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    Summary
    EudraCT Number:2014-005127-27
    Sponsor's Protocol Code Number:CIGE025ENL01T
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-05-27
    Trial 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 number2014-005127-27
    A.3Full title of the trial
    Markers of Efficacy of Xolair (Omalizumab) in Chronic Spontaneous Urticaria
    Markers voor de effectiviteit van omalizumab bij chronische spontane urticaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mechanism of action of Xolair (omalizumab) as treatment for hives
    Werkingsmechanisme van omalizumab bij netelroos
    A.3.2Name or abbreviated title of the trial where available
    U-MEX
    U-MEX
    A.4.1Sponsor's protocol code numberCIGE025ENL01T
    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 SponsorUMC Utrecht
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointDept. Dermatology/Allergology
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3508 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+318875557388
    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 Ltd
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for injection in pre-filled syringe
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    chronische spontane urticaria
    E.1.1.1Medical condition in easily understood language
    Hives
    netelroos
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 relate the reduction of inflammatory characteristics in the skin and peripheral blood to clinical efficacy of Xolair (omalizumab) in patients with CSU.
    Het relateren van de reductie in inflammatoire kenmerken in huid en perifeer bloed, aan de klinische effectiviteit van omalizumab in patiënten met CSU.
    E.2.2Secondary objectives of the trial
    To determine the clinical efficacy of Xolair (omalizumab), measured by disease activity, disease control and quality of life
    Het bepalen van de klinische effectiviteit van omalizumab, gemeten met ziekteactiviteit, ziektecontrole en kwaliteit van leven.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥ 18 years
    Diagnosis of CSU according to recent international guidelines
    Moderate or severe disease activity (UAS7 ≥ 16) despite current treatment with H1 antihistamines according to recent international guidelines
    Sufficient washout of treatment with immunosuppressants (several washout periods are pre-defined).
    Minimale leeftijd van 18 jaar
    Diagnose CSU volgens recente Europese richtlijn
    Gemiddelde of ernstige ziekteactiviteit (UAS7 ≥ 16) ondanks behandeling met H1 antihistaminica volgens recente Europese richtlijn
    Behandeling met immunosuppressieve medicatie is voldoende lang gestaakt voorafgaand aan het onderzoek (er zijn verschillende periodes hiervoor gedefinieerd)
    E.4Principal exclusion criteria
    Other urticarias than CSU, including but not limited to CINDU
    Hypersensitivity to omalizumab or any component of the formulation
    Andere vormen van urticaria, waaronder CINDU
    Overgevoeligheid voor omalizumab of een van de hulpstoffen.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the reduction of inflammatory characteristics in the skin in responders and non-responders of treatment with Xolair (omalizumab), thereby exploring the reduction in inflammatory parameters by analysis of complement deposition and infiltration of FcεRI-bearing leukocytes such as basophils.
    Changes in inflammatory parameters in the skin will also be related to changes in levels of circulating complement components and the reduction of the in vitro activation state and numbers of basophils.
    Het primaire eindpunt is de vermindering van inflammatoire karakteristieken in de huid in patiënten met en zonder respons op omalizumab. Daartoe wordt de vermindering in complement depositie en infiltratie van FcεRI-houdende leukocyten zoals basofielen geanalyseerd.
    Veranderingen in inflammatoire karakteristieken in de huid worden daarnaast gerelateerd aan veranderingen in het bloed, namelijk circulerende complement cascade componenten, en de activatiestaat en aantallen basofiele granulocyten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Skin biopsies will be performed at baseline, after 24 hours and after 2 weeks.
    Venipunctures will be performed at baseline, 1,2, 6 and 24 hours after the first dose of omalizumab, 1 and 2 weeks after the first dose of omalizumab, before and 2 hours after the second dose of omalizumab and subsequently every 4 weeks, before the next dose of omalizumab. Three months after the last (6th) dose, a last venipuncture will be performed.
    Huidbiopten worden afgenomen voor aanvang van de behandeling en 24 uur en 2 weken na de eerste gift.
    Daarnaast zullen venapuncties plaatsvinden voor aanvang van de behandeling, 1,2, 6 en 24 uur en 1 en 2 weken na de eerste gift omalizumab, voor en 2 uur na de tweede gift omalizumab en voorafgaand aan iedere volgende gift omalizumab. Drie maanden na de laatste (6e) gift omalizumab wordt een laatste venapunctie verricht.
    E.5.2Secondary end point(s)
    Secondary endpoint is the clinical efficacy of omalizumab. Disease severity (UAS7, AAS), Quality of life (CU-QoL, AE-QoL, DLQI), and disease control (UCT) will be measured for this purpose.
    Het secundaire eindpunt is de effectiviteit van omalizumab, gemeten met ziekteactiviteit (UAS, AAS), ziekte controle (UCT) en kwaliteit van leven (CU-QoL, AE-QoL, DLQI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    UAS7 and when applicable AAS will be used throughout the study. At baseline, after three months of treatment and at the last follow up visit, CU-QoL, DLQI and if applicable AE-QoL will be used. UCT will be used every visit where patients receive a dose of omalizumab, and at the last follow-up visit.
    UAS7 en, wanneer van toepassing AAS, zullen gedurende de hele studie worden gemeten. Vragenlijsten aangaande kwaliteit van leven (CU-QoL, DLQI en indien van toepassing AE-QoL) worden ingevuld bij baseline, na 3 maanden behandeling en bij het laatste follow-up bezoek. De UCT wordt ingevuld bij iedere gift omalizumab en bij het laatste follow-up bezoek.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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.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 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 Yes
    E.8.1.7.1Other trial design description
    Prospectieve cohort studie
    prospective cohort study
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months6
    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: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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)
    None
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-29
    P. End of Trial
    P.End of Trial StatusOngoing
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