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Clinical trials for Omalizumab

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   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    85 result(s) found for: Omalizumab. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2015-003536-12 Sponsor Protocol Number: CIGE025B1301E1 Start Date*: 2016-02-16
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite...
    Medical condition: Allergic Asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005127-27 Sponsor Protocol Number: CIGE025ENL01T Start Date*: 2015-05-29
    Sponsor Name:UMC Utrecht
    Full Title: Markers of Efficacy of Xolair (Omalizumab) in Chronic Spontaneous Urticaria
    Medical condition: Chronic spontaneous urticaria
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004427-37 Sponsor Protocol Number: 5421234 Start Date*: 2019-02-20
    Sponsor Name:Odense Research Centre for Anaphylaxis (ORCA)
    Full Title: Treatment with Omalizumab in food allergic children
    Medical condition: Food Allergy with Anaphylaxis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10064075 Seafood allergy LLT
    20.0 100000004870 10014315 Egg allergy LLT
    20.0 100000004870 10016709 Fish allergy LLT
    20.0 100000004870 10040539 Shellfish allergy LLT
    20.0 100000004870 10001745 Allergy to cow's milk LLT
    20.1 100000004870 10034202 Peanut allergy LLT
    20.0 100000004870 10011240 Cow's milk allergy LLT
    20.1 100000004870 10054957 Allergy to grains LLT
    20.1 100000004870 10054959 Allergy to nuts LLT
    20.0 100000004870 10076438 Milk protein allergy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003119-21 Sponsor Protocol Number: 1 Start Date*: 2017-12-22
    Sponsor Name:Medical University of Vienna
    Full Title: Effect of Omalizumab in patients with Aspirin-Exazerbated Respiratory Disease (AERD)
    Medical condition: Aspirin-exacerbated respiratory disease (AERD), also known as Samter's triad or Widal's triad, comprises the triad of Asthma, chronic rhinosinusitis with nasal polyps (CRwNP) and nonsteroidal anti-...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005615-87 Sponsor Protocol Number: CIGE025EDE17T Start Date*: 2012-11-06
    Sponsor Name:Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin
    Full Title: 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 wi...
    Medical condition: Urticaria factitia
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004858 10012499 Dermatographic urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-001013-41 Sponsor Protocol Number: CIGE025A2210 Start Date*: 2008-01-18
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, placebo-controlled study to demonstrate the efficacy of Xolair in an allergen bronchoprovocation study in two asthmatic populations defined by serum IgE concentrations
    Medical condition: Asthma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-000829-27 Sponsor Protocol Number: LPS16747 Start Date*: 2021-09-23
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: A randomized, double-blind, head-to-head comparison of dupilumab versus omalizumab in severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and comorbid asthma patients
    Medical condition: Chronic rhinosinusitis with nasal polyps
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038738 - Respiratory, thoracic and mediastinal disorders 10080060 Chronic rhinosinusitis with nasal polyps PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) BE (Completed) CZ (Completed) FI (Completed) HU (Completed) SE (Completed) ES (Ongoing) DK (Completed) PT (Completed) PL (Completed) IT (Completed) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002473-19 Sponsor Protocol Number: PNEU-ASTHMA-02 Start Date*: 2018-11-13
    Sponsor Name:Cliniques Universitaires Saint-Luc
    Full Title: PREDICTIVE FACTORS AND MAGNITUDE OF RESPONSE TO OMALIZUMAB AND MEPOLIZUMAB IN ALLERGIC AND EOSINOPHILIC SEVERE ASTHMA: A MULTICENTER PRAGMATIC TRIAL IN BELGIUM
    Medical condition: Adult patients (at least 18yrs-old) with severe asthma and eligible for both XOLAIR and NUCALA therapies, and agreeing on participating (signature of a written informed consent).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-018559-84 Sponsor Protocol Number: AMB-WEI-1052-I Start Date*: 2010-07-20
    Sponsor Name:Medizinische Fakultät der technischen Universität Muenchen
    Full Title: AMBITIOUS Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage Single- arm trial to identify potential markers underlying variability in response to Omalizumab (Xolair®) treatment i...
    Medical condition: AMBITIOUS is a trial to identify potential markers underlying variability in response to Omalizumab (Xolair®) treatment in atopic dermatitis Atopische Dermatitis is a common inflammatory skin disea...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10040785 - Skin and subcutaneous tissue disorders 10029264 Neurodermatitis aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005424-97 Sponsor Protocol Number: CIGE025EFR02 Start Date*: 2015-01-28
    Sponsor Name:NOVARTIS PHARMA SAS
    Full Title: 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...
