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    Summary
    EudraCT Number:2008-002264-34
    Sponsor's Protocol Code Number:6078-PG-PSC-168
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-01
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2008-002264-34
    A.3Full title of the trial
    Randomised, double blinded, placebo controlled, parallel group study to
    evaluate efficacy and safety of Depigoid® Grass / Birch Mix in patients with
    allergic rhinitis and/or rhinoconjunctivitis with or without mild intermittent
    asthma.
    A.4.1Sponsor's protocol code number6078-PG-PSC-168
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLETI Pharma GmbH
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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 nameDepigoid Grass / Birch Mix
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSolution 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
    Allergic rhinitis and/or rhinoconjunctivitis with or without mild intermittent asthma caused by clinical relevant sensitisation against grass pollen AND birch pollen.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039097
    E.1.2Term Rhinoconjunctivitis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039095
    E.1.2Term Rhinitis seasonal
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of Safety and Efficacy of Depigoid® Grass / Birch Mix with Placebo during
    two birch pollen and grass pollen seasons in patients with allergic rhinitis and/or
    rhinoconjunctivitis with or without mild intermittent asthma caused by a clinical relevant sensitisation against grass pollen AND birch pollen.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Prior to study specific examinations the patient and if applicable both legal
    guardians has to give his/her written informed consent
    2. Patients of both gender aged from 12 and 70 years
    3. Patient`s perception of disease activity of at least 30 mm on a 100 mm visual
    analogue scale (VAS)
    4. FEV1 of PEF ≥ 70% of predicted normal value under normal conditions
    5. Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against grass AND birch pollen. The IgE mediated sensitization has to be verified by:
    - Suggestive medical history
    - specific IgE against grass AND birch pollen CAP RAST ≥2
    - a positive skin prick test (SPT) or provocation test for grass pollen AND
    birch pollen (SPT resulting in a wheal diameter of at least 3 mm > negative
    control reaction or ‘++’ versus histamine; the provocation test is deemed to
    be negative, if no reaction emerges in consequence to an application of a
    maximum concentration of 1/10 or 1/100). If both tests are performed,
    the result of the NPT will be mandatory.
    E.4Principal exclusion criteria
    Disease specific criteria
    1. History of significant clinical manifestations of allergy as a result of sensitization
    against weed pollen allergens and perennial (e.g. house dust mite)
    For clarification: According to the decision tree (see Appendix 3) patients with typical symptoms against the co-allergens, weed pollen, house dust mite, cat and dog are
    not allowed to enter the trial. Patients without symptoms will enter the trial if they are not exposed to the allergen even if CAP RAST is ≥ 2. In case they are exposed to the allergen they must have a specific CAP RAST < 2 to be able to enter the trial.
    2. Persistent asthma (GINA ≥ II)

    Patients with other known concomitant diseases / treatments
    3. Active tuberculosis
    4. Acute and chronic inflammatory or infectious diseases at the target organ
    5. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
    6. Immunopathological diseases (e.g. of the liver, kidney, the nervous system,
    thyroid gland, rheumatic diseases)
    7. Immune deficiencies
    8. Uncontrolled asthma, defined as FEV1 or PEF ≤ 70% of predicted normal value
    9. Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
    10. Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine
    disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
    11. Malignant disease of any kind during the previous 5 years
    12. Abnormal laboratory parameters and vital signs that could increase the risk to
    the study participant
    13. Alcohol, drug or medication abuse within the past year
    14. Severe psychiatric / psychological / neurologic disorders

    Patients with other known previous / concomitant treatments
    The following therapies are not allowed within the specified period prior to
    screening as well as during the study and will prevent the patient from being
    included into the study:
    15. Participation in an immunotherapy against grass and/or birch pollen with
    comparable extracts within the last five years
    16. Locally and systemically treatment with β-blocker is not allowed during the
    entire study and will lead to the patient being withdrawn
    17. Treatment with substances interfering with the immune system are not allowed
    during the entire study and will lead to the patient being withdrawn
    18. Treatment with tranquilizer or psychoactive drugs
    19. Treatment with systemic corticosteroids within 3 months prior to the study
    20. An immunization with vaccines 7 days prior and 14 days post an injection
    Others
    21. Patients who are expected to be non-compliant and/or not co-operative
    22. Participation in any other clinical study within the last 30 days prior to the
    start of the study
    23. Patients who have already participated in this study
    24. Patients who are employees at the investigational site, relatives or spouses
    of the investigator
    25. Any donation of germ cells, blood, organs, or bone marrow during the course
    of the study
    26. Patients who are not contractually capable Special restrictions for female patients
    27. Pregnant or nursing (lactating) women, where pregnancy is defined as the
    state of a female after conception and until the termination of gestation
    28. Women of child-bearing potential, defined as all women physiologically capable
    of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 MIE/mL or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical
    cap)
    E.5 End points
    E.5.1Primary end point(s)
    Symptom load for rhinitis and/or rhinoconjunctivitis (hierarchically evaluated: after two seasons (1st step) / one season (2nd step) of treatment.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 210
    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 Decision2008-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-05
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