Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-005615-87
    Sponsor's Protocol Code Number:CIGE025EDE17T
    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:2012-07-24
    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 number2011-005615-87
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled 12-week, parallel-group study with a 6 week follow up period to demonstrate efficacy and safety of subcutaneous Omalizumab in patients with urticaria factitia refractory to standard treatment
    Eine 12-wöchige randomisierte, doppelblinde, Placebo-kontrollierte Multizenter-Studie im Parallelgruppendesign mit 6-wöchiger Nachbeobachtung zur Prüfung der Wirksamkeit und Sicherheit von Omalizumab bei Patienten mit Urticaria factitia die kein Ansprechen auf Standardtherapie zeigten.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, controlled study to assess the efficacy of Omalizumab in patients with urticaria factitia
    Eine randomiserte, kontrollierte Studie zur Nachweis der Effektivität von Omalizumab bei Patienten mit Urticaria factitia
    A.3.2Name or abbreviated title of the trial where available
    UFO
    A.4.1Sponsor's protocol code numberCIGE025EDE17T
    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 SponsorAllergie-Centrum-Charité, Charité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergie-Centrum-Charité, Charité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointHesna Gözlükaya
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number4930450518296
    B.5.5Fax number4930450518972
    B.5.6E-mailhesna.goezluekaya@charite.de
    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 Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Lyophilisate for 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 milligram(s)
    D.3.10.2Concentration typeup to
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    Urticaria factitia
    Urticaria factitia
    E.1.1.1Medical condition in easily understood language
    Urticaria induced by friction
    Urtikaria durch Scherkräfte (Schreibehaut)
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10012499
    E.1.2Term Dermatographic urticaria
    E.1.2System Organ Class 100000004858
    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 effects of 150 and 300 mg omalizumab on wheal development in UF patients
    Untersuchung der Effekte von 150 und 300 mg Omalizumab auf die Entwicklung von Urticaria factitia Symptomen.
    E.2.2Secondary objectives of the trial
    To assess the safety of omalizumab in subjects with UF
    To assess the effects of omalizumab in UF patients on quality of life, on number of symptom free days, on physician global assessment of disease severity, on patient global assessment of disease severity To assess long-term effects of omalizumab in UF patients
    Untersuchung der Sicherheit von Omalizumab bei Patienten mit Urticaria factitia
    Erfassung der Effekte von Omalizumab in Patienten mit Urticaria factitia auf die Lebensqualität, die Anzahl der symptomfreien Tage der, die allgemeine durch den Arzt und durch den Patienten erhobene Krankheitsaktivität
    Erfassung der langfristigen Effekte von Omalizumab bei Urticaria factitia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults (18 years or older)
    Informed consent signed and dated
    Able to read, understand and willing to sign the informed consent form and abide with study procedures
    Diagnosis of UF lasting for at least 6 months
    Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have SC injections administered by a qualified person
    In females of childbearing potential: Negative pregnancy test; females willing to use highly effective contraception (Pearl-Index < 1). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
    No participation in other clinical trials 4 weeks before and after participation in this study
    Erwachsene (18-75 Jahre).
    Unterschriebene und mit Datum versehene Einverständniserklärung.
    Verständnis des Studienprotokolls und Bereitschaft, dieses einzuhalten und die Einverständniserklärung zu unterzeichnen
    Diagnose einer seit mindestens 6 Monaten bestehenden Kälteurtikaria.
    Bereitschaft zur Teilnahme an studien-relevanten Maßnahmen inkl. Verabreichung der s.c. Injektion
    Anwendung einer verlässlichen Methode zur Kontrazeption bei Frauen im geburtsfähigen Alter (Pearl-Index < 1). Dies gilt nicht für post-menopausale Frauen >2 Jahre oder Sterilität (bilaterale Tubenligatur, bilaterale Oophorektomie oder Hysterektomie)
    Keine Teilnahme an klinischen Studien 4 Wochen vor und nach der Teilnahme an dieser Studie.
