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    Summary
    EudraCT Number:2007-003403-13
    Sponsor's Protocol Code Number:CQAX576A2104
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-003403-13
    A.3Full title of the trial
    A proof of concept study of the effects of QAX576 (an interleukin-13 monoclonal antibody) on allergic inflammation following out of allergy season repeated nasal allergen challenge in subjects with seasonal allergic rhinitis sensitive to Timothy grass pollen.
    A.4.1Sponsor's protocol code numberCQAX576A2104
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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.3.2Product code QAX576
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeQAX576
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeAnti-IL13 Monoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Flixonase Aqueous Nasal Spray
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Nasal spray*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeChemical
    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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Response to nasal allergen challenge in patients with proven seasonal allergic rhinitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of QAX576 on allergic inflammation following repeated nasal allergen challenge (NAC) in subjects with seasonal allergic rhinitis sensitive to Timothy grass pollen – in particular to assess if QAX576 reduces Th2-associated cytokines (IL-4, IL-5 and IL-13) in response to multiple NAC.
    E.2.2Secondary objectives of the trial
    • Enumeration of eosinophils in nasal lavage following nasal allergen challenge • Assess total nasal symptom scores (TNSS) following nasal allergen challenge • Assess pharmacokinetics of plasma QAX576 in subjects with seasonal allergic rhinitis • Assess plasma IL-13 production in subjects with seasonal allergic rhinitis •To perform exploratory pharmacogenetic assessments to examine whether individual genetic variation in genes relating allergic disease correlate with systemic levels of allergic mediators.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy, male and female, non-smoking subjects, aged 18 to 55 years inclusive, with a history of allergic rhinitis consistent with Timothy grass pollen allergy. They must show: • a positive skin prick test to Timothy grass pollen (wheal difference Timothy grass pollen – negative control ≥ 3 mm) at or within the 12 months preceding the screening visit and • pre nasal allergen challenge TNSS ≤ 3 at screening • demonstrate symptomatic worsening (TNSS ≥4 point rise) within 30 minutes after nasal allergen challenge • ability to participate in repeated nasal lavages and nasal filter paper assessments at screening. 2. Body Mass Index (BMI) must be within the range of 18 to 30 kg/m2. Subjects must weigh between 50 and 100 kg (inclusive) to participate in this study. 3. Be otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies. 4. Only post-menopausal and surgically sterilized female subjects are allowed to participate in this study. Post-menopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion and menopause will be confirmed by a plasma FSH > 40 IU/L. Surgically sterilized, female subjects must have had the procedure performed at least 6 months prior to screening and the procedure must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. 5. Male subjects must be using 2 methods of contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit (i.e., refrain from fathering a child in the six (6) months following last study drug administration). 6. Able to communicate well with the Investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    E.4Principal exclusion criteria
    1. Presence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, recent nasal surgery or recent (within 8 weeks prior to screening visit) or recent (four weeks) or ongoing upper or lower respiratory tract infection. 2. Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening and at baseline on Day 1 for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine greater than 500 ng/mL. 3. Presence of any respiratory disease other than a history of mild intermittent asthma not requiring regular treatment and associated with normal lung function (FEV1 ≥ 80% predicted at screening after 6 hour short-acting bronchodilator washout). 4. Inability to perform spirometry or spirometry-induced airflow limitation. 5. Use of any prescription drugs within 4 weeks prior to dosing or OTC drugs within 14 days prior to dosing (particularly oral, inhaled, nasal or injectable corticosteroids, decongestants, anti-histamines, medications with anti-inflammatory effects, any other nasally applied medication) within four (4) weeks prior dosing. Paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF. As required’ short-acting bronchodilator treatment for mild intermittent asthma is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF. Use of multivitamin and/or mineral preparations, if taken before, to be avoided since the screening visit. 6. If the subject gives a history of having received immunotherapy in the past 3 years as therapy or as part of a clinical trial.. 7. History or presence of any surgical or medical condition which, in the opinion of the investigator, may jeopardize the subject in case of participation in the study. 8. Significant illness within two weeks prior to dosing. 9. A past medical history of clinically significant ECG abnormalities. 10. History of autonomic dysfunction (e.g., history of fainting, orthostatic hypotension). 11. History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug. 12. Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation. 13. History of immunodeficiency diseases, including a positive HIV test result. 14. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. 15. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening evaluations. 16. History or laboratory evidence of acute or chronic renal insufficiency or abnormal liver function. 17. History of clinical schistosomiasis, or stool examination positive for ova or parasites, or travel within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast and Southwest Asia and Africa. 18. Any planned travel to endemic areas within 6 months following end of study. 19. If blood absolute eosinophil count at screening ≥350 cells/mm3, subjects may be included in the study only after active parasitic infection is ruled out as the etiology of eosinophilia. 20. History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products. 21. Pregnant or lactating female subjects. 22. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis will be the analysis of IL-5 concentrations from the nasal filter adsorption 6 h post nasal allergen challenge on Day 8 and Day 15. The log transformed IL-5 levels from the QAX576 and Placebo group will be analyzed using a mixed model with fixed effects for treatment (QAX576, Placebo), day (Day 8, Day 15), treatment*day interaction and a random effect for subject. The log transformed IL-5 concentration from the nasal filter adsorption 6 h post the last pre-dose nasal allergen challenge will be included in the model as a covariate for baseline adjustment. Estimates for the treatment contrasts “QAX576 – Placebo” on Day 8 and Day 15 will be provided together with 90% confidence intervals. The primary contrasts are the “QAX576 – Placebo” differences on Day 8 and 15 which will be tested for statistical significance using one sided t-tests at the multiplicity adjusted 10% alpha level. Since there are two primary contrast, p-values will be adjusted for multiplicity using the method based on the simulated distribution of the maximum of the two t-statistics (Westfall, Young 1993).
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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) Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Study completion visit is end of trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    Standard treatment for allergic rhinitis
    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 Decision2007-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-07
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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