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    Summary
    EudraCT Number:2006-003065-14
    Sponsor's Protocol Code Number:6078-PG-PSC-141
    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:2006-11-24
    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 number2006-003065-14
    A.3Full title of the trial
    Investigation of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add-on therapy in patients with allergic rhinitis and/or rhinoconjunctivitis sensitized to grass pollen
    A.4.1Sponsor's protocol code number6078-PG-PSC-141
    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 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 nameDepigoid Gräser-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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeFreeze-dried depigmented and glutaraldehyde-polymerised allergen extract of the pollen of Phleum pra
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 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
    Intermittent rhinitis and/or rhinoconjunctivitis with or without asthma bronchial caused by clinical relevant sensitisation against grass pollen.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039083
    E.1.2Term Rhinitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is the investigation of the efficacy and safety of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add-on therapy in patients with intermittent allergic rhinitis and/or rhinoconjunctivitis sensitized to grass pollen.

    Primary criterion

    Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the second season)
    E.2.2Secondary objectives of the trial
    Secondary criteria
    ·Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the first season)
    ·Symptom load for asthma (combined symptom and medication scores) in both seasons
    ·Titrated specific nasal challenge test at selected centers
    ·Titrated skin prick test
    ·Symptom scores (rhinitis and/or rhinocojunctivitis and asthma sepa-rately) on a scale from 0-3 (none – severe) in both seasons
    ·Rhinitis/Rhinoconjunctivitis
    ·Obstruction
    ·Sneezing
    ·Rhinorrhea
    ·Nasal itching
    ·Ocular itching
    ·Asthma
    ·Chest tightness
    .Shortness of breath
    ·Cough
    ·Wheezing
    ·Percentage of symptom improvement according to symptom score
    ·Medication scores in both seasons
    ·Rhinitis and/or rhinoconjunctivitis
    ·H1-blocking agent (Xusal®): 1 point per tablet
    ·Nasal steroid (Nasonex®): 2 points per daily dose *
    ·Oral Steroids (Decortin® 50 mg): 3 points per tablet **
    ·Asthma
    [...] for more please refer to protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Prior to study specific examinations the patient has to give his/her written informed consent
    2.Patients (≥ 12 years old) with a history of moderate to severe intermittent rhinitis and/or rhinoconjunctivitis during the grass season according to ARIA classification (28)
    3.Symptoms more than 2 years prior to study start
    4.Detectable specific IgE ≥ 2 CAP RAST to grass pollen at the screening visit (V1) or within the previous 12 months
    5.Positive skin-prick test (wheal diameter of at least 3 mm > negative control; Phleum pollen, 30 HEPL/ml; Laboratorios LETI, S.L, Tres Cantos, Spain)
    E.4Principal exclusion criteria
    Disease specific criteria
    1.History of significant clinical manifestations of allergy as a result of sensitiza-tion against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite)
    For clarification:
    According to the decision tree (see Appendix 3) patients with typical symptoms against the co-allergens birch, house dust mite, cat and dog are not allowed to en-ter 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) according to ARIA classification (29)
    3.Uncontrolled asthma, defined as FEV1 or PEF ≤ 70% of predicted normal value

    Patients with other known concomitant diseases / treatments
    4.Active tuberculosis
    5.Acute and chronic inflammatory or infectious diseases at the target organ effective
    6.Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
    7.Autoimmune disorders (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases)
    8.Immune deficiencies
    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.History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
    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 therapy is 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.SIT against grass pollen within the last 5 years
    16.7 days prior and 14 days post an immunization with vaccines
    17.Anti-allergic treatment within the last 4 weeks prior to screening
    18.b-blocker are not allowed during the entire study and will lead to the patient being withdrawn
    19.Treatment with substances interfering with the immune system are not allowed during the entire study and will lead to the patient being withdrawn
    20.Use of other investigational drugs at the time of enrolment or within 30 days
    21.Treatment with systemic corticosteroids within 3 months prior to the study

    Others
    22.Patients who are expected to be non-compliant and/or not co-operative
    23.Participation in any other clinical study within the last 30 days prior to the start of the study
    24.Patients who have already participated in this study
    25.Patients who are employees at the investigational site, relatives or spouses of the investigator
    26.Any donation of germ cells, blood, organs, or bone marrow during the course of the study
    27.Patients who are not contractually capable

    Special restrictions for female patients
    28.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
    29.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 mIU/m 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 (implant-able, 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)
    The objective of the study is the investigation of the efficacy and safety of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add-on therapy in patients with intermittent allergic rhinitis and/or rhinoconjunctivitis sensitized against grass pollen.

    Primary criterion

    Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the second season)
    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 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.8.3 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 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 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 months7
    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 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) Yes
    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 state195
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    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 Decision2007-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-24
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