    E.4Principal exclusion criteria
    • Patients with acute urticaria
    • Concurrent/ongoing treatment with immunosuppressives (e.g. systemic steroids, cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer
    • Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
    • Significant concomitant illness that would adversely affect the subject’s participation or evaluation in this study
    • History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
    • Presence of clinically significant laboratory abnormalities
    • Lactating females or pregnant females
    • Subjects for whom there is concern about compliance with the protocol procedures
    • Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
    • History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject’s ability to comply with study procedures
    • Subjects who are detained officially or legally to an official institute
    • Previous use of omalizumab within the last 6 months
    • Intake of antihistamines or leukotriene antagonists within 7 days prior to visit 1
    • Intake of oral corticosteroids within 14 days prior to visit 1
    • Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study
    • Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin)
    • Begleitende Behandlung mit Immunsuppressiva (z.B. systemische Steroide, Cyclosporin, Methotrexat, Dapson oder sonstige) innerhalb von 4 Wochen oder 5 Halbwertszeiten vor Tag 0 – je nachdem, was länger zurückliegt.
    • Eine begleitende Erkrankung, die die Teilnahme des Probanden oder die Evaluation in der Studie nachteilig beeinflussen könnte.
    • Maligne Tumoren innerhalb von 5 Jahren vor Screening mit Ausnahme erfolgreich therapierter kutaner Basaliome, Spinaliome oder Cervix-Ca. in situ.
    • Auftreten von klinisch relevanten Laborabweichungen.
    • Stillende oder schwangere Frauen.
    • Personen, bei denen Bedenken hinsichtlich der Compliance besteht.
    • Jegliche gesundheitliche Beschwerden, die nach Auffassung des Prüfarztes die Teilnahme an der Studie negativ beeinflussen würden oder die Versuchsperson gefährden könnten.
    • Drogen- oder Alkoholabhängigkeit oder andere Begebenheit, die die Einhaltung des Studienprotokolls unmöglich macht (z.B. schwere psychiatrische Erkrankung).
    • Vorangegangene Einnahme von Omalizumab innerhalb der letzten 6 Monate.
    • Einnahme von Antihistaminika oder Leukotrien-Antangonisten innerhalb von 7 Tagen vor Visite 1.
    • Einnahme von oralen Kortikosteroiden innerhalb von 14 Tagen vor Visite 1.
    • Einnahme von Depot-Kortikosteroiden innerhalb von 21 Tagen vor Visite 1.
    • Bekannte Überempfindlichkeit gegenüber jeglichen Inhaltsstoffen inklusive Trägerstoffe in der Studienmedikation (Saccharose, Histidin, Polysorbat 20) oder Medikamenten im Zusammenhang mit Omalizumab (z.B. monoklonale Antikörper, polyklonales Gammaglobulin).
    E.5 End points
    E.5.1Primary end point(s)
    Change in critical friction thresholds from baseline to day 70 after treatment with omalizumab compared to placebo.
    Vergleich der Behandlung mit Omalizumab und Plazebo in Bezug auf die Änderung der Reizschwelle für die Auslösung der Urticaria factitia Symptome vom Baselinewert gegenüber nach der Behandlung an Tag 70.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 70
    Tag 70
    E.5.2Secondary end point(s)
    • To assess the safety of omalizumab in subjects with UF
    • To assess the effects of omalizumab in UF patients on quality of life, on number of symptom free days, on physician global assessment of disease severity, on patient global assessment of disease severity
    • To assess long-term effects of omalizumab in UF patients
    • Untersuchung der Sicherheit von Omalizumab bei Patienten mit Urticaria factitia
    • Erfassung der Effekte von Omalizumab in Patienten mit Urticaria factitia auf die Lebensqualität, die Anzahl der symptomfreien Tage der, die allgemeine durch den Arzt und durch den Patienten erhobene Krankheitsaktivität
    • Erfassung der langfristigen Effekte von Omalizumab bei Urticaria factitia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 28, 56, 70, 112
    Tag 28, 56, 70, 112
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number of treatment arms in the trial3
    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 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
    last visit of the last subject undergoing the trial
    Letzte Visite des letzten Studienpatienten
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state60
    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)
    Standard treatment within the respective clinics
    Standardtherapie innerhalb der entsprechenden Spezialsprechstunden
    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 Decision2012-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-25
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 05:40:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA