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    Summary
    EudraCT Number:2010-022782-99
    Sponsor's Protocol Code Number:Q4881g
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2011-02-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-022782-99
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO Evaluate the efficacy and safety OF XOLAIR (OMALIZUMAB) IN PATIENTS WITH CHRONIC IDIOPATHIC URTICARIA (CIU) WHO REMAIN SYMPTOMATIC DESPITE ANTIHISTAMINE TREATMENT (H1)
    A.3.2Name or abbreviated title of the trial where available
    ASTERIA I
    A.4.1Sponsor's protocol code numberQ4881g
    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 SponsorGenentech, Inc.
    B.1.3.4CountryUnited States
    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 holderGenentech Inc
    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.3.4Pharmaceutical 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.3.9.1CAS number 242138-07-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    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 Yes
    D.2.1.1.1Trade name XOLAIR
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech Inc
    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.3.4Pharmaceutical 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.3.9.1CAS number 242138-07-4
    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
    D.IMP: 3
    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 holderGenentech Inc
    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.3.4Pharmaceutical 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.3.9.1CAS number 242138-07-4
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    CHRONIC IDIOPATHIC URTICARIA (CIU)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10021247
    E.1.2Term Idiopathic urticaria
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective
    •To evaluate the efficacy of omalizumab compared with placebo in patients with refractory chronic idiopathic urticaria (CIU) receiving concomitant H1 antihistamine therapy
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • To evaluate the safety of omalizumab therapy in patients with refractory CIU
    • To evaluate onset of clinical effect of omalizumab therapy in CIU
    • To evaluate the dose of omalizumab therapy in patients with refractory CIU
    • To evaluate duration of response after withdrawal of omalizumab in patients with refractory CIU
    • To evaluate the quality-of-life benefit of omalizumab therapy in patients with refractory CIU
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH XOLAIR (OMALIZUMAB) STUDY Q4881g
    Date : 24 September 2010
    Version 1
    The primary objective of this study is to perform exploratory analyses to generate hypotheses identifying genes associated with treatment response, toxicity, or disease risk. If such genetic hypotheses are identified, they may be tested in future clinical studies within this therapeutic area.
    E.3Principal inclusion criteria
    Patients must meet the following criteria for study entry:
    1. Aged 12−75 years (age limits may vary dependent upon regional restrictions).
    2. Diagnosis of CIU refractory to H1 antihistamines at the time of randomization,
    as defined by all of the following:
    The presence of itch and hives for ≥ 8 consecutive weeks at any time prior
    to enrollment despite current use of H1 antihistamine treatment during this
    time period UAS7 score (range 0−42) ≥ 16 and itch component of UAS7 (range 0−21)
    ≥ 8 during 7 days prior to randomization (Week 0) In-clinic UAS ≥ 4 on at least one of the screening visit days (Day −14, Day − 7 or Day 1) Patients must have been on an approved dose of an H1 antihistamine for CIU for at least the 3 consecutive days immediately prior to the Day −14 screening visit and must document current use on the day of the initial screening visit. CIU diagnosis for ≥ 6 months.
    3. Willing to give written informed consent, adhere to the visit schedules and meet
    study requirements.For those patients below the legal age of consent, the child must be willingto give written informed assent and the parent(s)/guardian(s) must be willing to give written informed consent. For patients below the legal age of consent, both child and parent must be able to adhere to dose and visit schedules and meet study requirements.
    4. Willing and able to complete a daily symptom eDiary for the duration of the
    study.
    5. Patients must not have any missing eDiary entries in the 7 days prior to
    randomization.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study entry:
    1. Treatment with an investigational agent within 30 days of Day −14.
    2. Weight less than 20 kg (44 lbs).
    3. Clearly defined underlying etiology for chronic urticarias other than CIU (main
    manifestation being physical urticaria). This includes the following urticarias:
    Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact
    As well as the following diseases as these diseases may have symptoms
    of urticaria or angioedema Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia,
    or generalized cancer.
    4. Evidence of parasitic infection defined as having the following three items:
    Risk factors for parasitic disease (living in an endemic area, chronic GI symptoms, travel within the last 6 months to an endemic area and/or chronic immunosuppression)
    AND
    An absolute eosinophil count more than twice the upper limit of normal
    AND
    Evidence of parasitic colonization or infection on stool evaluation for ova and
    parasites. Note that stool ova and parasite evaluation will only be conducted
    in patients with both risk factors and an eosinophil count more than twice the
    upper limit of normal.
    5. Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus
    or other skin disease associated with itch.
    6. Previous treatment with omalizumab within a year prior to Day −14.
    7. Routine (daily or every other day during 5 or more consecutive days) doses of
    the following medications within 30 days prior to Day −14: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
    8. IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Day −14.
    9. Regular (daily/every other day) doxepin (oral) use within 14 days prior to
    Day −14.
    10. Any H2 antihistamine use within 7 days prior to Day −14.
    11. Any LTRA (montelukast or zafirlukast) within 7 days prior to Day −14.
    12. Any H1 antihistamines at greater than approved doses within 3 days prior to
    Day −14.
    13. Patients with current malignancy, history of malignancy, or currently under
    work-up for suspected malignancy except non-melanoma skin cancer that has
    been treated or excised and is considered resolved.
    14 .Hypersensitivity to omalizumab or any component of the formulation.
    15. History of anaphylactic shock.
    16. Presence of clinically significant cardiovascular, neurological, psychiatric,
    metabolic or other pathological conditions that could interfere with the
    interpretation of the study results and or compromise the safety of the patients.
    17. Medical examination or laboratory findings that suggest the possibility of
    decompensation of co-existing conditions for the duration of the study.
    Any items that are cause for uncertainty must be reviewed with the Medical Monitor.
    18. Inability to comply with study and follow-up procedures.
    19. Evidence of current drug or alcohol abuse.
    20. Nursing women or women of childbearing potential, 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 or other means, UNLESS 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 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or hysterectomy OR 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 double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, or cervical cap).
    21. Contraindications to diphenhydramine: Overreactivity against the agent
    diphenhydramine, other antihistaminic agents, or other components of this agent;
    acute bronchial asthma; acute angle-closure glaucoma; pheochromocytoma; hyperplasia of the prostate gland with formation of residual urine; epilepsy; hypokalemia; hypomagnesemia; bradycardia; a congenital long QT syndrome or other clinically significant cardial disorders (especially coronary heart disease, disturbances in conduction, arrhythmias); the simultaneous application of drugs which prolong the QT interval (e.g., antiarrhythmic drugs class IA or III, antibiotics, cisapride, malaria drugs, antihistaminic drugs, neuroleptic drugs) or lead to hypokalemia (e.g., certain diuretic drugs); the simultaneous application of MAO inhibitors; the simultaneous uptake of alcohol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in weekly itch score from baseline to Week 12. The analysis of the primary endpoint will consist of treatment comparisons made using analysis of covariance (ANCOVA) controlling for baseline weekly itch score, and baseline weight (less than 80 kg vs. more than or equal to 80 kg). The ANCOVA model will be based on the mITT patients. Missing Week 12 itch scores will be imputed by carrying forward the patients’ baseline scores (BOCF). The Week 12 itch scores for patients who received excluded therapy listed in Section 4.4.2 by Week 12 will also be imputed using their baseline scores.
    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 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) Yes
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.5.1Number of sites anticipated in the EEA38
    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
    The end of the study is defined as the last enrolled patient’s last visit.
    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 months10
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days14
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 101
    F.4.2.2In the whole clinical trial 301
    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 Decision2011-04-08
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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