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    Summary
    EudraCT Number:2005-001099-11
    Sponsor's Protocol Code Number:CIGE025A2425
    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:2005-11-04
    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 number2005-001099-11
    A.3Full title of the trial
    A randomized, open label, parallel-group, international, multicenter study evaluating persistency of response to omalizumab during 32 weeks treatment given as add on to optimized asthma therapy in adult and adolescent patients with severe persistent allergic asthma, who remain inadequately controlled despite GINA (2004) step 4 therapy
    A.4.1Sponsor's protocol code numberCIGE025A2425
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Xolair
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameXolair
    D.3.2Product code omalizumab
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNomalizumab
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe persistent allergic 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 evaluate persistency in treatment responder classification between assessments at 16 and 32 weeks after starting omalizumab therapy given as add on to optimized asthma therapy in patients who remain uncontrolled despite GINA step 4 therapy.
    Treatment response is defined by at least marked improvement of overall asthma control as assessed by physician global evaluation of treatment effectiveness.
    E.2.2Secondary objectives of the trial
    To evaluate persistency in treatment responder classification between assessments at 16 and 32 weeks after randomization to optimized asthma therapy alone in patients who remain uncontrolled despite GINA step 4 therapy.

    To evaluate the effect of omalizumab as add-on to optimized asthma therapy compared to optimized asthma therapy alone : Global Evaluation of Treatment Effectiveness and FEV1 at weeks 16 and 32, rate of clinically significant exacerbations, Asthma Control Questionnaire and meaningful nighttime awakenings at week 16 and 32, rate of hospitalizations (...) for clinically significant and severe asthma exacerbations, reduction of oral corticosteroids dose in patients requiring OCS as maintenance therapy, Quality of life, Work Productivity, Activity Impairment.

    Exploratory : Evaluation of response rate to omalizumab treatment compared to previous double blind trial, Fractional Exhaled Nitric Oxide as non-invasive measure of airway inflammation in a subgroup of patients
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - males or females of any race who are 12-75 years of age
    - body weight 20 to 150 kg and total serum IgE level 30 to 700 IU/ml
    - diagnosis of allergic asthma ≥1 year duration according to ATS criteria and at screening a history consistent with GINA step 3 or 4 clinical features
    - positive skin prick test to at least one perennial allergen documented within the past 2 years or taken at Visit 1. Patients with a total IgE level of ≤ 76 IU require an unequivocal positive RAST test to be eligible
    - demonstrating at least 12% increase in FEV1 within 30 minutes of taking salbutamol
    - FEV1 between 40 and 80% of the predicted normal value for the patient at screening and randomization
    - receiving high dose inhaled corticosteroid ≥ 800μg BDP or equivalent and a regular inhaled long acting beta-2 agonist for at least 3 months prior to screening and > 1000 µg BDP and a LABA for at least 4 weeks during the run-in and at randomization
    - who have suffered at least two independent documented severe asthma exacerbations while receiving high doses of ICS (≥ 800 µg BDP or equivalent) plus regular inhaled LABA requiring treatment with systemic (oral or IV) corticosteroids. Qualifying exacerbations must have taken place in the 3 years prior to screening, and at least one severe exacerbation must have occurred within the previous 12 months
    - with evidence of poor asthma control at screening and for at least 4 weeks immediately prior to randomization
    E.4Principal exclusion criteria
    - pregnant or nursing women, and women of childbearing potential unless they meet the definition of post-menopausal or use one or more acceptable methods of contraception
    Patients :
    - who, for reasons other than asthma, have received systemic corticosteroids within 4 weeks of Visit 1 or are likely to require it during the study for reasons other than asthma
    - not adhering to the antihistamine washout prior to the skin prick tests at Visit 1
    - taking ß adrenergic antagonist medication or anticipate use during the study
    - taking methotrexate, gold salts, cyclosporin or troleandomycin within 3 months of Visit 11 (or anticipated their use during the study)
    - currently receiving desensitization therapy with less than 3 months of stable maintenance doses prior to the screening visit (Visit 1)
    - foreseen to require additional asthma medication during the last 4 weeks of the run-in period
    - being treated for an asthma exacerbation during the 4 weeks immediately prior to randomization
    - with a smoking history > 10 pack years or an active lung disease other than allergic asthma, e.g. COPD
    - with elevated serum IgE levels for reasons other than allergy
    - with significant underlying medical conditions that could impact interpretation of results should be excluded (e.g.: infection, hematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
    - who have previously been randomized into this or any other omalizumab study or who have received omalizumab (prescribed)
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable, persistency rate (%) of response, is based on the investigator’s global evaluation of treatment effectiveness, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    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 Information not present in EudraCT
    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 2005-11-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 379
    F.4.2.2In the whole clinical trial 450
    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)
    After completion of the 32 week treatment period implementation of continued access protocols will be determined on a country by country basis dependent on market authorization of omalizumab and other local requirements. Further information can be obtained from local Novartis offices.
    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 Decision2006-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-25
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