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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2012-001914-41
    Sponsor's Protocol Code Number:AL1201AV
    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:2012-07-03
    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 number2012-001914-41
    A.3Full title of the trial
    Open label phase II multicentre clinical trial to evaluate safety during shortened uptitration of an allergoid grass pollen preparation in adult patients with IgE mediated allergic rhinitis / rhinoconjunctivitis with or without controlled bronchial asthma
    Offene, multizentrische klinische Phase-II-Studie zur Bewertung der Sicherheit einer verkürzten Aufdosierung mit einem Gräserpollen Allergoid Präparat in erwachsenen Patienten mit IgE vermittelter allergischer Rhinitis / Rhinokonjunktivitis mit oder ohne kontrolliertem bronchialem Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety study comparing 2 uptitration schemes with Allergovit® grasses
    Allergoid-Gräserpollen, verkürzte Aufdosierung, Phase-II-Sicherheitsstudie
    A.3.2Name or abbreviated title of the trial where available
    Allergoid-Grass pollen, shortened uptitration phase II safety study
    A.4.1Sponsor's protocol code numberAL1201AV
    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 SponsorAllergopharma Joachim Ganzer KG
    B.1.3.4CountryGermany
    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 supportAllergopharma Joachim Ganzer KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergopharma Joachim Ganzer KG
    B.5.2Functional name of contact pointClinical Trials Department
    B.5.3 Address:
    B.5.3.1Street AddressHermann-Koerner-Straße 52
    B.5.3.2Town/ cityReinbek
    B.5.3.3Post code21465
    B.5.3.4CountryGermany
    B.5.4Telephone number004904072765340
    B.5.5Fax number004904072765600
    B.5.6E-maildietrich.haefner@allergopharma.de
    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 Allergovit® Grasses
    D.2.1.1.2Name of the Marketing Authorisation holderAllergopharma J. Ganzer KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAllergovit® Grasses
    D.3.2Product code 553a/91a-b
    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 INNAllergovit® Grasses
    D.3.9.3Other descriptive nameALLERGENS, POLLEN & PLANT EXTRACT
    D.3.9.4EV Substance CodeSUB12787MIG
    D.3.10 Strength
    D.3.10.1Concentration unit PNU/ml protein nitrogen units/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 5000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ICD classificationcode: J 45.0 and J30.1
    Patients with IgE mediated allergic rhinitis / rhinoconjunctivitis with or without controlled bronchial asthma
    E.1.1.1Medical condition in easily understood language
    Patients suffering from seasonal allergic rhinoconjunctivitis with or without asthma caused by grass pollen
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to obtain information about the safety and tolerability of uptitration with 4 injection (shortened uptitration - Group I) and 7 injections (standard uptitration - Group II), respectively, of Allergovit® grasses.
    E.2.2Secondary objectives of the trial
    Exploratory immunological parameters will be evaluated at the centre of the co-ordinating investigator. The aim is to evaluate assays within the context of a controlled immunotherapy trial to obtain measures of variability and reliability in order to make these parameters potentially available for future trials as additional endpoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has the patient given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.)
    2. Is the patient a legally competent male or female outpatient?
    3. Is the patient aged 18 to 65 year?
    4. Does the patient suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma caused by grass pollen documented by
    • 4 a) Skin prick test wheal for grass pollen ≥ 3mm in diameter
    • 4 b) Histamine wheal ≥ 3mm
    • 4 c) NaCl control reaction < 3mm
    5. IgE result ≥ 0.70 kU/L to grass pollen
    6. Has the patient main discomfort due to allergic rhinoconjunctivitis in the months with grass pollen exposure?
    7. In case of bronchial asthma at entry: Has the patient a confirmed diagnosis of asthma?
    8. In case of a diagnosed asthma, is the asthma classified as being “controlled” according to GINA guidelines (GINA, 2006)?
    9. Has the patient been treated with anti-allergic medications for at least 2 years prior to enrolment? (Patients with perennial and continuously treated asthma have to be excluded, see “exclusion criteria” below.)
    E.4Principal exclusion criteria
    General criteria:
    1. Is the patient unable to understand and comply with the requirements of the trial, as judged by the investigator?
    2. Is the patient currently participating in any other trial or has the patient participated in any other trial within 30 days before inclusion in this trial?
    3. Does the patient show low compliance or inability to understand instructions/trial documents?
    4. Is/was the patient involved in the planning and conduct of the trial?
    5. Is the patient an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites?
    6. Is the patient in any relationship of dependence with the sponsor and/or with the investigator?
    7. Has the patient been previously enrolled or randomised to treatment in the present trial?
    8. Is the patient mentally disabled?
    9. Is the patient institutionalised due to an official or judicial order?

    For females with childbearing potential (i.e. females who are not chemically or surgically sterilised or females who are not post-menopausal):
    10. Does the patient have a positive pregnancy test at screening?
    11. Does the patient use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator? (Reliable and highly effective methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correctly are, e.g., implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partners.)
    12. Is the patient pregnant or wishes to breast feed?
    13. Is the patient seeking to become pregnant?

