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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:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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 3 of 4.
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    EudraCT Number: 2017-002154-36 Sponsor Protocol Number: CIGE025F1301 Start Date*: 2019-02-13
    Sponsor Name:Novartis Pharma KK
    Full Title: A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Adult and Adolescent Patients With Inadequately Controlled...
    Medical condition: Severe Japanese cedar pollinosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10036020 Pollinosis LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002298-69 Sponsor Protocol Number: CQGE031B2201 Start Date*: 2013-01-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Multi-Center, Randomized, Double Blind, Placebo and Active-Controlled study with exploratory dose-ranging, to investigate the efficacy and safety of 16 weeks treatment with subcutaneous QGE031 in...
    Medical condition: asthma
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) SK (Completed) CZ (Completed) PT (Completed) GB (Completed) HU (Completed) IT (Completed) DE (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-004085-17 Sponsor Protocol Number: 19IC5548 Start Date*: 2020-03-18
    Sponsor Name:Imperial College London
    Full Title: Treating severe paediatric asthma; a randomised controlled trial of mepolizumab and omalizumab (TREAT trial)
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-002273-35 Sponsor Protocol Number: CIGE025E2306 Start Date*: 2016-06-02
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptom...
    Medical condition: Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    19.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-004653-29 Sponsor Protocol Number: CIGE025A2432 Start Date*: 2008-05-16
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, multi-center, double-blind, placebo-controlled, parallel-group trial to explore the effects of 78 weeks omalizumab treatment as add on therapy on airway inflammation and remodeling in...
    Medical condition: Asthma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) NL (Completed) GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003350-84 Sponsor Protocol Number: CQGE031B2203 Start Date*: 2013-01-16
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, placebo- and comparator-controlled study evaluating the effect of multiple doses of QGE031 compared to omalizumab in asthma induced by allergen bronchial provocation
    Medical condition: asthma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2017-001718-28 Sponsor Protocol Number: GA39855 Start Date*: 2018-02-19
    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: BE (Completed) HU (Completed) ES (Completed) FI (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004254-25 Sponsor Protocol Number: CIGE025EDE16 Start Date*: 2012-05-10
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A randomized, double-blind, placebo-controlled, multicenter, 28-week treatment study with an 8 week follow-up period to investigate the impact of subcutaneous Omalizumab on quality of life measures...
    Medical condition: moderate to severe chronic spontaneous urticaria with angioedema
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004858 10009159 Chronic urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000840-24 Sponsor Protocol Number: CQGE031C2303 Start Date*: 2018-09-04
    Sponsor Name:Novartis Pharma AG
    Full Title: A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) ...
    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: FR (Completed) DE (Completed) BE (Completed) EE (Completed) ES (Completed) NL (Completed) PT (Not Authorised) SK (Completed) FI (Completed) PL (Completed) GB (GB - no longer in EU/EEA) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2009-010937-38 Sponsor Protocol Number: CIGE025AFR05 Start Date*: 2015-01-28
    Sponsor Name:Novartis Pharma S.A.S.
    Full Title: A 16-week treatment, multicenter, randomized, double blind, placebo-controlled, parallel-group study to assess the effect of omalizumab on the expression of FcεRI receptors of blood basophils and d...
    Medical condition: severe persistent non-atopic asthma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-005578-24 Sponsor Protocol Number: OPT-OMA-ASTHMA Start Date*: 2022-03-10
    Sponsor Name:Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
    Full Title: Therapheutic optimization of omalizumab in allergic severe asthma patients by dose and frequency of administration adjustment
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10001705 Allergic asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010914-31 Sponsor Protocol Number: CHD-PI08 Start Date*: 2009-12-02
    Sponsor Name:Dr. Christian Domingo
    Full Title: Eficacia clínica y cambios histológicos secundarios al tratamiento con omalizumab en asmáticos alérgicos en estadio V de la gina
    Medical condition: Asma
    Disease: Version SOC Term Classification Code Term Level
    9 10001705 Allergic asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000839-28 Sponsor Protocol Number: CQGE031C2302 Start Date*: 2018-08-30
    Sponsor Name:Novartis Pharma AG
    Full Title: A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) ...
    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: FR (Completed) HU (Completed) DK (Completed) ES (Completed) DE (Completed) SE (Completed) AT (Completed) GR (Completed) CZ (Completed) BG (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2006-005588-24 Sponsor Protocol Number: CIGE025A2208 Start Date*: 2007-06-08
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Multi-center, open-label, multiple dose study in mild to moderate asthmatics (with IgE/body weight combinations above that in the SmPC dosing table) to determine safety, tolerability, pharmacokinet...
    Medical condition: Mild to moderate allergic asthma
    Disease: Version SOC Term Classification Code Term Level
    8.1 10003553 Asthma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004315-13 Sponsor Protocol Number: CIGE025AMX02 Start Date*: 2017-05-08
    Sponsor Name:Novartis
    Full Title: Multicentric, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12-MonthPeriod, in Patients with Severe IgE-mediated Asthma Inadequately Controlled...
    Medical condition: Difficult to control severe asthma
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003533-10 Sponsor Protocol Number: CIGE025ABR01 Start Date*: 2016-02-16
    Sponsor Name:Novartis
    Full Title: A Randomized, Open-label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared...
    Medical condition: Severe persistent allergic asthma
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-017306-36 Sponsor Protocol Number: TIGER Start Date*: 2010-11-19
    Sponsor Name:Leiden University Medical Center, Department of Rheumatology
    Full Title: ANTI-IGE THERAPY (OMALIZUMAB) IN IGE-ACPA POSITIVE RA.
    Medical condition: RHEUMATOID ARTHRITIS
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003268 Arthritis rheumatoid LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-003860-47 Sponsor Protocol Number: CIGE025ADE03 Start Date*: 2006-02-20
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A randomized, 20 week, double-blind, placebo-controlled, parallel-group, multiple-dose, multicenter study to assess the efficacy and safety of Omalizumab in combination with Depigoid, versus Depigo...
    Medical condition: Asthma extrinsic
    Disease: Version SOC Term Classification Code Term Level
    M15 10003558 LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-003524-11 Sponsor Protocol Number: CIG025A2426 Start Date*: 2006-09-19
    Sponsor Name:University Hospital Gent
    Full Title: Clinical and biological effects of Anti-IgE (Omalizumab) in patients with bilateral nasal polyposis and asthma
    Medical condition: patients with nasal polyps and comorbid asthma
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028756 Nasal polyps LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002759-39 Sponsor Protocol Number: 20190194 Start Date*: 2021-04-01
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria
    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: GR (Completed) FR (Completed) IT (Completed) ES (Ongoing) PL (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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