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    Summary
    EudraCT Number:2008-001659-24
    Sponsor's Protocol Code Number:OC000459/010/07
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-15
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-001659-24
    A.3Full title of the trial
    A dose-finding study of the effects of OC000459 on responses to allergen challenge in the Vienna chamber in subjects known to suffer from grass pollen induced allergic rhinitis: a randomised, double-blind placebo-controlled, parallel group evaluation of the dose response curve and minimum effective dose given orally for eight days
    A.4.1Sponsor's protocol code numberOC000459/010/07
    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 SponsorOxagen Ltd.
    B.1.3.4CountryUnited Kingdom
    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 nameOC000459 tablet
    D.3.2Product code OC000459
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeOC000459
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 2
    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 nameOC000459 tablet
    D.3.2Product code OC000459
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeOC000459
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboTablet
    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
    Allergic rhinitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to explore the efficacy of a range of doses of OC000459 when subjects are challenged with allergen in the Vienna Challenge Chamber for 6 hours.
    E.2.2Secondary objectives of the trial
    •To assess the safety of this treatment schedule in male and female subjects with allergic rhinitis.
    •To assess plasma levels of OC000459 at the time of allergen challenge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years. Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening. Acceptable contraception includes the use of TWO of the following: oral contraception (i.e. the Pill); intrauterine device (an IUD or ‘Coil’); barrier contraception (i.e. condoms or diaphragm/cap); transdermal patch
    2. Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by case history, physical examination and screening investigations.
    3. FEV1 within normal limits (≥ 90% of predicted).
    4. Atopy defined by a positive cutaneous response (wheal ≥ 3mm compared to negative control) to mixed grass pollen within the last 12 months or at screening.
    5. Asymptomatic at screening as characterized by a total nasal symptom score of <4 at screening and on Day 1 of the treatment period.
    6. Non smokers for at least the past 3 months with a pack history ≤ 1 pack years (Pack years = (No of cigarettes smoked/day/20) x No of years smoked).
    7. A total nasal symptom score of at least 6 after challenge with up to 1500 grass pollen grains/m3 after 2 hours in the Vienna Challenge Chamber at the screening visit
    8. A positive Radio Allergen Sorbent Test (≥ class 2) for grass pollen at the screening visit or in the previous 12 months.
    9. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    10. Available to complete the study.
    11. Subjects with a negative urinary drugs of abuse screen, determined at screening
    12. Negative carbon monoxide test (smokerlyzer) or urinary cotinine test determined at screening
    13. Negative alcohol breath test determined at screening
    14. Subjects with a 12-lead electrocardiogram (ECG) that is normal or without clinically-significant abnormalities determined at screening by the principal investigator or designee.
    15. Negative test for HIV and Hepatitis B and C determined at screening.
    E.4Principal exclusion criteria
    1. Medical conditions likely to affect the outcome of the study.
    2. Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee.
    3. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
    4. Immunotherapy treatment course in the past 28 days
    5. Use of inhaled or local corticosteroids in the past 28 days.
    6. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator or designee, would limit compliance with the protocol.
    7. Infection of the upper airways/lower airways, sinus, or ear, including viral infections in the 14 days prior to screening and at the start of the treatment period.
    8. Clinically significant abnormality in clinical laboratory tests at screening as determined by the principal investigator or designee.
    9. The subject has participated in a study with a new molecular entity (drug not currently marketed) during the previous four months or any other trial during the previous three months.
    10. The subject regularly, or on average, drinks more than four units of alcohol per day. One unit of alcohol is defined as a medium (125ml) glass of wine, half a pint (250ml) of beer or one measure (24ml) of spirits)
    11. A history of gastrointestinal disorder likely to influence drug absorption.
    12. Receipt of forbidden prescribed or over the counter medication within 14 days of the first study day and for the duration of the trial, including vitamins and herbal remedies.
    13. Inability to communicate well with the investigator (i.e. language problem, poor mental development or impaired cerebral function).
    14. Donation of 450ml or more blood within the previous 12 weeks.
    15. A history of hypersensitivity and/or idiosyncrasy to any of the excipients employed in this study.
    16. Subjects known to have tuberculosis.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Total nasal symptom score on Day 8.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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
    The study will end when the last subject completes the follow up visit (visit 4).
    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 months2
    E.8.9.1In the Member State concerned days14
    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 Information not present in EudraCT
    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 state105
    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 Decision2008-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-07
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