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    Summary
    EudraCT Number:2006-005713-35
    Sponsor's Protocol Code Number:RPE 04
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-23
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-005713-35
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL MICROENCAPSULATED RAGWEED POLLEN EXTRACT ADMINISTERED PRIOR TO AND DURING THE RAGWEED POLLEN SEASON
    A.3.2Name or abbreviated title of the trial where available
    RPE 04
    A.4.1Sponsor's protocol code numberRPE 04
    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 ragweed pollen extract
    D.3.2Product code MRPE
    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 INNRagweed Pollen Extract (RPE)
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeRPE
    D.3.9.3Other descriptive nameRagweed pollen extract, Ambrosia artemisiifolia
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 Amb a 1 units
    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 ragweed 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 evaluate the efficacy and safety of an orally administered MRPE, 40 Amb a 1 units daily, and placebo initiated at least 8 weeks prior to, and continuing throughout, the ragweed pollen season in ragweed allergic subjects.

    The primary efficacy measure will be the average daily Total Symptom Score (TSS) of seven symptoms during the Peak Ragweed Pollen Period.
    E.2.2Secondary objectives of the trial
    To evaluate the treatment effect of MRPE on:

    •Concomitant relief medication adjusted TSS
    •Concomitant allowed relief medication usage
    •Average daily TSS during the ragweed pollen season
    •Rhinoconjunctivitis Quality of Life (US sites only)
    •Global allergy evaluation score
    •Overall Hay Fever (Rhinitis) Condition Score – Visual analog scale (VAS) score
    •Average daily nasal and non-nasal symptom scores
    •Individual symptom scores
    •Proportion of days with minimal symptoms and no concomitant relief medication used to relieve allergy symptoms
    •Serum immunoglobulin levels (Amb a 1 specific IgG, IgG4, and ragweed-specific IgE)
    •Skin test reactivity to ragweed pollen extract
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    Subjects eligible for enrollment into this study are female and males who:
    1. Are between 18 and 65 years of age and are in general good health;
    2. Have a history of two consecutive seasons of fall, seasonal allergic rhinitis that has required repeated treatment with antihistamines, leukotriene antagonists, and/or nasal steroids;
    3. Have a positive puncture skin test to a standardized ragweed (Ambrosia artemisiifolia) pollen extract (≥ 250 Amb a 1 units/ml) with a:
    • Sum of erythema: of at least 40 mm, and
    • Diameter of wheal of at least 5 mm;
    4. Have a ragweed (Ambrosia artemisiifolia) specific IgE level of at least 0.7 kU/L using the Pharmacia & Upjohn ImmunoCAP assay;
    5. Are willing to remain in the study center’s defined ragweed area for the entire pollen season;
    6. Will be available for clinic visits for the duration of the study;
    7. Have a negative urine pregnancy test (women of childbearing potential). In women of childbearing age, who are sexually active, they must be consistently using a highly effective method of birth control (oral contraceptive, intra-uterine device [IUD], condom plus spermicide, Depo-Provera or other acceptable contraceptive methods, [abstinence and celibacy will be accepted only with written confirmation by subject]) for at least one month prior to study entry and will continue to use this method consistently for the duration of the study;
    8. Are able to understand the protocol and comply with study instructions.
    9. Have access to phone line (US sites) or wireless capability (European sites) to transmit electronic diary information.
    E.4Principal exclusion criteria
    1. Are pregnant and/or breast feeding;
    2. Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the efficacy or the safety of the study medication or might place the subject at additional risk;
    3. Have perennial or structurally related rhinitis, including vasomotor rhinitis, that will interfere with the evaluation of symptoms due to ragweed allergy i.e. require treatment of their allergic symptoms with antihistamines or nasal steroids during the months of December and January;
    4. Have a routine sleeping pattern between the hours of approximately 6:00 am to 6:00 pm;
    5. Are currently receiving immunotherapy to any allergens and/or have received ragweed immunotherapy within 5 years of the Screening Visit (immunotherapy to other allergens than ragweed discontinued within 90 days of Screening Visit is allowed);
    6. Are asthmatic requiring daily “controller” medications (inhaled corticosteroids, cromolyn-type drugs, long-acting bronchodilators, leukotriene antagonists) or use “rescue medicines” (albuterol or similar short-acting bronchodilators) more than 4 times per week at any time during the year or has a FEV1<80% of the predicted value;
    7. Have a history of alcohol or drug abuse during the past 18 months;
    8. Use beta-blockers and/or monoamine oxidase (MAO) inhibitors;
    9. Repeated or daily use of proton pump inhibitors within 1 week of the Screening Visit (Pre-Seasonal Visit 1) and throughout study;
    10. Use prohibited medications or have inadequate washout periods prior to the start of the study. The following medications are prohibited and if taken prior to the study, the indicated wash-out periods are applicable:
    • H2-blockers (3 days)
    • Anti-IgE medication, e.g., Xolair (6 months)
    • Tricyclic antidepressants (14 days)
    11. Have presence of significant chronic sinusitis as determined by the Investigator
    12. Have rhinitis medicamentosa from excessive use of nasal decongestants (eg: oxymetazoline);
    13. Have a severe autoimmune disease, immune deficiency
    14. Have a malignant neoplastic disease with current signs of disease
    15. History of hypersensitivity to the Study Drug or its excipients (Patients enrolled in this study are expected to be allergic to ragweed). Hypersensitivity to Study Drug means that they have had a previous systemic or severe local reaction to ragweed extract previously used for skin testing or immunotherapy;
    16. Have previously received MRPE in a clinical trial;
    17. Will travel outside the local ragweed pollen region during the ragweed pollen season (27th August to 31th September (US sites) or 15th August to 19th September (European sites)) for more than 3 consecutive days, or for more than a total of 7 days.
    For Europe additional exclusion criteria will be in force
    18. Sensitized to Mugwort defined as a Mugwort (Artemisia vulgaris) specific IgE measurement of at least 3.5 kU/L using the Pharmacia & Upjohn ImmunoCAP assay;
    19. Sensitized to Alternaria defined as an Alternaria (Alternaria alternata) specific IgE measurement of at least 3.5 kU/L using the Pharmacia & Upjohn ImmunoCAP assay.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure will be the average TSS during the 3 contiguous peak ragweed pollen weeks or the ragweed pollen season if the peak season is less than 3 weeks.

    The TSS will include the following seven symptoms:
    1. Nasal stuffiness/congestion
    2. Nasal discharge/post-nasal drip
    3. Nasal itching
    4. Sneezing
    5. Itchy/burning eyes
    6. Tearing/watering eyes
    7. Itchy throat and/or ears.
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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) 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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 550
    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 Decision2007-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-11-19
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