    Medical condition: chronic spontaneous urticaria
    Disease: Version SOC Term Classification Code Term Level
    18.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-024113-31 Sponsor Protocol Number: CUN-OMAL-CU-2010 Start Date*: 2011-08-08
    Sponsor Name:Instituto Científico y Tecnológico de Navarra
    Full Title: Ensayo clínico multicéntrico, doble ciego, controlado con placebo, cruzado (2x2) con aleatorización de la secuencia, para evaluar la eficacia y seguridad de Omalizumab (Xolair®, Novartis) en una nu...
    Medical condition: Pacientes con urticaria crónica grave que no responden a dosis aprobadas de antihistamínicos
    Disease: Version SOC Term Classification Code Term Level
    13 10009159 Urticaria crónica LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-004216-31 Sponsor Protocol Number: CIGE025E2201 Start Date*: 2012-03-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase II, multi-centre, randomized, double blind, placebo-controlled study to determine the mode of action of omalizumab in patients with chronic idiopathic urticaria (CIU) who remain symptomatic...
    Medical condition: Chronic Idiopathic Urticaria
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10009159 Chronic urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022785-27 Sponsor Protocol Number: Q4882g Start Date*: Information not available in EudraCT
    Sponsor Name:Genentech, Inc.
    Full Title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING, PLACEBO-CONTROLLED STUDY TO Evaluate the efficacy, RESPONSE DURATION and safety OF XOLAIR (OMALIZUMAB) IN PATIENTS WITH CHRONIC IDI...
    Medical condition: CHRONIC IDIOPATHIC URTICARIA (CIU)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10021247 Idiopathic urticaria LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Completed) DK (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-022782-99 Sponsor Protocol Number: Q4881g Start Date*: Information not available in EudraCT
    Sponsor Name:Genentech, Inc.
    Full Title: 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 (...
    Medical condition: CHRONIC IDIOPATHIC URTICARIA (CIU)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10021247 Idiopathic urticaria LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Completed) DK (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-003534-27 Sponsor Protocol Number: CIGE025B1301 Start Date*: 2016-02-16
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A 24 Week, Open Label, Multi-center Evaluation of Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic ...
    Medical condition: Allergic asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001799-41 Sponsor Protocol Number: CIGE025AUS33 Start Date*: 2017-08-03
    Sponsor Name:Novartis Pharmaceutical Corporation
    Full Title: A 26-week randomized, double-blind, placebo-controlled, multi-center study to evaluate the effect of omalizumab on markers of asthma impairment in patients with persistent allergic asthma
    Medical condition: Allergic asthma
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-001099-11 Sponsor Protocol Number: CIGE025A2425 Start Date*: 2005-10-18
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, open label, parallel-group, international, multicenter study evaluating persistency of response to omalizumab during 32 weeks treatment given as add on to optimized asthma therapy in ...
    Medical condition: Severe persistent allergic asthma
    Disease: Version SOC Term Classification Code Term Level
    8.1 10001705 Allergic asthma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NO (Completed) IE (Completed) ES (Completed) DK (Completed) SE (Completed) DE (Completed) HU (Completed) PT (Not Authorised) IT (Completed) BE (Completed) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003450-16 Sponsor Protocol Number: WA40169 Start Date*: 2018-06-04
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: OPEN-LABEL EXTENSION STUDY OF OMALIZUMAB IN PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS
    Medical condition: Chronic rhinosinusitis with nasal polyps
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028756 Nasal polyps PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) PT (Completed) FI (Completed) CZ (Completed) BE (Completed) DE (Completed) HU (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-003746-41 Sponsor Protocol Number: CIGE025EDE14T Start Date*: 2012-01-12
    Sponsor Name:Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin
    Full Title: A two-center, double blind, placebo-controlled study in parallel design to assess the efficacy and safety of 150 and 300 mg omalizumab in subjects with antihistamine-resistant cold contact urticari...
    Medical condition: Cold contact urticaria
    Disease: Version SOC Term Classification Code Term Level
    15.1 10040785 - Skin and subcutaneous tissue disorders 10009869 Cold urticaria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005625-78 Sponsor Protocol Number: FASTXP2013 Start Date*: 2013-06-24
    Sponsor Name:Karolinska Institutet
    Full Title: Food Allergy Surpression Therapy during protection with Xolair
    Medical condition:
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
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    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
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