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    Summary
    EudraCT Number:2007-004653-29
    Sponsor's Protocol Code Number:CIGE025A2432
    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:2008-01-30
    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 ConcernedGermany - PEI
    A.2EudraCT number2007-004653-29
    A.3Full title of the trial
    A randomized, multi-center, double-blind, placebo-controlled, parallel-group trial to explore the effects of 78 weeks omalizumab treatment as add on therapy on airway inflammation and remodeling in patients with moderate to severe IgE-mediated asthma receiving inhaled corticosteroids and long acting beta-agonists
    A.4.1Sponsor's protocol code numberCIGE025A2432
    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 Yes
    D.2.1.1.1Trade name Xolair 150 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd, Horsham, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOmalizumab
    D.3.2Product code IGE025
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmalizumab
    D.3.9.1CAS number 242138-07-4
    D.3.9.2Current sponsor codeIGE025
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 typemonoclonal antibody; anti-IgE mAb
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    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 investigate the effect of 78 weeks omalizumab treatment on airway inflammation in moderate to severe allergic asthma patients with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. The primary endpoint supporting this objective will be the number of sub-epithelial eosinophils following 78 treatment with omalizumab, compared to placebo, as assessed in bronchial biopsy samples.
    E.2.2Secondary objectives of the trial
    To investigate the effect of 78 weeks omalizumab treatment on other markers of airway inflammation. The secondary endpoints supporting this objective will be the number of sub-epithelial mast cells and CD4+ T-lymphocytes following 78 treatment with omalizumab, compared to placebo, as assessed in bronchial biopsy samples.
    To investigate the effect of 78 weeks omalizumab treatment on airway remodeling. The secondary endpoint supporting this objective is the thickness of the lamina reticularis, compared to placebo, as assessed in bronchial biopsy samples.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. patients who have been informed of the study procedures and medications and have given written informed consent

    2. who are 18 - 75 years of age and are considered fit to undergo bronchoscopy by the investigator

    3. with a body weight ≥ 20 kg and ≤ 150 kg and with a serum total IgE level ≥ 30 to ≤ 700 IU/ml. The combination of body weight and serum total IgE level must fall within the dosing cells of the approved European dosing tables (Table 6-1 and 6-2)
    4. patients with moderate to severe allergic asthma, with persistent symptoms despite receiving an inhaled corticosteroid and long acting beta-agonist (i.e. Step 4 or 5 treatment as per 2006 GINA guidelines – Appendix 3)

    5. with ≥ 2% eosinophilia in induced sputum at visits 1 and 2

    6. with a positive skin prick test (diameter of wheal ≥ 3 mm) or RAST test to at least one perennial aeroallergen, excluding molds (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of
    the study.

    7. A RAST test may be performed for patients with a borderline skin prick test result. Patients with a total IgE level of ≤ 76 IU/mL require an unequivocal positive RAST test (>71 IU/mL; Class 2+) to be eligible. Skin prick test procedures can be found in Appendix 6

    8. with a post-bronchodilator FEV1 ≥60% of the predicted normal value for the patient, demonstrable 15 minutes after the patient receives 400mcg of salbutamol (or equivalent), at Visit 1. FEV1 % predicted must be stable (within 10%) at the second screening visit (Visit 2) and the randomization visit (Visit 3)

    9. receiving moderate to high dose inhaled corticosteroid ≥ 800μg per day BDP or equivalent, as monotherapy or fixed dose combination, and a regular inhaled long acting β-2 agonist at stable doses for at least 3 months prior to
    screening
    E.4Principal exclusion criteria
    1. Female of childbearing potential (more details are provided in the protocol)
    2. Patients under other therapies/medications:
    • who do not adhere to the following antihistamine washout prior to the skin prick tests at Visit 1 (short and medium acting antihistamines may be used during the study, but wash out is required prior to the skin prick testing):
    - short acting antihistamines (e.g.: chlorpheniramine, promethazine, diphenhydramine, terfenadine) within 3 days of Visit 1
    - medium acting antihistamines (e.g.: loratadine, cetirizine, fexofenadine) within 5 days of Visit 1
    • who are receiving:
    - ß adrenergic antagonist medication (e.g.: propranolol) or anticipate use during the study
    - methotrexate, gold salts, cyclosporin or troleandomycin within 3 months of Visit 1 or anticipate their use during the study
    - desensitization therapy with less than 3 months of stable maintenance doses prior to the screening visit (Visit 1)
    - who have received omalizumab previously
    3. Concurrent diseases/conditions and history of other diseases/conditions as detailled in the protocol
    4. Investigational drug/therapy use as detailled in the protocol
    5. Ingredient hypersensitivity as detailled in the protocol
    6. Compliance, reliability and investigator judgment as detailled in the protocol
    7. Exclusion criteria for flexible fiberoptic bronchoscopy as detailled in the protocol (additional exclusion criteria added in the Protocol amendment 02)
    E.5 End points
    E.5.1Primary end point(s)
    The number of tissue sub-epithelial eosinophils following 78 weeks treatment.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    Last visit of the past patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-01-30. Yes
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 96
    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)
    No different from the expected normal treatment of that condition
    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 Decision2008-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
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