorders or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment.
    2. Presence of any acute or chronic ocular disorder, other than allergic conjunctivitis, which could interfere with the evaluation of the CPT.
    3. Presence of moderate to severe asthma, characterised by the current use of inhaled steroids at a daily dose above 200 mcg bd and as defined in the Global Initiative for Asthma (GINA) guidelines.
    4. Presence of any skin conditions which might interfere with the interpretation of the SPT results.
    5. Current diagnosis of Type I or II diabetes.
    6. History of allergen-SIT. Exception: the SIT occurred > 5 years before Visit 1, at least one full annual course of SIT was completed and successful effect on symptom control for at least 1 pollen season after treatment was observed.
    7. Treatment with a preparation containing MPL® within 6 months prior to Visit 1.
    8. Moderate to severe upper or lower respiratory infections requiring medication within 14 days of Visit 2 or a diagnosis of sinusitis within 30 days of Visit 2.
    9. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
    10. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication.
    11. Tyrosine metabolism disorders, especially tyrosinaemia and alkaptonuria.
    12. Positive SPT (wheal [longest diameter] ≥ 3 mm greater than the negative control) at Visit 1 to:
    -any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), moulds (Alternaria alternata), or epithelia (cat and dog) and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 (refer to Symptom Intensity Assessment in Section 10.4.4). Exception: Subjects verifying moderate to severe symptoms to cat or dog may be enrolled if the allergen of concern can be avoided until after the post-treatment visit (Visit 8).
    -grass pollen mix and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 (refer to Symptom Intensity Assessment Section 10.4.4). Note: Subjects verifying moderate to severe symptoms to grass may return for re-screening 21 days following the end of grass pollen season and cessation of symptoms. No testing is required if screening occurs following the end of grass pollen season.
    - any of the following autumn flowering plant allergens: mugwort (Artemisia vulgaris), English plantain (Plantago lanceolata) or ragweed (Ambrosia sp.) and positive case history of moderate to severe symptoms to the aforementioned allergens during the 3 years prior to Visit 1 (refer to Symptom Intensity Assessment Section 10.4.4). Note: Subjects verifying moderate to severe symptoms to any autumn flowering plant allergens may return for re-screening 21 days following the end of the relevant allergen season and cessation of symptoms, pending sufficient time for completion of treatment. One or more of the listed allergens must not be tested if uncommon to the Investigator’s region or, if common, screening and treatment can be performed after the end of the allergen season.
    13. Inability to discontinue the use of prohibited medications prior to Visit 1 and to refrain from using prohibited medications/therapies until after completion of Visit 8.
    14. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated).
    15. Clinical history of drug or alcohol abuse which would, at the Investigator’s discretion, interfere with the subject’s ability to participate in the study.
    16. Participation in a clinical research study with a new chemical substance within 4 weeks of Visit 1 or concomitantly with this study.
    17. Personal, financial or other dependent relationship (e.g. employee or immediate relative) with the study site, Sponsor, Sponsor’s representative, or another individual who has access to the clinical study protocol.
    18. Judicial or governmental detention, detainment or imprisonment in a public institution.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to post-treatment in TSS following CPT
    E.5.1.1Timepoint(s) of evaluation of this end point
    77 days
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    · Number of additional allergen concentration steps required to elicit a positive CPT (i.e. TSS
    ≥ 6, adjusted for reference eye score) post-treatment
    · Immunological changes to immunoglobulin levels (birch--specific IgE)
    Secondary Safety Endpoints:
    · Frequency of AEs
    · Frequency of ARCs (the total of treatment related injection site and systemic AEs experienced
    by a subject within a 24-hour period after an injection)
    · Premature discontinuation from treatment or study due to AEs
    · Changes in clinical laboratory values (chemistry, haematology, urinalysis) between screening
    and Visit 8
    · Changes in vital sign parameters at all visits in the treatment period between from preinjection
    to post-injection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    77 days
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Test 4 versus 6 injections of Pollinex Quattro Birch of nearly identical cumulative doses
    E.8.2.4Number of treatment arms in the trial7
    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 concerned27
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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 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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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 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: 350
    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 state301
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 350
    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 Decision2015-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-08
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA