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Clinical trials for omalizumab (Xolair)

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    The EU Clinical Trials Register currently displays   44351   clinical trials with a EudraCT protocol, of which   7378   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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    67 result(s) found for: omalizumab (Xolair). Displaying page 2 of 4.
    « Previous 1  2  3  4  Next»
    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: 2021-000149-42 Sponsor Protocol Number: SYN008-002 Start Date*: 2021-08-16
    Sponsor Name:Synermore Biologics Co., Ltd
    Full Title: A Phase 3, Randomized, Double-blind, Parallel group, Active Controlled Study to Compare the Efficacy and Safety of SYN008 to Xolair® in Adult Patients with Chronic Spontaneous Urticaria and Inadequ...
    Medical condition: Chronic spontaneous urticaria (Allergic asthma, Chronic rhinosinusitis with nasal polyps)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001705 Allergic asthma LLT
    20.1 10038738 - Respiratory, thoracic and mediastinal disorders 10080060 Chronic rhinosinusitis with nasal polyps PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: (No results available)
    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: 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: 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: 2010-022784-35 Sponsor Protocol Number: Q4883g Start Date*: 2011-08-08
    Sponsor Name:Genentech, Inc.
    Full Title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED SAFETY STUDY OF XOLAIR (OMALIZUMAB) IN PATIENTS WITH CHRONIC IDIOPATHIC URTICARIA (CIU) WHO REMAIN SYMPTOMATIC DESPITE TREATME...
    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: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005404-13 Sponsor Protocol Number: CIGE025ADE05 Start Date*: 2007-01-23
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A randomized, 24-week, double-blind, placebo-controlled, parallel-group, multicenter study to assess the efficacy and safety of Omalizumab in adult patients with chronic urticaria who exhibit IgE a...
    Medical condition: chronic urticaria
    Disease: Version SOC Term Classification Code Term Level
    8.1 10009159 Chronic urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-001137-41 Sponsor Protocol Number: 666 Start Date*: 2018-06-26
    Sponsor Name:Hvidovre Hospital. Dep of Respiratory Medicine
    Full Title: Use of Omalizumab will increase the pregnancy rate, proof of concept study, where women with asthma and infertility will be treated three times with weight and IgE balanced dosis at the sixth day o...
    Medical condition: infertility within female asthma patients as a result of systemic inflamation.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    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: 2013-002770-43 Sponsor Protocol Number: CUN-OMAL-UCOL Start Date*: 2013-10-28
    Sponsor Name:Clínica Universidad de Navarra/Universidad de Navarra
    Full Title: Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria.
    Medical condition: Cholinergic urticaria
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    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: 2009-009154-25 Sponsor Protocol Number: omalizumab/2009/01 Start Date*: 2009-07-07
    Sponsor Name:King's College London [...]
    1. King's College London
    2. Guy's and St.Thomas' NHS Foundation Trust
    Full Title: The effect of a humanised monoclonal anti-IgE antibody (omalizumab) on disease control and bronchial mucosal inflammation in non-atopic (“intrinsic”) asthma
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-006648-23 Sponsor Protocol Number: CIGE025A2437 Start Date*: 2008-11-12
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis
    Medical condition: Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011763 Cystic fibrosis lung LLT
    9.1 10000244 ABPA LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) NL (Prematurely Ended) GB (Prematurely Ended) IE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006559-27 Sponsor Protocol Number: OMALI2008 Start Date*: 2009-01-27
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Exploratory study on Omalizumab in patients affected by Painful Bladder Syndrome
    Medical condition: Painful bladder syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011796 Cystitis interstitial LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-005559-16 Sponsor Protocol Number: CQGE031C2201 Start Date*: 2015-07-17
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multicenter, randomized, double-blind, placebo and active-controlled phase 2b dose-finding study of QGE031 as add-on therapy to investigate the efficacy and safety in patients with Chronic Sponta...
    Medical condition: Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    18.1 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2010-022864-12 Sponsor Protocol Number: AA-10-1.01 Start Date*: 2011-04-20
    Sponsor Name:Medical Faculty, Otto-von-Guericke-University Magdeburg
    Full Title: Effect of Omalizumab (Xolair) on the threshold of degranulation and the composition of intracellular granules in skin mast cells and peripheral basophilic granulocytes before and during omalizumab ...
    Medical condition: Disease to be investigated: 12 patients with severe chronic urticaria (CU) with or without angioedema which continously need medical treatment As a control: 6 patients with atopy syndrome consisti...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10009159 Chronic urticaria LLT
    12.1 10021247 Idiopathic urticaria LLT
    12.1 10003639 Atopic dermatitis LLT
    12.1 10031673 Other atopic dermatitis and related conditions LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000883-42 Sponsor Protocol Number: APHP180614 Start Date*: 2021-01-18
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    Full Title: Impact of omalizumab withdrawal after a 3 year duration treatment in well controlled severe allergic asthma : a multicentric randomized controlled trial
    Medical condition: well controlled severe allergic asthma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10001705 Allergic asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001724-22 Sponsor Protocol Number: GA39688 Start Date*: 2017-12-21
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL 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) DE (Completed) CZ (Completed) PT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-002106-48 Sponsor Protocol Number: BCF-2009.01 Start Date*: 2012-07-06
    Sponsor Name:University College Dublin
    Full Title: An Investigative Study to characterize gene expression patterns in myeloid cells that are triggered during acute asthma exacerbations, and to identify associated genes/gene networks that are Omaliz...
    Medical condition: Asthma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
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