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Clinical trials for omalizumab (Xolair)

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    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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    67 result(s) found for: omalizumab (Xolair). Displaying page 1 of 4.
    1  2  3  4  Next»
    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: 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
    EudraCT Number: 2022-001745-20 Sponsor Protocol Number: BP11-301 Start Date*: 2023-02-02
    Sponsor Name:CuraTeQ Biologics Private Ltd.
    Full Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BP11 Versus EU-Approved Xolair® in Pati...
    Medical condition: Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Trial now transitioned) SK (Trial now transitioned) LV (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) BG (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: 2013-004910-16 Sponsor Protocol Number: P/2013/209 Start Date*: 2014-03-31
    Sponsor Name:Centre Hospitalier régional Universitaire de Besançon
    Full Title: Therapeutic multicentric phase II trial evaluating the efficacy of omalizumab (Xolair ®) in idiopathic refractory severe solar urticaria
    Medical condition:
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-002771-40 Sponsor Protocol Number: PIX-01 Start Date*: 2006-08-28
    Sponsor Name:S.G.O. Johansson, MD PhD Professor
    Full Title: Importance of IgE antibody fraction size on allergen sensitivity of basophils from cat allergic patients on Xolair. A pilot study.
    Medical condition: Allergic asthma and or rhinitis due to allergy to cat dander
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    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: 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: 2016-001001-16 Sponsor Protocol Number: Q4777n Start Date*: 2016-07-05
    Sponsor Name:F. Hoffmann-La Roche AG
    Full Title: A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Persistency of Response with or without Xolair after Long-Term Therapy (XPORT)
    Medical condition: Moderate to severe persistent allergic asthma
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 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: 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: 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: 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: 2009-012108-15 Sponsor Protocol Number: KFPIgE01 Start Date*: 2009-06-19
    Sponsor Name:Mainz University Hospital
    Full Title: Korrelation von freiem IgE mit klinischen Parametern bei Asthma-Patienten unter Therapie mit Omalizumab, einem monoklonalen Antikörper gegen körpereigenes IgE
    Medical condition: Add-on therapy to improve asthma control in patients 18-75 years of age with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and w...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-001796-17 Sponsor Protocol Number: TV45779-IMB-30086 Start Date*: 2021-11-30
    Sponsor Name:Teva Pharmaceuticals, Inc.
    Full Title: A Multinational, Multicenter, Randomized, Double Blind Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to Omalizum...
    Medical condition: Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10020197 Hives LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Completed) PL (Completed) GR (Completed) BG (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: 2020-000952-36 Sponsor Protocol Number: CT-P39_3.1 Start Date*: 2021-02-05
    Sponsor Name:CELLTRION, Inc.
    Full Title: A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients With Chronic Spontaneous Urticaria Who Remain Symptomati...
    Medical condition: Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2009-009498-87 Sponsor Protocol Number: Q4577g Start Date*: 2009-06-25
    Sponsor Name:Genentech, Inc.
    Full Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study Of Xolair (Omaluzimab) In Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Anith...
    Medical condition: Chronic Idiopathic Urticaria
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009159 Chronic urticaria LLT
    9.1 10021247 Idiopathic urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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
    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.

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