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    Summary
    EudraCT Number:2006-004222-93
    Sponsor's Protocol Code Number:GPE 02
    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:2006-09-27
    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 number2006-004222-93
    A.3Full title of the trial
    Assessment of the Maximal Tolerated Dose of a Microencapsulated Grass (Phleum pratense) Pollen Extract (MGPE) in Subjects with Grass Pollen Allergy in a Randomized, Double-Blind, Placebo-Controlled Study
    A.3.2Name or abbreviated title of the trial where available
    GPE 02
    A.4.1Sponsor's protocol code numberGPE 02
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorCuralogic A/S
    B.1.3.4CountryDenmark
    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 nameMicroencapsulated grass pollen extract
    D.3.2Product code MGPE
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGrass Pollen Extract (GPE)
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGPE
    D.3.9.3Other descriptive nameGrass pollen extract, Phleum pratense
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000, 2000, 8000 to and 16000 BAU
    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) No
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of seasonal allergic rhinitis to grass pollen.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the maximal tolerated dose of Microencapsulated Grass (Phleum pratense) Pollen Extract (MGPE) in subjects allergic to grass pollen.
    E.2.2Secondary objectives of the trial
    To evaluate safety and tolerability of escalating doses of Microencapsulated Grass (Phleum pratense) Pollen Extract (MGPE).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent;
    2. 18 to 65 years old; both inclusive;
    3. Have a history of two consecutive seasons of summer, seasonal allergic rhinitis from the end of May with a maximum during June and July that has required repeated treatment with antihistamines, leukotriene antagonists, nasal steroids, or topical cromones;
    4. Have a positive skin prick test (SPT) to a standardized grass pollen extract (Phleum pratense) performed within the last six months before screening, which is defined as:
    • Diameter of the weal of at least the size of the positive control (histamine-dihydrochloride) and
    • Diameter of weal of at least 5 mm;
    5. Have a grass-specific (Phleum pratense) IgE concentration of at least 0.7 kU/L using the Phadia ImmunoCAP assay (Freiburg, Germany);
    6. Will be available for visits at the Clinical pharmacology research unit (CPRU) for the duration of the study;
    7. Have a negative blood pregnancy test (women of childbearing potential). Women of childbearing potential, who are sexually active, must be consistently using a highly effective double method of contraception.
    8. Are able to understand the study requirements and comply with study instructions.
    E.4Principal exclusion criteria
    1. Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the data for the IMP or might place the subject at additional risk;
    2. Have a severe autoimmune disease or a severe immunodeficiency;
    3. Have a neoplastic malignancy with present clinical relevance;
    4. Have perennial or structurally related rhinitis, including vasomotor rhinitis, i.e., require treatment of the allergic symptoms with antihistamines or nasal steroids during the months of December and January;
    5. Unable to comply with the study schedule and procedures;
    6. Are currently receiving immunotherapy to any allergens or have received grass immunotherapy within three years before the Screening Visit (immunotherapy to other allergens than grass discontinued within 90 days before the Screening Visit is allowed);
    7. Have moderate to severe persistent asthma (Global Initiative for Asthma, GINA, criteria III and IV) requiring daily "controller" medications (moderate to high doses of inhaled corticosteroids, long-acting bronchodilators, leukotriene antagonists) or use "rescue" medication (salbutamol for inhalation or similar short-acting bronchodilators) more than four times weekly at any time during the year;
    8. Have insufficiently treated asthma and/or irreversible airway obstruction with a value of forced expiratory volume (FEV1) <70% of predicted (mean out of three acceptable values) despite of asthma medication
    9. Repeated or daily use of proton pump inhibitors within one week before the Screening Visit and throughout the study;
    10. Use prohibited medications or have inadequate washout periods before the start of the study. The following medications are prohibited during the study and if taken before the study, the required wash-out periods are indicated in brackets:
    • Oral corticosteroids (one month);
    • Antihistamines:
    o H1-blocker (three days),
    • Anti-lgE medication (six months),
    • Tricyclic antidepressants (14 days);
    11. Have significant chronic sinusitis as assessed by the Investigator;
    12. Have Rhinitis medicamentosa from excessive use of nasal decongestants (e.g., oxymetazoline);
    13. History of hypersensitivity to the IMP or its excipients (subjects enrolled in this study are expected to be allergic to grass). Hypersensitivity to the IMP means that the subject has had a previous systemic or severe local reaction to grass extract previously used for SPT or immunotherapy;
    14. Are pregnant or lactating;
    15. Participation in another study with any IMP in the three months before the study;
    16. Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ;
    17. Blood or plasma donation of more than 500 mL during the month before the study and more than 50 mL within the two weeks before Day 1;
    18. Positive test results for HIV1 and HIV2 virus, or for Hepatitis B surface-antigen (HBsAg ) or Hepatitis C virus antibody;
    19. Current evidence of drug abuse or history of drug abuse within 18 months before the study, including history of alcohol abuse or active alcoholism;
    20. Inability to understand the protocol requirements, instructions and study-related restrictions; the nature, scope, and possible consequences of the study;
    21. Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for Follow-up Visits, and improbability of completing the study;
    22. Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study, both at PAREXEL and at Curalogic;
    23. Vulnerable individuals (e.g., persons kept in detention);
    24. Use of beta-blockers.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events
    • Allergic serious adverse event
    • Severe systemic reaction
    • Diarrhea
    >40% of the subjects on active IMP with ≥Grade I (definite/possible/probable causality to the IMP)
    o >30% of the subjects on active IMP with ≥Grade II (definite/possible/probable causality to the IMP)
    o >10% of the subjects on active IMP with ≥Grade III (definite/possible/probable causality to the IMP)
    • Nausea/Vomiting
    o >10% of the subjects on active IMP with ≥Grade II (definite/possible/probable causality to the IMP)
    Immunoglobulin
    Grass specific immunoglobulin (IgG and IgG4)
    Cellular immune response by grass specific T-cell proliferation
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    N/A
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days88
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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)
    N/A
    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 Decision2006-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-24
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