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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2014-005424-97
    Sponsor's Protocol Code Number:CIGE025EFR02
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2014-005424-97
    A.3Full title of the trial
    A phase IV, multicenter, single-arm and open-label study to explore the impact on quality of life of omalizumab (Xolair®) in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment
    Etude de phase IV, multicentrique, en ouvert, cherchant à explorer l’impact sur la qualité de vie de l’omalizumab (Xolair®) chez les patients souffrant d’urticaire chronique spontanée (UCS) réfractaires à un traitement antihistaminique anti-H1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of quality of life in chronic Spontaneous Urticaria patients and treated by omalizumab (Xolair®)
    Etude de qualité de vie chez les patients souffrant d'urticaire chronique spontanée et traités par omalizumab (Xolair®)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCIGE025EFR02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNOVARTIS PHARMA SAS
    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 supportNOVARTIS PHARMA SAS
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS PHARMA SAS
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address2 rue Lionel Terray
    B.5.3.2Town/ cityRueil-Malmaison Cedex
    B.5.3.3Post code92506
    B.5.4Telephone number33155476600
    B.5.5Fax number33155546510
    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. name Xolair
    D. of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameXolair
    D.3.2Product code IGE031
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    chronic spontaneous urticaria
    E.1.1.1Medical condition in easily understood language
    spontaneous occurrence of daily, or almost daily, hives and itching for at least 6 weeks without an obvious cause
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10072757
    E.1.2Term Chronic spontaneous urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the proportion of patients achieving disease control (urticaria control test [UCT] score of greater than or equal to 12) at Week 12 in adult patients with CSU with inadequate response to H1 antihistamine treatment and treated by omalizumab 300 mg S.C. every 4 weeks
    E.2.2Secondary objectives of the trial
    • To assess the extent to which omalizumab 300 mg S.C. controls CSU after 12 weeks of treatment using the UCT score, with or without the presence of angioedema.
    • To assess the effect of omalizumab 300 mg S.C. on QoL after 12 weeks of treatment using the chronic urticaria quality of life (CU-QoL) questionnaire; the angioedema quality of life (AE-QoL) questionnaire and the dermatology life quality index (DLQI).
    • To assess the effect of omalizumab 300 mg S.C. on CSU disease activity after 12 weeks of treatment using the urticaria activity score (UAS7).
    • To assess the effect of omalizumab 300 mg S.C. on angioedema activity after 12 weeks of treatment using the angioedema activity score (AAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients aged between 18 and 75 years.
    2.Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following:
    •The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period.
    •Weekly UAS7 score (range 0 to 42)  16 and UCT score (range 0 to 16) < 8 prior to enrollment (Day 1).
    3.Patients must document current use of an H1 antihistamine for CSU on the day of the initial visit and Day 1.
    4.Willing and able to complete a daily symptom diary (paper) for the duration of the study.
    5.Willing to give written informed consent, adhere to the visit schedules and meet clinical requirements.
    E.4Principal exclusion criteria
    1.Treatment with an investigational agent within 30 days before enrollment.
    2.Body weight less than 40 kg.
    3.Clearly defined underlying etiology for chronic urticaria other than CSU (main manifestation being physical urticaria). This includes the following urticaria types: acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact urticaria, or skin disease that includes urticarial plaques (other than CSU) such as bullous pemphigoid, dermatitis herpetiformis.
    4.The following diseases which may have symptoms of urticaria or angioedema: urticarial vasculitis, urticaria pigmentosa, erythema multiform, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, generalized cancer.
    5.Evidence of parasitic infection defined as having the following three items:
    •Risk factors for parasitic disease (living in an endemic area, chronic gastrointestinal symptoms, travel within the last 6 months to an endemic area and/or chronic immunosuppression).
    •An absolute eosinophil count more than twice the upper limit of normal (ULN).
    •Evidence of parasitic colonization or infection in 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 ULN.
    6.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.
    7.Concomitant use of cyclosporine or any other immunosuppressive agent.
    8.Hypersensitivity to omalizumab or any component of the formulation.
    9.History of anaphylactic shock.
    10.Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions that could compromise the safety of the patients.
    11.Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions. Any items that are cause for uncertainty must be reviewed with the attending physician.
    12.Inability or unwillingness to comply with the visits and follow-up procedures.
    13.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment.
    14.Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
    15.Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7
    16.Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.
    17.Any H2 antihistamine use within 7 days prior to Day -7.
    18.Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7.
    19.Evidence of current drug or alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the proportion of patients achieving disease control (urticaria control test [UCT] score of greater than or equal to 12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • To evaluate the UCT score changes, with or without the presence of angioedema.
    • To evaluate the change from baseline of chronic urticaria quality of life (CU-QoL) questionnaire; the angioedema quality of life (AE-QoL) questionnaire and the dermatology life quality index (DLQI).
    • To evaluate the change from baseline of urticaria activity score (UAS7).
    • To evaluate the change from baseline of the angioedema activity score (AAS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and over time
    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 No
    E.6.11Pharmacogenomic No
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) 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 concerned25
    E.8.5The trial involves multiple Member States No
    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 No
    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
    The study can be terminated at any time for any reason by Novartis. Reasons for terminating the study may include, but are not limited to, the following:
    •The incidence or severity of AEs in this or other studies indicates a potential health hazard to patients.
    •Patient enrollment is unsatisfactory.
    •Data recording is inaccurate or incomplete
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state126
    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)
    There will be no extension study after week 12 visit and completion of the study. Post-study treatment is at the discretion and under the full responsibility of the investigator, including a transition to commercial supply of omalizumab.
    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 Decision2015-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-11
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