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    Summary
    EudraCT Number:2008-003864-20
    Sponsor's Protocol Code Number:P05234
    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:2008-11-19
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-003864-20
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Ragweed (Ambrosia artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma
    A.4.1Sponsor's protocol code numberP05234
    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 SponsorSchering Plough Research Institute, a Division of Schering Corporation
    B.1.3.4CountryUnited States
    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 nameSCH 039641 SL Tablet
    D.3.2Product code SCH 039641
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllergen extract from short ragweed (Ambrosia artemisiifolia)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5, 6, 12
    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 Yes
    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 placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rhinoconjunctivitis due to ragweed allergy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    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 of ragweed sublingual tablet (SCH 39641) versus placebo in the treatment of ragweed-induced rhinoconjunctivitis based on combined (sum of) rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire ragweed season (RS).
    E.2.2Secondary objectives of the trial
    To assess overall long-term safety and to compare the following between the SCH 39641 and placebo groups: 1. The average rhinoconjunctivitis DSS for the entire RS. 2. The average rhinoconjunctivitis DMS for the entire RS. 3. The percentage of minimal symptom days for the entire RS. 4. The average rhinoconjunctivitis quality of life total score for the entire RS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects, of either sex, and of any race, with a clinical history of significant
    ragweed-induced allergic rhinoconjunctivitis (with or without asthma) will be selected for this study
    Key Inclusion Criteria
    1. Subject must be 18 to 50 years of age, of either sex, and of any race
    2. Subject must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more with or without asthma (diagnosed by a physician) and have received treatment for the disease during the previous RS
    3. Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
    4. Subject must be positive for specific IgE against Ambrosia artemisiifolia (≥ IgE Class 2) at the Screening Visit
    5. Subject must have an FEV1 of at least 70% of predicted value at the Screening Visit
    6. A subject’s safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor
    7. A subject must be willing to give written informed consent and be able to
    adhere to dose and visit schedules
    8. Female subjects of childbearing potential must be using a medically
    acceptable and adequate form of birth control. These include:
    a) hormonal contraceptives as prescribed by a physician (oral, hormonal
    vaginal ring, hormonal implant or depot injectable);
    b) medically prescribed intra-uterine device;
    c) medically prescribed topically-applied transdermal contraceptive patch;
    d) double-barrier method (eg, condom in combination with a spermicide).
    9. Female subjects of childbearing potential should be counseled in the
    appropriate use of birth control while in the study. Female subjects who are
    not currently sexually active must agree and consent to use one of the abovementioned methods if they become sexually active while participating in the
    study
    10. Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening Visit in order to be considered eligible for enrollment. Women who have been surgically sterilized or at least 1 year postmenopausal are not considered to be of childbearing potential.
    E.4Principal exclusion criteria
    1. Subject with a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen during or potentially overlapping the RS who has received regular medication for these conditions
    2. Subject with a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the subject is regularly exposed
    3. Subject has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms)
    4. Subject with a clinical history of severe asthma
    5. Subjects with asthma requiring medium or high dose inhaled corticosteroids
    6. Subject with a history of anaphylaxis with cardiorespiratory symptoms
    7. Subject with a history of chronic urticaria and angioedema
    8. Subject with a clinical history of chronic sinusitis during the 2 years prior to the Screening Visit
    9. Subject with current severe atopic dermatitis
    10. Female subject who is breast-feeding, pregnant, or intending to become pregnant
    11. Subject who has had previous immunotherapy treatment with ragweed allergen or any other allergen within the 5 years prior to the Screening Visit
    12. Subject with history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for Ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine
    13. Subject with any clinically significant condition or situation, other than the
    condition being studied that, in the opinion of the investigator, would interfere
    with the study evaluations or optimal participation in the study
    14. Subject who has used any investigational drugs within 30 days of the
    Screening Visit
    15. Subject who is participating in any other clinical study
    16. Subject who is a family member of the investigational study staff conducting
    this study
    17. Subject who is unable to meet specific medication washout requirements
    18. Subject who is unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the RS, which in the opinion of the investigator will compromise the data
    19. Subject with clinically significant abnormal vital sign or laboratory value that
    would preclude participation in the study
    20. A subject participating in this study may not participate in this same study at
    another investigational site
    21. A subject must not be randomized into this study more than once
    22. A subject who is unable to or will not comply with the use of self-injectable
    epinephrine
    23. Subjects who may be at greater risk of developing adverse reactions after
    epinephrine administration
    24. Subject with a history of self-injectable epinephrine use
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the combined (sum of) rhinoconjunctivitis DSS and
    DMS averaged over the entire RS. The combined score for each subject will be calculated as the sum of rhinoconjunctivitis DSS and DMS during the entire RS, divided by the duration of the entire RS.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    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 concerned22
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA22
    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 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 overall study ends when the last remaining subject has completed or has been discontinued from the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=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 state346
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 346
    F.4.2.2In the whole clinical trial 800
    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)
    Once a subject has ended participation in the study, he/she will revert to usual care according to his/her own personal physician.
    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 Decision2009-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-20
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