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    Summary
    EudraCT Number:2007-001013-41
    Sponsor's Protocol Code Number:CIGE025A2210
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-001013-41
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to demonstrate the efficacy of Xolair in an allergen bronchoprovocation study in two asthmatic populations defined by serum IgE concentrations
    A.4.1Sponsor's protocol code numberCIGE025A2210
    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 SponsorNovartisPharma 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
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm UK Ltd
    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.3.4Pharmaceutical form Powder 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.3.11 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 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 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 placeboPowder 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 demonstrate that two groups of allergic asthmatic patients with lower and higher IgE, defined by serum IgE of 30-300 IU/mL (Group 1- standard IgE group) and 700-2000 IU/mL (Group 2-high IgE group) can be similarly protected from allergen-induced bronchoconstriction by omalizumab. The primary endpoint supporting this objective will be the change in the early-phase allergic response in omalizumab treated groups in comparison to placebo. The secondary endpoint supporting this objective will be the change in the late-phase allergic response in omalizumab treated groups in comparison to placebo
    E.2.2Secondary objectives of the trial
    Explore if the impact of Omalizumab on specific IgE (derived from the relationship of baseline and free IgE after Omalizumab administration) correlates with the observed effects on reducing airways response to allergen challenge. In those patients demonstrating a late phase response at baseline, inhibition of the late phase response will be analyzed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female (post menopausal or surgically sterilized or using approved barrier or hormonal contraception) patients with intermittent, mild persistent or moderate persistent, aged 18-65 years.

    Diagnosis with asthma with FEV1 of ≥ 65% (pre-bronchodilator) of the predicted value for height, race, age, and sex.

    Asthma exacerbation-free for ≥ 4 weeks

    Otherwise healthy patients except for diagnoses related to allergy or asthma

    Body weight between 40 and 150 kg

    24 subjects in Group 1 will have IgE levels between 30 IU/mL and 300 IU/mL; 24 subjects in Group 2 will have IgE levels between 700 IU/mL and 2000 IU/mL; 10 patients in Group 3 will have IgE levels between 301 IU/mL and 699 IU/mL and bodyweight ≤ 150 kg.

    Patients must have well-characterized positive skin reactivity to a specific allergen within 2 years prior to screening (this allergen will be used for bronchoprovocation testing).

    Patients must also demonstrate a PD20 response to methacholine in the inhaled bronchoprovocation test prior to participating in allergen bronchoprovocation testing (ABP)

    Patients must demonstrate a PD20 response to an aeroallergen in the graded ABP at screening.

    Be able to provide written informed consent
    E.4Principal exclusion criteria
    Current active smokers with ≥5 pack-year smoking history

    Asthma exacerbation requiring treatment with oral or IV corticosteroids in the past 3 months

    Medical conditions that may interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.

    Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study.

    History of asthma attack requiring a visit to an emergency room in the 6 weeks before or during Screening

    History of asthma attack requiring treatment with intubation and mechanical ventilation in the 12 months before Day 1

    History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.

    History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.

    A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

    History of intolerance to methacholine or allergen bronchoprovocation

    Elevated IgE due to suspected parasitosis

    History of bleeding disorders; prior serious bleeding, low platelet counts, anticoagulant

    Allergen Immunotherapy may not be started during this study. It is permitted to continue ongoing allergen immunotherapy at stable doses during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint supporting this objective will be the change in the early-phase allergic response in omalizumab treated groups in comparison to placebo. The secondary endpoint supporting this objective will be the change in the late-phase allergic response in omalizumab treated groups in comparison to placebo.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    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 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
    Last visit of the last patient
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 58
    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 Decision2007-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
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