    Immunotherapy criteria:
    14. Has the patient undergone previous specific immunotherapy with grass pollen allergens in any formulation?
    15. Is the patient currently undergoing any sort of immunotherapy?

    Other allergies:
    16. Has the patient an (anamnestically confirmed) clinically relevant sensitisation to
    a) Dermatophagoides farinae
    b) Dermatophagoides pteronyssinus
    c) birch pollen,
    d) alder pollen,
    e) hazel pollen
    and is any of the Skin Prick Test results greater than the result for grass pollen?

    17. Has the patient an (anamnestically confirmed) clinically relevant sensitisation to
    a) cat epithelia
    b) dog epithelia
    c) Dermatophagoides farinae
    d) Dermatophagoides pteronyssinus
    e) birch pollen,
    f) alder pollen,
    g) hazel pollen
    and is any of the spec. IgE results greater than the result for grass pollen?

    Diseases and health status:
    18. Has the patient a PEF or FEV1 < 80% of predicted normal (ECSC)?
    19. Does the patient suffer from perennial asthma?
    20. Has the patient uncontrolled or partly controlled asthma according to GINA guidelines (GINA, 2006)?
    21. Does the patient suffer from rhinoconjunctival atopy symptoms for 20 years or longer?
    22. Does the patient suffer from severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure, active Tuberculosis), severe inflammatory diseases (liver, kidneys)?
    23. Does the patient suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies (e.g. HIV, post-transplant patients, lupus erythematodes [SLE], Grave’s disease, Hashimoto’s thyroiditis, Multiple Sclerosis)?
    24. Does the patient suffer from severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)?
    25. Does the patient suffer from recurrent seizures?
    26. Has the patient any laboratory value greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) (FDA, 2007)?

    Medications:
    27. Is the patient treated with beta-blockers (locally and systemically)?
    28. Has the patient any contraindication for use of adrenalin (e.g. acute or chronic symptomatic coronary heart disease, severe hypertension)?
    29. Has the patient completed or is he under ongoing treatment with anti-IgE-antibody?
    30. Has the patient completed or is he under ongoing long-term treatment with tranquilizer or other psychoactive drugs?
    E.5 End points
    E.5.1Primary end point(s)
    As this study is a safety study, no efficacy endpoints will be evaluated.
    The aim of the study is to obtain information about the safety and tolerability of uptitration with 4 and 7 injections, respectively, of Allergovit® grasses.

    To achieve this goal, the following safety variables will be considered:
    • the numbers, incidence, type and intensity of local adverse events, adverse events and serious adverse events by MedDRA primary SOC and Preferred Term,
    • adverse events as described above but considered to be related to trial medication by the investigator,
    • the incidence and intensity of systemic anaphylactic reactions after injections according to the WAO grading system,
    • the change of laboratory values (hematology, clinical chemistry and urinalysis) measured before and after the treatment phase,
    • the change of vital signs and lung function measured before, during and after treatment,
    • number and size of local reactions at the injection site < 5 cm, and
    • an assessment of the overall tolerability by the investigator and the patient using a 5 point Likert scale (Likert, 1932)
    E.5.1.1Timepoint(s) of evaluation of this end point
    uptitration period will be evaluated at study end.
    E.5.2Secondary end point(s)
    Exploratory immunological parameters will be evaluated at the centre of the co-ordinating investigator (see section 2.2).
    The aim is to evaluate assays within the context of a controlled immunotherapy trial to obtain measures of variability and reliability in order to make these parameters potentially available for future trials as additional endpoints.

    • The kinetics, magnitude and onset T-cell activation markers (CD69+ and CD103+) will be assessed by flow cytometry
    • T-cell derived cytokine production will be determined by IL-4 and IFN-gamma ELISPOT at start and maintenance of SCIT
    • Mucosal RNA-content in swabs will be determined
    • Mucosal frequency of T-cells (CD3+) during the course of SCIT will be determined using flow cytometry
    E.5.2.1Timepoint(s) of evaluation of this end point
    o at visit T1/1 (after randomisation but prior to first injection)
    o prior to injection with maximum dose normally administered at visit T1/4 group I or visit T1/7 group II, respectively
    o 6h after injection with maximum dose normally administered at visit T1/4 group I or visit T1/7 group II, respectively
    o before the last treatment injection (normally at visit T1/9)
    o 6h after the last treatment injection (normally at visit T1/9)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Same IMP with 2 deferent uptitration schemes: 4 injections compared to 7 injections
    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 concerned12
    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 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 planned end of the trial is defined as the database lock in order to permit the data cleaning procedure after the last visit of the last patient was performed within the trial.
    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 months10
    E.8.9.1In the Member State concerned 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: 120
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 the trial the investigator has to decide on the further individual treatment of each patient. The sponsor will not provide any further treatment after the end of study participation.
    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 Decision2012-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-25
    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-Mon Apr 29 21:47:17 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA