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    Summary
    EudraCT Number:2019-001517-16
    Sponsor's Protocol Code Number:PQGrass306
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-13
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-001517-16
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of PQ Grass in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised efficacy and safety clinical trial of PQ Grass in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen
    A.4.1Sponsor's protocol code numberPQGrass306
    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 AddressLeopoldstr. 175
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80804
    B.5.3.4CountryGermany
    B.5.6E-mailpqgrass306@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 namePQ Grass
    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.3.8INN - Proposed INNMODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.2Current sponsor codePQGrass
    D.3.9.3Other descriptive nameGRASS POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB186988
    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 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.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 namePQ Grass
    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.3.8INN - Proposed INNMODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.2Current sponsor codePQGrass
    D.3.9.3Other descriptive nameGRASS POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB186988
    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 number2700
    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.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 namePQ Grass
    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.3.8INN - Proposed INNMODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.2Current sponsor codePQGrass
    D.3.9.3Other descriptive nameGRASS POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB186988
    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 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 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 rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure
    E.1.1.1Medical condition in easily understood language
    grass pollen 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 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
    Efficacy: To evaluate the efficacy of PQ Grass 27600 SU in subjects with grass pollen induced SAR and/or rhinoconjunctivitis based on symptoms and medications.
    Safety: To evaluate the safety and tolerability of PQ Grass in subjects with grass pollen induced SAR and/or rhinoconjunctivitis.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of PQ Grass 27600 SU on IgG4.
    To evaluate the potential of PQ Grass 27600 SU to eliminate symptom burden and the need for medication use.
    To evaluate the quality of life.

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker study as described in protocol. To evaluate changes in nasal, serum and/or functional and/or cell-based biomarkers in a subset of subjects at selected clinical trial sites in Germany, and to explore their relationship to the clinical outcome.
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent
    2. Subject who has signed and dated the ICF.
    3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
    4. Male or female.
    5. Female subjects who are not of childbearing potential or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol
    6. Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass pollen of at least 2 seasons duration.
    For Detailed list see the protocol

    E.4Principal exclusion criteria
    1. Pregnant or lactating subject.
    2. Presence of any medical history of moderate to severe allergy symptoms (verified by a positive SPT or positive specific IgE [≥2]* at screening) to any other seasonal allergen (other than grass) or perennial allergens.
    *Please note: The specific IgE testing mentioned above is applicable only in EU for Cockroach and Ash allergens.
    3. Subjects with a positive SPT at US sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure.
    4. Moderate to severe symptoms during the 3 years prior to Visit 1 to any other seasonal or perennial allergen not tested in the SPT done at screening that cannot be avoided during the Period 1 to Period 3 of the clinical trial and the symptoms of which may interfere with administration of treatment and/or impact the data collected.
    5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
    6. Presence of active systemic autoimmune disorder, systemic autoimmune disorders in remission or active organ specific autoimmune disorder.
    7. Presence of active malignant neoplasia, severe cardiovascular disease (e.g., coronary artery disease, cardiac insufficiency, etc.), pulmonary insufficiency, severe psychiatric disorders or primary and secondary immunodeficiencies.
    8. History of any other immunological disorder or other diseases that in the opinion of the Investigator may pose a safety risk or compromise the interpretation of efficacy of the clinical trial treatment.
    9. Presence of severe or poorly controlled or uncontrolled asthma as defined by at least 1 of the following criteria:
    a. Severe asthma (as per the current GINA guidelines [GINA, 2021]).
    b. Uncontrolled or poorly controlled asthma as per the current GINA guidelines (GINA, 2021).
    c. Asthma that requires more than a daily dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroid) as per the current GINA guidelines (GINA, 2021).
    d. History of 2 or more systemic corticosteroid courses within 6 months of screening or Visit 2 or 1 course of systemic corticosteroids within 3 months of screening or Visit 2 to treat asthma.
    e. Prior intubation/mechanical ventilation for asthma.
    f. Emergency room visit or hospitalisation for asthma in the 12 months prior to screening or Visit 2.
    g. Any history of a life-threatening asthma attack.
    h. FEV1 <70% of predicted or FEV1/FVC ≤75% or PEFR <70% of predicted with or without controller medications at screening or Visit 2.
    For Detailed List see the Protocol
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: CSMS averaged over the peak GPS
    Safety: Frequency, severity and relationship of AEs to treatment.
    Frequency of AEs leading to premature discontinuation from treatment or clinical trial.
    Frequency of AESI.
    Changes in clinical laboratory values (serum chemistry, haematology and urinalysis) between screening and Visit 11.
    Changes in vital signs at all treatment visits
    E.5.1.1Timepoint(s) of evaluation of this end point
    daily / during the GPS / during the course of the study as indicated in the protocol
    E.5.2Secondary end point(s)
    Efficacy: Serum grass specific IgG4 at Visit 7 compared to baseline.
    The number of well days during the peak GPS.
    RQLQ(S) measured within the peak GPS.
    Safety: Frequency, severity and relationship of AEs to treatment.
    Frequency of AEs leading to premature discontinuation from treatment or clinical trial.
    Frequency of AESI.
    Changes in clinical laboratory values (serum chemistry, haematology and
    urinalysis) between screening and Visit 11.
    Changes in vital signs at all treatment visits
    E.5.2.1Timepoint(s) of evaluation of this end point
    daily / during the GPS / during the course of the study as indicated in the protocol
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Austria
    Czechia
    Germany
    Hungary
    Poland
    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
    The End of the study is defined as the date of last 6 months telephone follow up call of the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 1084
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state311
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 900
    F.4.2.2In the whole clinical trial 1204
    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)
    At the end of study participation, subjects will be treated according to local practices.
    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 Decision2022-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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