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    Summary
    EudraCT Number:2006-005917-36
    Sponsor's Protocol Code Number:CIGE025C2303
    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:2007-07-19
    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 number2006-005917-36
    A.3Full title of the trial
    An open label, single arm study to assess the safety and immunogenicity of omalizumab liquid administered subcutaneously in a pre-filled safety syringe (75 mg or 150 mg) over a period of 6 months to male and female adolescents and adults with moderate to severe persistent allergic asthma
    A.4.1Sponsor's protocol code numberCIGE025C2303
    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.3.1Product nameomalizumab liquid formulation 75 mg
    D.3.2Product code IGE025
    D.3.4Pharmaceutical form 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 number75
    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 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 nameomalizumab liquid formulation 150 mg
    D.3.2Product code IGE025
    D.3.4Pharmaceutical form 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 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
    moderate to severe persistent allergic asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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 immunogenic potential of omalizumab liquid when administered over a period of 6 months to omalizumab naïve, moderate to severe persistent allergic asthma patients age 12 years or older.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of omalizumab liquid when administered over a period of 6 months to omalizumab naïve, moderate to severe persistent allergic asthma patients age 12 years or older.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. male or female patients (or as appropriate whose legal guardian) informed of the study procedures and medications and have given written informed consent

    2. 12 years of age or older

    3. body weight ≥ 30 kg and ≤ 150 kg and total serum IgE level ≥ 30 to ≤ 700 IU/ml (consistent with the USPI – dosing table provided in Tables 6-1 and 6-2)

    4. patients with a diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society [ATS] criteria (14) and at screening a history consistent with clinical features of moderate to severe persistant asthma according to [NHLBI June 2002] guidlines (see Appendix 3)

    5. positive skin prick test (diameter of wheal ≥ 3 mm) to at least one perennial allergen (dust mite: dermatophagoides pteronyssinus and dermatophagoides farinae, cat/dog dander, cockroaches - standardized skin prick test supplies to be provided); within the previous 1 year prior to Visit 1 or taken at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. A ImmunoCap/RAST test may be performed for patients with a borderline skin prick test result, only after consultation with Novartis Clinical personnel for approval. See Appendix 5 for skin prick testing procedures.

    6. patients with no clinically significant asthma exacerbations which require treatment with systemic corticosteroids during the 4 weeks immediatly prior to screening visit (Visit 1) and during screening period (between Visit 1 and 2)

    7. demonstrate evidence of inadequate asthma symptom control despite treatment with inhaled corticosteroids according to clinical features of [NHLBI] moderate to severe persitent asthma (Step 3/4). Investigators must confirm these symptoms as outlined in Appendix 3 of the protocol (Figure 3-4a of NHLBI guidlines). Evidence of inadequate symptom control must be documented in the patient source documentation
    E.4Principal exclusion criteria
    1. previous exposure to omalizumab as a market formulation or in any other omalizumab study; patients participating in another Xolair trial even assigned to placebo or a control group are not allowed into this trial

    2. previous exposure to other humanized proteins or monoclonals

    3. known HAHA to other monoclonal antibodies

    4. use of other investigational drugs at the time of enrollment, or within 30 days of enrollment or ≤ 5 drug half-lives before enrollment, whichever is longer

    5. systemic corticosteroids (oral or IV) for reasons other than asthma maintenance therapy (e.g., asthma exacerbations or other allergic conditions) within 4 weeks prior to Visit 1

    6. use of methotrexate, gold salts or cyclosporine within 3 months prior to screening

    7. history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures

    8. known hypersensitivity to any ingredients, including excipients (arginine hydrochloride, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)

    9. clinically significant laboratory abnormalities (not associated with moderate to severe asthma) at Visit 1

    10. clinically significant abnormalities on 12-lead ECG within one month prior to or at Visit 1

    11. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by investigator or other treating physician with a positive hCG laboratory test (> 5 mIU/ml)

    12. Women of child-bearing potential (WOCBP), defined as all women physiologically
    capable of becoming pregnant, including women whose career, lifestyle, or sexual
    orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy defined by investigator or other means, UNLESS (1) they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml, OR (2) have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy OR (3) are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and copper coated IUD, any double combination of male or female condom with spermicidal gel, diaphragm, sponge, cervical cap. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout all phases of the study and is not provided by Novartis.

    13. considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits

    14. history of drug or alcohol abuse or current use of illicit drugs

    15. clinically significant uncontrolled disease or a history of such disease (e.g., infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within 3 months prior to Visit 1

    16. an active lung disease other than allergic asthma (e.g., cystic fibrosis, bronchiestasis)

    17. with elevated serum IgE levels for reasons other than allergy (e.g., parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis)

    18. involved in disease-related litigation

    19. who currently have diagnosed cancer, are currently being investigated for possible cancer or who have any history of cancer

    20. who have platelet levels ≤ 100 x 109/L at Visit 1
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events (AEs)/serious adverse events (SAEs) and immunogenicity (based on HAHA assay)
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 Yes
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 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 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 2007-07-19. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 100
    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 Decision2007-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-22
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